Adopted at the 7th meeting of the Standing Committee of the Sixth National People’s Congress on September 20, 1984, the 20th meeting of the Standing Committee of the Ninth National People’s Congress on February 28, 2001, the first amendment was made according to the Decision on Amending the Marine Environmental Protection Law of the People’s Republic of China and other seven laws at the 6th meeting of the Standing Committee of the 12th National People’s Congress on December 28, 2013, the second amendment was made according to the Decision on Amending the Drug Administration Law of the People’s Republic of China at the 14th meeting of the Standing Committee of the 12th National People’s Congress on April 24, 2015, and the second amendment was made at the 12th meeting of the Standing Committee of the 13th National People’s Congress on August 26, 2019.

Contents

Chapter I General Provisions

Chapter II Drug Development and Registration

Chapter III Drug Marketing Authorization Holder

Chapter IV Pharmaceutical Production

Chapter V Pharmaceutical Business

Chapter VI Pharmaceutical Affairs Management of Medical Institutions

Chapter VII Post-marketing Management of Drugs

Chapter VIII Drug Prices and Advertisements

Chapter IX Drug Reserve and Supply

Chapter X Supervision and Management

Chapter XI Legal Liability

Chapter XII Supplementary Provisions

Chapter I General Provisions

Article 1 This Law is formulated for the purpose of strengthening drug administration, ensuring drug quality, safeguarding public drug safety and legitimate rights and interests, and protecting and promoting public health.

Article 2 This Law shall apply to activities engaged in drug research, production, operation, use, supervision and administration within the territory of the People’s Republic of China.

The term “drugs” as mentioned in this Law refers to substances used to prevent, treat and diagnose human diseases, purposefully regulate human physiological functions and stipulate indications or functional indications, usage and dosage, including traditional Chinese medicines, chemical drugs and biological products.

Article 3 Drug management shall take people’s health as the center, adhere to the principles of risk management, whole-process control, and social co-governance, establish a scientific and strict supervision and management system, comprehensively improve the quality of drugs, and ensure the safety, effectiveness, and accessibility of drugs.

Article 4 The state develops modern medicine and traditional medicine and gives full play to its role in prevention, medical treatment and health care.

The state protects wild medicinal resources and traditional Chinese medicine varieties and encourages the cultivation of authentic Chinese medicinal materials.

Article 5 The state encourages the research and creation of new drugs, and protects the legitimate rights and interests of citizens, legal persons and other organizations in the research and development of new drugs.

Article 6 The state implements the drug marketing license holder system for drug administration. The drug marketing authorization holder is responsible for the safety, effectiveness and quality controllability of the drug in the whole process of drug development, production, operation and use according to law.

Article 7 Those engaged in drug research, production, operation and use activities shall abide by laws, regulations, rules, standards and norms, and ensure that the information in the whole process is true, accurate, complete and traceable.

Article 8 The drug supervision and administration department under the State Council is in charge of the national drug supervision and administration. The relevant departments of the State Council are responsible for the supervision and administration of drugs within their respective responsibilities. The pharmaceutical supervision and administration department under the State Council shall cooperate with relevant departments under the State Council to implement the national pharmaceutical industry development plan and industrial policies.

The drug supervision and administration departments of the PRC governments of provinces, autonomous regions and municipalities directly under the Central Government are responsible for drug supervision and administration within their respective administrative areas. The departments responsible for drug supervision and administration of the PRC governments at the municipal and county levels divided into districts (hereinafter referred to as drug supervision and administration departments) are responsible for drug supervision and administration within their respective administrative areas. The relevant departments of the local PRC governments at or above the county level are responsible for the supervision and administration of drugs within their respective responsibilities.

Article 9 The local PRC at or above the county level shall be responsible for the drug supervision and administration within their respective administrative areas, uniformly lead, organize and coordinate the drug supervision and administration within their respective administrative areas and the response to drug safety emergencies, and establish and improve the drug supervision and administration mechanism and information sharing mechanism.

Article 10 PRC governments at or above the county level shall incorporate drug safety work into the national economic and social development plan at the corresponding level, include drug safety work funds into the government budget at the corresponding level, strengthen drug supervision and management capacity building, and provide guarantee for drug safety work.

Article 11 The drug professional and technical institutions set up or designated by the drug supervision and administration department shall undertake the review, inspection, verification, monitoring and evaluation required for the implementation of drug supervision and administration in accordance with the law.

Article 12 The state shall establish and improve the drug traceability system. The drug supervision and administration department of the State Council shall formulate unified drug traceability standards and norms, promote the exchange and sharing of drug traceability information, and realize drug traceability.

The state established a pharmacovigilance system to monitor, identify, evaluate and control adverse drug reactions and other harmful reactions related to drug use.

Article 13 PRC governments at all levels and their relevant departments, pharmaceutical industry associations, etc. shall strengthen drug safety publicity and education, and carry out the popularization of drug safety laws and regulations.

The news media should carry out public welfare publicity on drug safety laws and regulations and supervise drug violations by public opinion. Publicity reports on drugs should be comprehensive, scientific, objective and fair.

Article 14 Pharmaceutical industry associations shall strengthen industry self-discipline, establish and improve industry norms, promote the construction of industry integrity systems, and guide and urge members to carry out activities such as pharmaceutical production and operation in accordance with the law.

Article 15 The PRC governments at or above the county level and their relevant departments shall commend and reward units and individuals who have made outstanding contributions to the research, production, operation, use, supervision and management of drugs in accordance with relevant state regulations.

Chapter II Drug Development and Registration

Article 16 The state supports drug innovation that is oriented by clinical value and has clear or special curative effects on human diseases and encourages the development of new drugs with new therapeutic mechanisms, treatment of serious life-threatening diseases or rare diseases, and multi-targeted systemic regulation and intervention functions for human body, so as to promote the progress of drug technology.

The state encourages the use of modern science and technology and traditional Chinese medicine research methods to carry out scientific and technological research and drug development of traditional Chinese medicine, establish and improve a technical evaluation system that conforms to the characteristics of traditional Chinese medicine, and promote the inheritance and innovation of traditional Chinese medicine.

The state takes effective measures to encourage the research and innovation of children’s drugs, support the development of new varieties, dosage forms and specifications of children’s drugs that meet the physiological characteristics of children, and give priority to the review and approval of children’s drugs.

Article 17 When engaged in drug research and development activities, one shall abide by the quality management standards for drug non-clinical research and drug clinical trials and ensure that the whole process of drug development continues to meet the statutory requirements.

The quality management standards for drug non-clinical research and the quality management standards for drug clinical trials shall be formulated by the drug supervision and administration department of the State Council in conjunction with relevant departments of the State Council.

Article 18 Non-clinical research on drugs shall comply with the relevant provisions of the state, have personnel, sites, equipment, instruments and management systems suitable for the research project, and ensure the authenticity of relevant data, materials and samples.

Article 19 To carry out drug clinical trials, relevant data, materials and samples such as development methods, quality indicators, pharmacological and toxicological test results shall be truthfully submitted in accordance with the provisions of the drug regulatory department of the State Council and approved by the drug regulatory department of the State Council. The drug supervision and administration department under the State Council shall decide whether to agree or not within 60 working days from the date of accepting the clinical trial application and notifying the clinical trial sponsor. If the notification is not made within the time limit, it shall be deemed to have agreed. Among them, if the bio equivalence test is carried out, it shall be reported to the drug regulatory authority of the State Council for the record.

Clinical trials of drugs should be carried out in clinical trial institutions with corresponding conditions. Drug clinical trial institutions shall implement record management, and the specific measures shall be jointly formulated by the drug supervision and administration department of the State Council and the competent health department of the State Council.

Article 20 Drug clinical trials should comply with ethical principles, formulate clinical trial plans, and be reviewed and approved by the ethics committee.

The ethics committee shall establish an ethical review work system to ensure that the ethical review process is independent, objective and fair, supervise and standardize the conduct of drug clinical trials, protect the legitimate rights and interests of subjects, and safeguard social and public interests.

Article 21 When implementing drug clinical trials, the purpose and risks of the clinical trial shall be truthfully explained and explained to the subjects or their guardians, the informed consent form voluntarily signed by the subjects or their guardians shall be obtained, and effective measures shall be taken to protect the legitimate rights and interests of the subjects.

