The Measures for the Administration of Drug Registration, which was reviewed and adopted at the first executive meeting of the State Administration for Market Regulation in 2020 on January 15, 2020, is hereby promulgated and shall come into force on July 1, 2020.

Chapter I General Provisions

Article 1 In order to standardize drug registration behavior and ensure the safety, effectiveness and quality controllability of drugs, These Measures are formulated in accordance with the Drug Administration Law of the Peoples Republic of China (hereinafter referred to as the Drug Administration Law), the Traditional Chinese Medicine Law of the Peoples Republic of China, the Vaccine Administration Law of the Peoples Republic of China (hereinafter referred to as the Vaccine Administration Law), the Administrative Licensing Law of the Peoples Republic of China, the Implementation Regulations of the Drug Administration Law of the Peoples Republic of China and other laws and administrative regulations.

Article 2 These Measures shall apply to drug research, registration, supervision and administration activities for the purpose of drug marketing within the territory of the Peoples Republic of China.

Article 3 Drug registration refers to the activities in which the drug registration applicant (hereinafter referred to as the applicant) submits applications for drug clinical trials, drug marketing authorization, re-registration, etc. and supplementary applications in accordance with legal procedures and