Article 22 During a drug clinical trial, if safety problems or other risks are found, the clinical trial sponsor shall promptly adjust the clinical trial plan, suspend or terminate the clinical trial, and report to the drug regulatory department of the State Council. When necessary, the drug regulatory authority under the State Council may order the adjustment of the clinical trial plan, suspend or terminate the clinical trial.

Article 23 For drugs that are undergoing clinical trials to treat diseases that are seriously life-threatening and have no effective treatment, if they may benefit from medical observation and conform to ethical principles, they can be used for other patients with the same condition in institutions where clinical trials are carried out after review and informed consent.

Article 24 Drugs marketed in China shall be approved by the drug regulatory department of the State Council and obtain a drug registration certificate; However, Chinese herbal medicines and Chinese herbal pieces that have not been subject to examination and approval management are excepted. The catalogue of Chinese herbal medicines and Chinese herbal pieces subject to examination and approval management shall be formulated by the drug supervision and administration department under the State Council in conjunction with the competent department of traditional Chinese medicine under the State Council.

When applying for drug registration, true, sufficient and reliable data, materials and samples should be provided to prove the safety, effectiveness and quality controllability of the drug.

Article 25 For drugs applying for registration, the drug regulatory department of the State Council shall organize pharmaceutical, medical and other technical personnel to review the safety, effectiveness and quality controllability of the drugs, as well as the applicant’s quality management, risk prevention and control and liability compensation capabilities shall be reviewed; If the conditions are met, a drug registration certificate will be issued.

When examining and approving drugs, the drug supervision and administration department of the State Council shall review and approve chemical raw materials, relevant excipients, packaging materials and containers that come into direct contact with drugs, and review the quality standards, production processes, labels and instructions of drugs together. Approval.

The term “excipients” as mentioned in this Law refers to the excipients and additives used in the production of drugs and the formulation of prescriptions.

Article 26 For the treatment of diseases that are seriously life-threatening and there is no effective treatment, as well as drugs urgently needed in public health, if the data of clinical trials of drugs show curative effect and can predict their clinical value, they may be approved with conditions, and relevant matters may be stated in the drug registration certificate.

Article 27 The drug regulatory department of the State Council shall improve the drug review and approval system, strengthen capacity building, establish and improve communication, expert consultation and other mechanisms, optimize the review and approval process, and improve the efficiency of review and approval.

The review conclusions and basis of approved drugs for marketing shall be made public in accordance with the law and subject to social supervision. Trade secrets learned during review and approval shall be kept confidential.

Article 28 Drugs shall comply with national drug standards. If the drug quality standard approved by the drug supervision and administration department of the State Council is higher than the national drug standard, the approved drug quality standard shall be implemented; If there is no national drug standard, it shall comply with the approved drug quality standard.

The Pharmacopoeia of the People’s Republic of China and drug standards promulgated by the drug supervision and administration department of the State Council are national drug standards.

The drug supervision and administration department of the State Council, together with the competent health department of the State Council, organizes a pharmacopoeia committee to be responsible for the formulation and revision of national drug standards.

The drug inspection institution set up or designated by the drug supervision and administration department under the State Council is responsible for calibrating national drug standards and reference substances.

Article 29 The names of drugs listed in the national drug standards are generic names of drugs. If it has been used as a generic name of a drug, the name shall not be used as a drug trademark.

Chapter III Drug Marketing Authorization Holder

Article 30 The holder of a drug marketing license refers to an enterprise or drug research and development institution that has obtained a drug registration certificate.

The holder of a drug marketing license shall, in accordance with the provisions of this Law, bear responsibility for non-clinical research, clinical trials, production and operation, post-marketing research, adverse reaction monitoring, reporting and treatment of drugs. Other units and individuals engaged in drug research, production, operation, storage, transportation, use and other activities shall bear corresponding responsibilities in accordance with the law.

The legal representative and principal person in charge of the drug marketing license holder shall be fully responsible for the quality of the drug.

Article 31 The holder of a drug marketing license shall establish a drug quality assurance system and assign specialized personnel to be independently responsible for drug quality management.

The holder of the drug marketing license shall conduct regular audits on the quality management system of the entrusted drug manufacturer and drug dealer and supervise their continuous quality assurance and control capabilities.

Article 32 The holder of a drug marketing license may produce drugs by itself or entrust a drug manufacturer to produce them.

If the holder of a drug marketing license produces a drug by itself, it shall obtain a drug production license in accordance with the provisions of this Law; If production is entrusted, a qualified pharmaceutical production enterprise shall be entrusted. The drug marketing holder and the entrusted production enterprise shall sign an entrustment agreement and a quality agreement, and strictly fulfil the obligations stipulated in the agreement.

The drug supervision and administration department under the State Council formulates guidelines for drug entrusted production quality agreements to guide and supervise drug marketing license holders and entrusted production enterprises to fulfill their drug quality assurance obligations.

Blood products, narcotic drugs, psychotropic drugs, medical toxic drugs and pharmaceutical precursor chemicals shall not be entrusted for production; However, unless otherwise stipulated by the drug supervision and administration department of the State Council.

Article 33 The holder of a drug marketing license shall establish drug marketing release procedures, review the drugs released by the drug manufacturer, and can only be released after being signed by the quality authorized person. Those that do not meet the national drug standards shall not be released.

Article 34 The holder of a drug marketing license may sell the drugs for which it has obtained a drug registration certificate by itself or entrust a drug trading enterprise to sell them. If the holder of a drug marketing license engages in drug retail activities, the holder shall obtain a drug business license.

If the holder of a drug marketing license sells drugs by itself, it shall meet the conditions stipulated in Article 52 of this Law; Entrusted sales shall be entrusted to qualified pharmaceutical trading enterprises. The drug marketing license holder and the entrusted business enterprise shall sign an entrustment agreement and strictly perform the obligations stipulated in the agreement.

Article 35 Where a drug marketing license holder, a drug manufacturer, or a drug trading enterprise entrusts the storage and transportation of drugs, it shall evaluate the quality assurance capabilities and risk management capabilities of the entrusted party, sign an entrust agreement with it, stipulate drug quality responsibilities, operating procedures, etc., and supervise the entrusted party.

Article 36 Drug marketing license holders, drug manufacturers, drug dealers and medical institutions shall establish and implement a drug traceability system, provide traceability information in accordance with regulations, and ensure the traceability of drugs.

Article 37 The holder of a drug marketing license shall establish an annual reporting system, and report the production and sales of drugs, post-marketing research, risk management, etc. to the drug regulatory authorities of the PRC governments of provinces, autonomous regions, and municipalities directly under the Central Government every year in accordance with regulations.

Article 38 If the holder of a drug marketing license is an overseas enterprise, the enterprise legal person designated by it in China shall perform the obligations of the holder of the drug marketing license and bear joint and several liability with the holder of the drug marketing license.

Article 39 Chinese herbal decoction pieces production enterprises shall fulfill the relevant obligations of drug marketing license holders, implement the whole process management of the production and sales of Chinese herbal decoction pieces, establish a traceability system for Chinese herbal decoction pieces, and ensure the safety, effectiveness and traceability of Chinese herbal decoction pieces.

Article 40 With the approval of the drug regulatory department under the State Council, the holder of the drug marketing license may transfer the drug marketing license. The transferee shall have the ability of quality management, risk prevention and control, and liability compensation to ensure the safety, effectiveness and quality controllability of the drug, and fulfill the obligations of the drug marketing license holder.

Chapter IV Pharmaceutical Production

Article 41 To engage in drug production activities, a drug production license shall be obtained with the approval of the drug supervision and administration department of the PRC government of the province, autonomous region or municipality directly under the Central Government where it is located. Without a pharmaceutical production license, no pharmaceutical shall be produced.

The pharmaceutical production license shall indicate the validity period and production scope, and the license shall be re-examined and issued when it expires.

Article 42 To engage in pharmaceutical production activities, the following conditions shall be met:

(1) There are pharmaceutical technicians, engineering technicians and corresponding skilled workers who have been qualified according to law;

(2) There are factories, facilities and a sanitary environment suitable for pharmaceutical production;

(3) There are institutions, personnel and necessary instruments and equipment capable of quality management and quality inspection of the drugs produced;

(4) There are rules and regulations to ensure the quality of drugs and meet the requirements of drug production quality management practices formulated by the drug regulatory department of the State Council in accordance with this Law.

Article 43 When engaged in drug production activities, one shall abide by the drug production quality management standards, establish and improve the drug production quality management system, and ensure that the whole process of drug production continues to meet the statutory requirements.

The legal representative and principal responsible person of a pharmaceutical production enterprise shall be fully responsible for the pharmaceutical production activities of the enterprise.

Article 44 Drugs shall be produced in accordance with the national drug standards and the production process approved by the drug supervision and administration department. Production and inspection records shall be complete and accurate and shall not be fabricated.

Chinese herbal pieces should be processed in accordance with national drug standards; If there is no provision in the national drug standards, it shall be processed in accordance with the processing specifications formulated by the drug supervision and administration departments of the PRC governments of provinces, autonomous regions and municipalities directly under the Central Government. The processing specifications formulated by the drug regulatory authorities of the PRC governments of provinces, autonomous regions and municipalities directly under the Central Government shall be reported to the drug regulatory authorities of the State Council for the record. Those that do not meet the national drug standards or are not processed in accordance with the processing specifications formulated by the drug supervision and administration departments of the PRC governments of provinces, autonomous regions or municipalities directly under the Central Government shall not leave the factory or be sold.

Article 45 The raw materials and auxiliary materials required for the production of drugs shall meet the relevant requirements of pharmaceutical requirements and pharmaceutical manufacturing quality management standards.

When producing drugs, suppliers who supply raw materials and auxiliary materials shall be audited in accordance with regulations to ensure that the purchased and used raw materials and auxiliary materials meet the requirements specified in the preceding paragraph.

Article 46 The packaging materials and containers that come into direct contact with drugs shall meet the medicinal requirements and the standards for ensuring human health and safety.

Unqualified packaging materials and containers that are in direct contact with drugs shall be ordered by the drug supervision and administration department to stop using them.

Article 47 Pharmaceutical manufacturing enterprises shall conduct quality inspections on drugs. Those that do not meet the national drug standards are not allowed to leave the factory.

Pharmaceutical manufacturers shall establish drug release procedures and clarify the standards and conditions for ex-factory release. If it meets the standards and conditions, it can only be released after being signed by the quality authorized person.

Article 48 The packaging of drugs shall meet the requirements of drug quality and be convenient for storage, transportation and medical use.

The shipment of Chinese herbal medicines should be packaged. On each package, the product name, place of origin, date and supplier shall be indicated, and the mark of qualified quality shall be attached.

Article 49 Pharmaceutical packaging shall be printed or labeled with instructions in accordance with regulations.

The label or instructions shall indicate the generic name, ingredients, specifications, marketing authorization holder and address, manufacturer and its address, approval number, product batch number, production date, expiration date, indications or functional indications, usage, dosage, contraindications, adverse reactions and precautions of the drug. The words in labels and instructions should be clear, and the production date, expiration date and other matters should be prominently marked and easily identified.

The labels and instructions of narcotic drugs, psychotropic drugs, toxic drugs for medical use, radioactive drugs, drugs for external use and over-the-counter drugs shall be printed with the prescribed marks.

Article 50 The staff of drug marketing license holders, drug manufacturers, drug dealers and medical institutions who are in direct contact with drugs shall undergo annual health examinations. Those suffering from infectious diseases or other diseases that may contaminate drugs are not allowed to engage in direct contact with drugs.

Chapter V Pharmaceutical Business

Article 51 To engage in drug wholesale activities, a drug business license shall be obtained with the approval of the drug supervision and administration department of the PRC government of the province, autonomous region or municipality directly under the Central Government where it is located. To engage in drug retail activities, one shall obtain the approval of the drug supervision and administration department of the local PRC government at or above the county level and obtain a drug business license. Without a pharmaceutical business license, it is not allowed to deal in pharmaceuticals.

The pharmaceutical business license shall indicate the validity period and business scope, and the license shall be re-examined and issued when it expires.

In addition to the conditions stipulated in Article 52 of this Law, the drug supervision and administration department shall follow the principle of facilitating the purchase of drugs by the masses when implementing the drug business license.

Article 52 The following conditions shall be met to engage in pharmaceutical business activities:

(1) There are pharmacists or other pharmaceutical technicians who have been qualified according to law;

(2) Having business premises, equipment, storage facilities and sanitary environment suitable for the drugs it deals in;

(3) Having quality management institutions or personnel suitable for the drugs they operate;

(4) There are rules and regulations to ensure the quality of drugs and meet the requirements of drug business quality management standards formulated by the drug regulatory department of the State Council in accordance with this Law.

Article 53 When engaged in pharmaceutical business activities, one shall abide by the pharmaceutical business quality management norms, establish and improve the pharmaceutical business quality management system, and ensure that the whole process of pharmaceutical business continues to meet the statutory requirements.

The state encourages and guides pharmaceutical retail chain operations. The headquarters of an enterprise engaged in pharmaceutical retail chain operation activities shall establish a unified quality management system and perform management responsibilities for the business activities of its affiliated retail enterprises.

The legal representative and principal person in charge of a pharmaceutical trading enterprise shall be fully responsible for the pharmaceutical trading activities of the enterprise.

Article 54 The state implements a classified management system for prescription drugs and over-the-counter drugs. Specific measures shall be formulated by the drug supervision and administration department of the State Council in conjunction with the competent health department of the State Council.

Article 55 Drug marketing license holders, pharmaceutical manufacturers, pharmaceutical trading enterprises and medical institutions shall purchase drugs from drug marketing license holders or enterprises with drug production and operation qualifications; However, the purchase of Chinese herbal medicines that have not been subject to examination and approval management is excepted.

Article 56 When purchasing drugs, a pharmaceutical trading enterprise shall establish and implement the incoming inspection and acceptance system and verify the drug qualification certificate and other marks; Those that do not meet the prescribed requirements shall not be purchased or sold.

Article 57 When purchasing and selling drugs, a pharmaceutical enterprise shall have a true and complete record of purchase and sale. The purchase and sale record shall indicate the generic name, dosage form, specification, product batch number, validity period, marketing license holder, manufacturer, purchase and sale unit, purchase and sale quantity, purchase and sale price, purchase and sale date of the drug and other contents stipulated by the drug regulatory authority under the State Council.

Article 58 The retail drugs of pharmaceutical trading enterprises shall be accurate and correctly explain the usage, dosage and precautions; The prescription shall be checked, and the drugs listed in the prescription shall not be changed or substituted without authorization. Prescriptions with contraindications or over-doses should be refused to be formulated; If necessary, it can only be dispensed after correction or re-signature by the prescribing physician.

When a pharmaceutical enterprise sells Chinese herbal medicines, it shall indicate the place of origin.

Pharmacists or other pharmaceutical technicians who have been qualified according to law are responsible for the company’s drug management, prescription review and deployment, and rational drug use guidance.

Article 59 Pharmaceutical trading enterprises shall formulate and implement a drug storage system, and take necessary measures such as refrigeration, anti-freezing, moisture prevention, insect prevention and rodent prevention to ensure the quality of drugs.

The inspection system shall be implemented for the warehousing and delivery of drugs.

Article 60 Chinese herbal medicines may be sold in urban and rural fairs, unless otherwise stipulated by the State Council.

Article 61 Drug marketing license holders and drug trading enterprises who sell drugs through the Internet shall abide by the relevant provisions of this Law on drug trading. Specific management measures shall be formulated by the drug supervision and administration department of the State Council in conjunction with the competent health department of the State Council and other departments.

Vaccines, blood products, narcotic drugs, psychotropic drugs, medical toxic drugs, radioactive drugs, pharmaceutical precursor chemicals and other drugs subject to special management by the state shall not be sold on the Internet.

Article 62 Third-party platform providers for drug online transactions shall, in accordance with the provisions of the drug regulatory department of the State Council, file with the drug regulatory department of the PRC government of the province, autonomous region, or municipality directly under the Central Government where it is located.

Third-party platform providers shall review the qualifications of drug marketing license holders and drug trading enterprises applying to enter the platform in accordance with the law, ensure that they meet the statutory requirements, and manage the drug trading behaviors that occur on the platform.

If a third-party platform provider finds that the drug marketing license holder or drug trading enterprise entering the platform has violated the provisions of this Law, it shall promptly stop it and immediately report to the drug supervision and administration department of the local county-level PRC government; If a serious illegal act is found, it shall immediately stop providing online trading platform services.

Article 63 Newly discovered and introduced medicinal materials from abroad can only be sold after being approved by the drug regulatory department under the State Council.

Article 64 Drugs shall be imported from ports where drugs are allowed to be imported, and the enterprise importing drugs shall file with the drug supervision and administration department where the port is located. The customs shall handle the customs clearance formalities with the customs clearance form of imported drugs issued by the drug supervision and administration department. If there is no customs clearance form for imported drugs, the customs shall not release them.

The drug supervision and administration department where the port is located shall notify the drug inspection agency to conduct spot checks and inspections of imported drugs in accordance with the provisions of the drug supervision and administration department under the State Council.

The ports where drugs are allowed to be imported shall be proposed by the drug supervision and administration department under the State Council in conjunction with the General Administration of Customs and submitted to the State Council for approval.

Article 65 If a medical institution imports a small number of drugs due to clinical urgent need, it may import them with the approval of the drug regulatory department under the State Council or the PRC governments of provinces, autonomous regions and municipalities directly under the Central Government authorized by the State Council. Imported drugs shall be used for specific medical purposes in designated medical institutions.

A small number of medicines brought into the country for personal use shall be handled in accordance with relevant state regulations.

Article 66 The import and export of narcotic drugs and psychotropic drugs within the scope prescribed by the state shall hold an import permit and an export permit issued by the drug regulatory department under the State Council.

Article 67 It is forbidden to import drugs with inaccurate curative effects, serious adverse reactions or endangering human health for other reasons.

Article 68 The drug supervision and administration department of the State Council shall designate a drug inspection institution to inspect the following drugs before they are sold or imported; Those that have not been inspected or fail to pass the inspection shall not be sold or imported:

(1) Drugs sold in China for the first time;

(2) Biological products prescribed by the drug regulatory department of the State Council;

(3) Other drugs prescribed by the State Council.

Chapter VI Pharmaceutical Affairs Management of Medical Institutions

Article 69 Medical institutions shall be equipped with pharmacists or other pharmaceutical technicians who have been qualified according to law, responsible for their own drug management, prescription review and deployment, and rational drug use guidance. Non-pharmaceutical technicians are not allowed to directly engage in pharmaceutical technical work.

Article 70 When purchasing drugs, medical institutions shall establish and implement the incoming inspection and acceptance system and verify the drug qualification certificates and other marks; Those that do not meet the prescribed requirements shall not be purchased or used.

Article 71 Medical institutions shall have places, equipment, storage facilities and sanitary environment suitable for the drugs used, formulate and implement the drug storage system, and take necessary measures such as refrigeration, anti-freezing, moisture prevention, insect prevention and rodent prevention to ensure the quality of drugs.

Article 72 Medical institutions shall adhere to the principle of safe, effective, economical and rational use of drugs, follow the guidelines for clinical application of drugs, clinical diagnosis and treatment guidelines, and drug instructions and other rational use of drugs, and review the suitability of doctor’s prescriptions and medication orders.

Drug users other than medical institutions shall abide by the provisions of this Law on the use of drugs by medical institutions.

Article 73 Pharmacists or other pharmaceutical technicians who have passed the qualification according to law shall check the prescription, and the drugs listed in the prescription shall not be changed or substituted without authorization. Prescriptions with contraindications or over-doses should be refused to be formulated; If necessary, it can only be dispensed after correction or re-signature by the prescribing physician.

Article 74 When a medical institution prepares preparations, it shall obtain the approval of the drug supervision and administration department of the PRC government of the province, autonomous region or municipality directly under the Central Government where it is located and obtain the medical institution preparation license. Without a medical institution preparation license, preparations shall not be prepared.

The medical institution’s preparation license shall indicate the validity period, and the license shall be re-examined and issued when it expires.

Article 75 When preparing preparations, medical institutions shall have facilities, management systems, testing instruments and sanitary environment that can ensure the quality of preparations.

The preparation of preparations by medical institutions shall be carried out in accordance with the approved process, and the required raw materials, auxiliary materials and packaging materials shall meet the medicinal requirements.

Article 76 The preparations prepared by medical institutions shall be those that are clinically needed by the unit but are not available on the market, and shall be approved by the drug regulatory department of the PRC government of the province, autonomous region, or municipality directly under the Central Government where it is located; However, unless otherwise stipulated by law on the preparation of traditional Chinese medicine preparations.

Preparations prepared by medical institutions shall be subject to quality inspection in accordance with regulations; Qualified, use in this unit with a doctor’s prescription. With the approval of the drug regulatory department of the State Council or the drug regulatory department of the PRC government of a province, autonomous region or municipality directly under the Central Government, preparations prepared by medical institutions may be adjusted and used among designated medical institutions.

Preparations prepared by medical institutions shall not be sold on the market.

Chapter VII Post-marketing Management of Drugs

Article 77 The holder of a drug marketing license shall formulate a post-marketing risk management plan for drugs, actively carry out post-marketing research on drugs, further confirm the safety, effectiveness and quality controllability of drugs, and strengthen the continuous management of listed drugs.

Article 78 For drugs with conditional approval, the drug marketing license holder shall take corresponding risk management measures and complete relevant research as required within the prescribed time limit; If the research is not completed as required within the time limit or it cannot be proved that the benefits outweigh the risks, the drug supervision and administration department of the State Council shall deal with it according to law until the drug registration certificate is cancelled.

Article 79 Changes in the production process of drugs shall be classified and managed according to their risks and impacts on the safety, effectiveness and quality controllability of drugs. If it is a major change, it shall be approved by the drug regulatory department of the State Council, and other changes shall be filed or reported in accordance with the regulations of the drug regulatory department of the State Council.

The drug marketing license holder shall, in accordance with the regulations of the drug regulatory department of the State Council, comprehensively evaluate and verify the impact of the changes on the safety, effectiveness and quality controllability of the drug.

Article 80 The holder of a drug marketing license shall carry out monitoring of adverse reactions after drug marketing, actively collect, track and analyze information on suspected adverse drug reactions, and take risk control measures in a timely manner for drugs with identified risks.

Article 81 Drug marketing license holders, pharmaceutical manufacturers, pharmaceutical trading enterprises and medical institutions shall frequently inspect the quality, efficacy and adverse reactions of drugs produced, operated and used by their own units. If a suspected adverse reaction is found, it shall be reported to the drug supervision and administration department and the competent health department in a timely manner. Specific measures shall be formulated by the drug supervision and administration department of the State Council in conjunction with the competent health department of the State Council.

For drugs that have been confirmed to have serious adverse reactions, the drug supervision and administration department of the State Council or the drug supervision and administration department of the PRC government of the province, autonomous region or municipality directly under the Central Government shall take emergency control measures such as stopping production, sale and use according to the actual situation, and shall organize the appraisal within five days, and make an administrative decision according to law within fifteen days from the date of the appraisal conclusion.

Article 82 If there are quality problems or other potential safety hazards in drugs, the drug marketing license holder shall immediately stop selling them, inform relevant drug trading enterprises and medical institutions to stop selling and using them, recall the sold drugs, disclose the recall information in a timely manner, immediately stop production when necessary, and report the drug recall and handling to the drug regulatory and administrative departments and health authorities of the PRC governments of provinces, autonomous regions and municipalities directly under the Central Government. Pharmaceutical manufacturers, pharmaceutical trading enterprises and medical institutions shall cooperate.

If the drug marketing license holder should recall the drug according to law but fails to recall the drug, the drug supervision and administration department of the PRC government of the province, autonomous region or municipality directly under the Central Government shall order it to recall the drug.

Article 83 The holder of a drug marketing license shall regularly conduct post-marketing evaluation of the safety, effectiveness and quality controllability of the marketed drugs. When necessary, the drug supervision and administration department of the State Council may order the drug marketing license holder to carry out post-marketing evaluation or directly organize post-marketing evaluation.

After evaluation, the drug registration certificate shall be cancelled for drugs with inaccurate curative effect, serious adverse reactions or endangering human health due to other reasons.

Drugs whose drug registration certificates have been cancelled shall not be produced or imported, sold or used.

Drugs whose drug registration certificates have been cancelled or whose validity period has expired shall be supervised and destroyed by the drug supervision and administration department or other harmless treatment measures shall be taken according to law.

Chapter VIII Drug Prices and Advertisements

Article 84 The state improves the drug procurement management system, monitors drug prices, conducts cost and price investigations, strengthens drug price supervision and inspection, investigates and deals with drug price violations such as price monopoly and price gouging in accordance with the law, and maintains drug price order.

Article 85 For drugs subject to market-adjusted prices in accordance with the law, drug marketing license holders, drug manufacturers, drug dealers and medical institutions shall set prices in accordance with the principles of fairness, reasonableness, honesty and credit, and consistency of quality and price, so as to provide drugs with reasonably priced drugs for drug users.

Pharmaceutical marketing license holders, pharmaceutical manufacturers, pharmaceutical trading enterprises and medical institutions shall abide by the regulations of the drug price administration department of the State Council on drug price management, formulate and indicate the retail price of drugs, and prohibit huge profits, price monopoly and price fraud.

Article 86 Drug marketing license holders, drug manufacturers, drug dealers and medical institutions shall provide the drug price department with information such as the actual purchase and sale price and quantity of their drugs in accordance with the law.

Article 87 Medical institutions shall provide patients with the price list of drugs used, truthfully publish the prices of their commonly used drugs in accordance with regulations and strengthen the management of rational drug use. Specific measures shall be formulated by the competent health department of the State Council.

Article 88 Drug marketing license holders, drug manufacturers, drug dealers and medical institutions are prohibited from giving or accepting kickbacks or other illegitimate benefits in the purchase and sale of drugs.

Drug marketing license holders, pharmaceutical manufacturers, pharmaceutical dealers or agents are prohibited from giving property or other illegitimate benefits to the person in charge of medical institutions, drug purchasers, physicians, pharmacists and other relevant personnel using their drugs in any name. The person in charge of medical institutions, drug purchasing personnel, physicians, pharmacists and other relevant personnel are prohibited from accepting property or other illegitimate benefits from drug marketing license holders, drug manufacturers, drug dealers or agents in any name.

Article 89 Drug advertisements shall be approved by the advertising examination authority determined by the PRC government of the province, autonomous region or municipality directly under the Central Government where the advertiser is located; Without approval, it shall not be published.

Article 90 The contents of drug advertisements shall be true and legal and shall be subject to the drug instructions approved by the drug regulatory department under the State Council, and shall not contain false contents.

Pharmaceutical advertisements shall not contain assertions or guarantees of efficacy and safety; It is not allowed to use the names or images of state organs, scientific research units, academic institutions, trade associations or experts, scholars, doctors, pharmacists, patients, etc. for recommendations or certifications.

Non-drug advertisements shall not include publicity involving drugs.

Article 91 If this Law does not provide for drug prices and advertisements, the Price Law of the People’s Republic of China, the Anti-Monopoly Law of the People’s Republic of China, the Anti-Unfair Competition Law of the People’s Republic of China, and the Advertising Law of the People’s Republic of China shall apply.

Chapter IX Drug Reserve and Supply

Article 92 The state implements a drug reserve system and establishes drug reserves at the central and local levels.

In case of major disasters, epidemics or other emergencies, drugs can be called urgently in accordance with the provisions of the Emergency Response Law of the People’s Republic of China.

Article 93 The state implements the essential drug system, selects an appropriate number of essential drug varieties, strengthens the organization of production and storage, improves the supply capacity of essential drugs, and meets the demand for essential drugs for disease prevention and treatment.

Article 94 The state establishes a drug supply and demand monitoring system, timely collects, summarizes and analyzes the information on the supply and demand of shortage drugs, gives early warning to shortage drugs, and takes countermeasures.

Article 95 The state implements a list management system for shortage drugs. Specific measures shall be formulated by the competent health department of the State Council in conjunction with the drug supervision and administration department of the State Council and other departments.

If the holder of a drug marketing license stops producing drugs in short supply, he shall report to the drug regulatory authority under the State Council or the drug regulatory authority of the PRC government of a province, autonomous region or municipality directly under the Central Government in accordance with regulations.

Article 96 The state encourages the research and production of drugs in short supply and gives priority to the review and approval of drugs in short supply that are urgently needed clinically and new drugs for the prevention and treatment of major infectious diseases and rare diseases.

Article 97 The State Council may restrict or prohibit the export of medicines in short supply. When necessary, the relevant departments of the State Council may take measures such as organizing production, price intervention and expanding imports to ensure the supply of medicines.

Pharmaceutical marketing license holders, pharmaceutical manufacturers, and pharmaceutical trading enterprises shall ensure the production and supply of drugs in accordance with regulations.

Chapter X Supervision and Management

Article 98 It is prohibited to produce (including preparation, the same below), sell and use counterfeit and inferior drugs.

Under any of the following circumstances, it is a counterfeit drug:

(1) The ingredients contained in the drug are inconsistent with the ingredients stipulated in the national drug standards;

(2) pretending to be drugs with non-drugs or pretending to be such drugs with other drugs;

(3) Deteriorated drugs;

(4) The indications or functional indications indicated by the drug exceed the prescribed scope.

One of the following circumstances is inferior medicine:

(1) The content of the drug ingredients does not conform to the national drug standards;

(2) contaminated drugs;

(3) drugs whose validity period is not indicated or changed;

(4) drugs whose product batch number is not indicated or changed;

(5) drugs exceeding the expiry date;

(6) drugs that add preservatives and auxiliary materials without authorization;

(7) other drugs that do not meet the drug standards.

It is prohibited to produce or import drugs without drug approval documents; and to use API, packaging materials and containers without being reviewed and approved in accordance with regulations.

Article 99 The pharmaceutical supervisory and administrative department shall, in accordance with the provisions of the laws and regulations of drug development, production, management and drug use unit use drug supervision and inspection, when necessary, for development, production, management and use of drug products or services of units or individuals to check, the relevant units and individuals shall not refuse and conceal.

The drug regulatory department shall carry out key supervision and inspection of high-risk drugs.

If there is evidence to prove that there may be potential safety hazards, the drug supervision and administration department shall take measures such as warning, interview, rectification within a time limit, and suspension of production, sales, use, and import according to the supervision and inspection situation, and promptly announce the inspection and processing results.

When conducting supervision and inspection, the drug supervision and administration department shall produce supporting documents and shall keep confidential the commercial secrets learned during the supervision and inspection.

Article 100 The drug supervision and administration department may, according to the needs of supervision and administration, conduct spot checks and inspections on the quality of drugs. Spot checks and inspections shall be conducted in accordance with regulations, and no fees shall be charged; Sampling Samples should be purchased. The required expenses shall be paid in accordance with the provisions of the State Council.

For drugs and related materials that have evidence to prove that they may endanger human health, the drug supervision and administration department may seal up and detain them and make an administrative decision within seven days; If a drug needs to be tested, an administrative decision shall be made within fifteen days from the date of issuance of the test report.

Article 101 The drug supervision and administration departments of the State Council and the PRC governments of provinces, autonomous regions and municipalities directly under the Central Government shall regularly announce the results of spot checks on drug quality; If the announcement is improper, it shall be corrected within the scope of the original announcement.

Article 102 If the party concerned has any objection to the drug inspection results, it may apply to the original drug inspection institution or the drug inspection institution set up or designated by the drug supervision and administration department at the next higher level for re-inspection within seven days from the date of receipt of the drug inspection results, or directly apply to the drug inspection institution set up or designated by the drug supervision and administration department under the State Council for re-inspection. The drug inspection institution accepting the re-inspection shall make the re-inspection conclusion within the time prescribed by the drug supervision and administration department of the State Council.

Article 103 The drug supervision and administration department shall inspect the compliance of drug marketing license holders, drug manufacturers, drug dealers, drug non-clinical safety evaluation research institutions, drug clinical trial institutions, etc. with drug manufacturing quality management practices, drug business quality management practices, drug non-clinical research quality management practices, drug clinical trial quality management practices, etc., and supervise their continuous compliance with statutory requirements.

Article 104 The state shall establish a team of professional and specialized drug inspectors. Inspectors should be familiar with drug laws and regulations and have professional knowledge of drugs.

Article 105 The drug supervision and administration department shall establish drug safety credit files of drug marketing license holders, drug manufacturers, drug dealers, drug non-clinical safety evaluation research institutions, drug clinical trial institutions and medical institutions, and record the license issuance, daily supervision and inspection results, investigation and punishment of illegal acts, etc., and announce them to the public according to law and update them in a timely manner; For those with bad credit records, increase the frequency of supervision and inspection, and joint punishment can be implemented in accordance with state regulations.

Article 106 The drug supervision and administration department shall publish its e-mail address and telephone number, accept consultation, complaints and reports, and promptly reply, verify and handle them according to law. For verified reports, the whistle blower shall be rewarded in accordance with relevant regulations.

The drug supervision and administration department shall keep the information of the whistle blower confidential and protect the legitimate rights and interests of the whistle blower. If a whistle blower reports the unit to which he belongs, the unit shall not retaliate against the whistle blower by terminating or changing the labor contract or in other ways.

Article 107 The state implements a unified disclosure system for drug safety information. The overall situation of national drug safety, drug safety risk warning information, major drug safety incidents and their investigation and handling information, and other information determined by the State Council to be uniformly published shall be uniformly published by the drug regulatory department of the State Council. If the impact of drug safety risk warning information and major drug safety incidents and their investigation and handling information is limited to specific areas, they may also be published by the drug supervision and administration department of the PRC government of the relevant province, autonomous region or municipality directly under the Central Government. The above information may not be released without authorization.

The publication of drug safety information should be timely, accurate and comprehensive, and necessary explanations should be made to avoid misleading.

No unit or individual may fabricate or disseminate false drug safety information.

Article 108 PRC governments at or above the county level shall formulate emergency plans for drug safety incidents. Drug marketing license holders, drug manufacturers, drug dealers and medical institutions shall formulate their own drug safety incident handling plans and organize training and emergency drills.

In case of a drug safety incident, the PRC government at or above the county level shall immediately organize and carry out response work in accordance with the emergency plan; The relevant units shall immediately take effective measures to deal with it to prevent the harm from expanding.

Article 109 Where a drug regulatory department fails to timely discover systemic risks of drug safety and fails to timely eliminate potential drug safety risks within the supervision and administration area, the PRC government at the corresponding level or the drug regulatory department of the PRC government at a higher level shall have an interview with the principal person-in-charge.

Where a local PRC government fails to perform its duties of drug safety and fails to eliminate major regional drug safety risks in time, the PRC government at a higher level or the drug regulatory department of the PRC government at a higher level shall have an interview with its main responsible persons.

The interviewed departments and the local PRC government shall take immediate measures to rectify the drug supervision and administration work.

The interview and rectification shall be included in the evaluation and assessment records of drug supervision and administration work by relevant departments and local PRC governments.

Article 110 Local PRC governments and their drug supervisory and administrative departments shall not restrict or exclude drug products from entering the region by the means of drug inspection and examination and approval.

Article 111 The drug supervisory and administrative departments and the professional drug technical institutions established or designated shall not participate in drug production and marketing activities, and shall not recommend, supervise or supervise the sale of drugs in their name.

The staff of the drug supervision and administration department and its established or designated drug professional and technical institutions shall not participate in drug production and business activities.

Article 112 Where the State Council has other special administrative regulations on narcotic drugs, psychotropic drugs, medical toxic drugs, radioactive drugs, pharmaceutical precursor chemicals, etc., such regulations shall prevail.

Article 113 If the drug supervision and administration department find that drug violations are suspected of committing a crime, it shall promptly transfer the case to the public security organ.

For those who do not need to be investigated for criminal responsibility or are exempted from criminal punishment according to law, but should be investigated for administrative responsibility, the public security organ, the PRC procuratorate and the PRC court shall promptly transfer the case to the drug supervision and administration department.

If the public security organ, the PRC procuratorate, and the PRC court request the drug supervision and administration department, the ecological environment department and other departments to provide inspection conclusions, identification opinions, and assistance in harmless treatment of the drugs involved in the case, the relevant departments shall provide them in a timely manner and provide assistance.

Chapter XI Legal Liability

Article 114 Whoever violates the provisions of this Law and constitutes a crime shall be investigated for criminal responsibility according to law.

Article 115 Anyone who produces or sells drugs without a drug production license, drug trading license or pharmaceutical preparation license of a medical institution shall be ordered to close down, the drugs illegally produced and sold and the illegal gains shall be confiscated, and shall be fined 15 times the value and thirty times the value of the drugs (including those sold and unsold, the same below), and the value is less than 100,000 yuan shall be calculated as 100,000 yuan.

Article 116 Those producing or selling counterfeit drugs shall confiscate the illegal production and sale and illegal gains, be ordered to suspend production and business for rectification, and revoke a drug approval certificate and be fined between 15 and 30 times the value of the drugs illegally produced and sold; if the value is less than RMB 100,000; if the circumstances are serious, the drug production license, the drug distribution license or the medical institution shall be revoked, and the drug import shall be prohibited within ten years.

Article 117 Anyone who produces or sells inferior drugs shall confiscate the illegally produced and sold drugs and illegal income, and impose a fine of not less than ten times but not more than twenty times the value of the illegally produced and sold drugs; If the value of illegally produced and wholesaled drugs is less than 100,000 yuan, it shall be calculated as 100,000 yuan; if the value of illegally retailed drugs is less than 10,000 yuan, it shall be calculated as 10,000 yuan; If the circumstances are serious, they shall be ordered to suspend production and business for rectification until the drug approval documents, drug production licenses, drug business licenses or medical institution preparation licenses are revoked.

If the Chinese herbal pieces produced and sold do not meet the drug standards and do not affect the safety and effectiveness, they shall be ordered to make corrections within a time limit and given a warning; A fine of not less than 100,000 yuan but not more than 500,000 yuan may be imposed.

Article 118 Whoever produces or sells counterfeit drugs or inferior drugs, and the circumstances are serious, the legal representative, principal responsible person, directly responsible person in charge and other responsible personnel shall confiscate the income obtained from their own units during the illegal act, and impose a fine of more than 30% but less than three times the income obtained. They shall be prohibited from engaging in drug production and business activities for life and may be detained by the public security organs for more than five days but less than fifteen days.

The raw materials, auxiliary materials, packaging materials and production equipment specially used by producers to produce counterfeit and inferior drugs shall be confiscated.

Article 119 If a drug user uses counterfeit or inferior drugs, it shall be punished in accordance with the provisions on selling counterfeit drugs and retailing inferior drugs; If the circumstances are serious, if the legal representative, the principal person in charge, the directly responsible person in charge and other responsible personnel have the practice certificate of medical and health personnel, the practice certificate shall also be revoked.

Article 120 Those who know or should know that they are counterfeit drugs, inferior drugs or drugs specified in Items 1 to 5 of Paragraph 1 of Article 124 of this Law, and provide them with convenient conditions for storage and transportation, all storage and transportation income shall be confiscated, and a fine of not less than one time but not more than five times the illegal income shall be imposed; If the circumstances are serious, a fine of not less than five times but not more than fifteen times the illegal income shall be imposed; If the illegal income is less than 50,000 yuan, it shall be calculated as 50,000 yuan.

Article 121 The decision on punishment of counterfeit drugs and inferior drugs shall specify the quality inspection conclusion of the drug inspection institution according to law.

Article 122 Anyone who forges, alters, leases, lends or illegally buys and sells licenses or drug approval documents shall have his illegal income confiscated and a fine of not less than one time but not more than five times the illegal income shall be imposed; If the circumstances are serious, a fine of not less than five times but not more than fifteen times the illegal income shall be imposed, the drug production license, drug business license, medical institution preparation license or drug approval certificate shall be revoked, and the legal representative, principal responsible person, directly responsible person in charge and other responsible personnel shall be fined not less than 20,000 yuan but not more than 200,000 yuan. They shall be prohibited from engaging in drug production and business activities within ten years and may be detained by the public security organ for not less than five days but not more than fifteen days; If the illegal income is less than 100,000 yuan, it shall be calculated as 100,000 yuan.

Article 123 If false certificates, data, materials, samples are provided or other means are used to defraud clinical trial licenses, drug production licenses, drug business licenses, medical institution preparation licenses or drug registration licenses, the relevant licenses shall be revoked, and the corresponding application shall not be accepted within ten years, and a fine of not less than 500,000 yuan but not more than 5 million yuan shall be imposed; If the circumstances are serious, the legal representative, the principal person in charge, the directly responsible person in charge and other responsible personnel shall be fined not less than 20,000 yuan but not more than 200,000 yuan, and shall be prohibited from engaging in drug production and business activities within ten years, and may be detained by the public security organ for not less than five days but not more than fifteen days.

Article 124 In violation of the provisions of this Law, Of one of the following acts, Confiscate the drugs illegally produced, imported and sold, the raw materials, auxiliary materials, packaging materials and production equipment specially used for illegal production, Order them to suspend production or business operations for rectification, To concurrently impose a fine of not less than 15 times but not more than 30 times the value of the drugs illegally produced, imported or sold; If the value of the goods is less than 100,000 yuan, By RMB 100,000 yuan; cases of gross violation, Revocation of the drug approval certificate or even revoke the drug production license, drug trading license or drug preparation license of a medical institution, The legal representative, the principal person in charge, the directly responsible person in charge and other responsible persons, To confiscate the income obtained from the unit during the occurrence of the illegal act, And a fine of not less than 30 percent but not more than three times the income earned, Prohibited from drug production and marketing for ten years to life, And may be detained by the public security organ for not less than five days but not more than 15 days:

(1) Producing and importing drugs without obtaining the drug approval certificate;

(2) to produce or import drugs by using the drug approval documents obtained by fraudulent means;

(3) producing drugs using an API that has not been reviewed and approved;

(4) selling drugs without inspection that should be tested;

(5) Produce and sell drugs prohibited by the drug supervision and administration department of the State Council;

(6) Fabricating production and inspection records;

(7) Make major changes in the drug production process without approval.

Anyone who sells the drugs specified in Items 1 to 3 of the preceding paragraph, or who uses the drugs specified in Items 1 to 5 of the preceding paragraph by a drug user, shall be punished in accordance with the provisions of the preceding paragraph; If the circumstances are serious, if the legal representative, principal person in charge, directly responsible person in charge and other responsible personnel of the drug-using unit have a medical and health personnel practice certificate, the practice certificate shall also be revoked.

If a small number of drugs that have been legally marketed abroad are imported without approval, if the circumstances are relatively minor, the punishment may be mitigated or exempted according to law.

Article 125 Anyone who violates the provisions of this Law and commits any of the following acts shall be confiscated from the illegally produced and sold drugs and illegal income, as well as packaging materials and containers, ordered to suspend production and business for rectification, and imposed a fine of not less than 500,000 yuan but not more than 5 million yuan; If the circumstances are serious, the drug approval certificate, drug production license, and drug business license shall be revoked, and the legal representative, principal person in charge, directly responsible person in charge and other responsible personnel shall be fined between 20,000 yuan and 200,000 yuan, and prohibited from engaging in drug production and business activities for ten years or even life:

(1) Carrying out drug clinical trials without approval;

(2) Use unreviewed packaging materials or containers that directly contact drugs to produce drugs, or sell such drugs;

(3) Use unapproved labels and instructions.

Article 126 Unless otherwise stipulated in this Law, drug marketing license holders, drug manufacturers, drug dealers, drug non-clinical safety evaluation research institutions, drug clinical trial institutions, etc. fail to comply with drug production quality management standards, drug business quality management standards, drug non-clinical research quality management standards, drug clinical trial quality management standards, etc. shall be ordered to make corrections within a time limit and given a warning; Those who fail to make corrections within the time limit shall be fined not less than 100,000 yuan but not more than 500,000 yuan; If the circumstances are serious, a fine of not less than 500,000 yuan but not more than 2 million yuan shall be imposed, and production and business shall be ordered to suspend for rectification until the drug approval documents, drug production licenses, drug business licenses, etc. are revoked. Drug non-clinical safety evaluation research institutions, drug clinical trial institutions, etc. shall not carry out drug non-clinical safety evaluation research and drug clinical trials within five years, and the legal representative, principal responsible person, directly responsible person in charge and other responsible personnel shall be confiscated.

Article 127 Whoever violates the provisions of this Law and commits any of the following acts shall be ordered to make corrections within a time limit and given a warning; Those who fail to make corrections within the time limit shall be fined not less than 100,000 yuan but not more than 500,000 yuan:

(1) The bioequivalence test has not been filed;

(2) During the drug clinical trial, safety problems or other risks are found, and the clinical trial sponsor fails to adjust the clinical trial plan in time, suspend or terminate the clinical trial, or fails to report to the drug regulatory authority of the State Council;

(3) Failure to establish and implement a drug traceability system in accordance with regulations;

(4) Failure to submit an annual report in accordance with regulations;

(5) Failure to file or report changes in the drug production process in accordance with regulations;

(6) Failure to formulate a post-marketing risk management plan for drugs;

(7) Failure to carry out post-marketing research or post-marketing evaluation of drugs in accordance with regulations.

Article 128 Except for those that should be punished according to law according to fake drugs or inferior drugs, if the drug packaging is not printed, labeled or attached with instructions according to the regulations, and the labels and instructions fail to indicate relevant information or print with the prescribed marks according to the regulations, it shall be ordered to make corrections and given a warning; If the circumstances are serious, the drug registration certificate shall be revoked.

Article 129 If, in violation of the provisions of this Law, a drug marketing license holder, a drug manufacturer, a drug dealer or a medical institution fails to purchase drugs from a drug marketing license holder or an enterprise with drug production and business qualifications, it shall be ordered to make corrections, the illegally purchased drugs and illegal income shall be confiscated, and a fine of more than two times but less than ten times the value of the illegally purchased drugs shall be imposed; If the circumstances are serious, a fine of not less than ten times but not more than thirty times the value of the goods shall be imposed, and the drug approval certificate, drug production license, drug business license or medical institution practice license shall be revoked; If the value of the goods is less than 50,000 yuan, it shall be calculated as 50,000 yuan.

Article 130 In violation of the provisions of this Law, if a pharmaceutical trading enterprise fails to record the purchase and sale of drugs in accordance with the regulations, fails to correctly explain the usage and dosage of retail drugs, or fails to prepare prescriptions in accordance with the regulations, it shall be ordered to make corrections and given a warning; If the circumstances are serious, the drug business license shall be revoked.

Article 131 In violation of the provisions of this Law, if a third-party platform provider of drug online trading fails to perform the obligations of qualification examination, reporting, and stopping providing online trading platform services, it shall be ordered to make corrections, the illegal income shall be confiscated, and a fine of 200,000 yuan shall be imposed. A fine of not less than RMB 2,000,000 but not more than RMB 2,000,000; If the circumstances are serious, it shall be ordered to suspend business for rectification, and a fine of not less than 2 million yuan but not more than 5 million yuan shall be imposed.

Article 132 Anyone who imports a drug that has obtained a drug registration certificate and fails to file with the drug supervision and administration department at the location of the port where the drug is allowed to be imported in accordance with regulations shall be ordered to make corrections within a time limit and given a warning; If it fails to make corrections within the time limit, the drug registration certificate shall be revoked.

Article 133 If a medical institution violates the provisions of this Law and sells its prepared preparations on the market, it shall be ordered to make corrections, the illegally sold preparations and illegal income shall be confiscated, and a fine of more than two times but less than five times the value of the illegally sold preparations shall be imposed; If the circumstances are serious, a fine of not less than five times but not more than fifteen times the value of the goods shall be imposed; If the value of the goods is less than 50,000 yuan, it shall be calculated as 50,000 yuan.

Article 134 Where a holder of drug marketing authorization fails to carry out ADR monitoring or report suspected adverse drug reactions, he shall be ordered to make corrections within a time limit and given a warning; if he fails to make corrections within the time limit, he shall be ordered to suspend production or business for rectification and imposed a fine of not less than 100,000 yuan but not more than one million yuan.

Where a drug distributor fails to report a suspected adverse drug reaction, it shall be ordered to make corrections within a time limit and given a warning; if it fails to make corrections within the time limit, it shall be ordered to suspend production or business for rectification and shall be imposed a fine of not less than 50,000 yuan but not more than 500,000 yuan.

If a medical institution fails to report a suspected adverse drug reaction, it shall be ordered to make corrections within a time limit and given a warning; failing to correct within the time limit shall be imposed a fine of not less than 50,000 yuan but not more than 500,000 yuan.

Article 135 If the holder of a drug marketing authorization refuses to recall the drug by the drug regulatory authority of the PRC government of the province, autonomous region or municipality directly under the Central Government. If a drug manufacturer, drug trading enterprise or medical institution refuses to cooperate with the recall, a fine of not less than 100,000 yuan but not more than 500,000 yuan shall be imposed.

Article 136 Where the holder of a drug marketing authorization is an overseas enterprise and the enterprise legal person designated in China fails to perform the relevant obligations in accordance with the provisions of this Law, the provisions of this Law on the legal liability of the drug marketing authorization holder shall apply.

Article 137 Whoever commits any of the following acts shall be given heavier punishment within the range of punishment prescribed in this Law:

(1) posing as other drugs with narcotic drugs, psychotropic drugs, toxic drugs for medical use, radioactive drugs and precursor chemicals of drugs, or posing as other drugs as the above-mentioned drugs;

(2) producing and selling counterfeit and inferior medicines that are mainly used by pregnant women and children;

(3) Biological products produced or sold are counterfeit or inferior drugs;

(4) producing and selling fake or inferior drugs, thus causing personal injury consequences;

(5) to produce and sell counterfeit or inferior drugs, and then commit them again after treatment;

(6) Refuse or evade supervision and inspection, forge, destroy or conceal relevant evidence and materials, or use sealed up or seized articles without authorization.

Article 138 Where a drug inspection institution issues a false inspection report, it shall be ordered to make corrections, give a warning and impose a fine of between 200,000 yuan and one million yuan; the person directly in charge and other persons directly responsible shall be demoted, dismissed, confiscated illegal gains and a fine of less than 50,000 yuan; if the circumstances are serious, its inspection qualification shall be revoked. If the inspection results issued by the drug inspection institution are false and losses are caused, it shall bear the corresponding liability for compensation.

Article 139 The administrative penalties prescribed in Articles 115 to 138 of this Law shall be decided by the drug regulatory department of the PRC government at or above the county level according to their respective functions and duties; if the license is revoked or revoked, it shall be decided by the department that originally approved and issued the license.

Article 140 If a drug marketing license holder, a drug manufacturer, a drug trading enterprise or a medical institution employs personnel in violation of the provisions of this Law, the drug supervision and administration department or the competent health department shall order him to dismiss him and impose a fine of not less than 50,000 yuan but not more than 200,000 yuan.

Article 141 If a drug marketing license holder, a drug manufacturer, a drug trading enterprise or a medical institution gives or accepts kickbacks or other illegitimate benefits in the purchase and sale of drugs, and if the drug marketing license holder, a drug manufacturer, a drug trading enterprise or an agent gives property or other illegitimate benefits to the person in charge of the medical institution using its drugs, drug purchasers, doctors, pharmacists and other relevant personnel, the market supervision and administration department shall confiscate the illegal income and impose a fine of not less than 300,000 yuan but not more than 3 million yuan; If the circumstances are serious, the business license of the drug marketing license holder, drug manufacturer, and drug trading enterprise shall be revoked, and the drug supervision and administration department shall revoke the drug approval certificate, drug production license, and drug trading license.

Where a drug marketing authorization holder, drug manufacturer or drug trading enterprise offers bribes to state functionaries in the course of drug development, production or marketing, the legal representative, the principal person in charge, the directly responsible person in charge and other responsible persons shall be prohibited from engaging in drug production and marketing activities for life.

Article 142 Where a drug marketing authorization holder, drug manufacturing enterprise, drug trading enterprise, purchasing personnel and other relevant personnel accept property or other improper benefits from other drug marketing authorization holders, drug manufacturers or drug trading enterprises or agents, the illegal gains shall be confiscated and punished according to law; if the circumstances are serious, the drug production and marketing activities shall be prohibited within five years.

Where the person in charge of a medical institution, drug purchasing personnel, doctors, pharmacists and other relevant personnel accept property or other improper benefits from the drug marketing authorization holder, drug manufacturing enterprise, drug trading enterprise or agent, the competent health department or the unit shall give disciplinary punishment and the illegal gains are confiscated; if the circumstances are serious, the practice certificate shall also be revoked.

Article 143 Whoever, in violation of the provisions of this Law, fabricates or spreads false drug safety information, which constitutes an act against the administration of public security, shall be given an administrative punishment for public security by the public security organ according to law.

Article 144 Where a holder of a drug marketing authorization, a drug manufacturer, a drug trading enterprise or a medical institution, in violation of the provisions of this Law, causes damage to the drug user, he shall be liable for compensation according to law.

Where drug quality is damaged due to quality problems, the victim may claim compensation from the drug marketing authorization holder or the drug manufacturer, or from the drug trading enterprise or the medical institution. Upon receipt of the claim for compensation from the victim, the first responsibility system shall be implemented to pay compensation first; after such compensation, the compensation may be recovered according to law.

Where counterfeit or substandard drugs are still sold or used, the victim or his near relatives may, in addition to requesting compensation for ten times the price or three times the loss; if the additional amount of the compensation is less than 1,000 yuan, it shall be 1,000 yuan.

Article 145 If the drug supervision and administration department or its established or designated drug professional and technical institution participates in drug production and business activities, its superior competent authority shall order it to make corrections and confiscate the illegal income; If the circumstances are serious, the directly responsible person in charge and other directly responsible personnel shall be punished according to law.

If the staff of the drug supervision and administration department or the drug professional and technical institution set up or designated by it participates in drug production and business activities, they shall be punished according to law.

Article 146 If the drug supervision and administration department or its established or designated drug inspection institution illegally collects inspection fees during drug supervision and inspection, the relevant government departments shall order them to refund them, and the directly responsible person in charge and other directly responsible personnel shall be punished according to law; If the circumstances are serious, the inspection qualification shall be revoked.

Article 147 In violation of the provisions of this Law, if the drug supervision and administration department commit any of the following acts, the relevant license shall be revoked, and the person directly responsible in charge and other directly responsible personnel shall be punished according to law:

(1) Approval of drug clinical trials without meeting the conditions;

(2) to issue drug registration certificates to drugs that do not meet the conditions;

(3) Issue a drug production license, a drug business license or a medical institution preparation license to units that do not meet the conditions.

Article 148 If a local PRC government at or above the county level commits any of the following acts in violation of the provisions of this Law, the directly responsible person in charge and other directly responsible personnel shall be given a demerit or a major demerit; If the circumstances are serious, they shall be demoted, dismissed or dismissed:

(1) Concealing, false reporting, delaying or omitting drug safety incidents;

(2) Failure to eliminate regional major drug safety hazards in a timely manner, resulting in particularly major drug safety incidents within the administrative area, or continuous major drug safety incidents;

(3) ineffective performance of duties, resulting in serious adverse effects or heavy losses.

Article 149 In violation of the provisions of this Law, if the drug supervision and administration department commit any of the following acts, the directly responsible person in charge and other directly responsible personnel shall be given a demerit or a major demerit; If the circumstances are serious, they shall be demoted or dismissed; If the circumstances are serious, dismissal shall be given:

(1) Concealing, false reporting, delaying or omitting drug safety incidents;

(2) Failure to promptly investigate and deal with drug safety violations found;

(3) Failure to discover systemic risks of drug safety in a timely manner, or failure to eliminate potential drug safety hazards in the supervision and management area in a timely manner, causing serious impacts;

(4) Other failure to perform drug supervision and administration duties, resulting in serious adverse effects or major losses.

Article 150 Drug supervision and administration personnel who abuse their powers, engage in malpractices for personal gain, or neglect their duties shall be punished according to law.

If there is dereliction of duty or dereliction of duty in the investigation and punishment of illegal acts of counterfeit drugs and inferior drugs, the person in charge directly responsible for the drug supervision and administration department and other directly responsible personnel shall be severely punished according to law.

Article 151 The value of goods specified in this chapter shall be calculated based on the price of illegally produced and sold drugs; If there is no price tag, it shall be calculated according to the market price of similar drugs.

Chapter XII Supplementary Provisions

Article 152 The management of the planting, collection and feeding of Chinese herbal medicines shall be carried out in accordance with the provisions of relevant laws and regulations.

Article 153 The measures for the administration of regional folk traditional medicinal materials shall be formulated by the drug supervision and administration department of the State Council in conjunction with the competent department of traditional Chinese medicine of the State Council.

Article 154 The specific measures for the implementation of this Law by the Chinese People’s Liberation Army and the Chinese People’s Armed Police Force shall be formulated by the State Council and the Central Military Commission in accordance with this Law.

Article 155 This Law shall come into force on December 1, 2019.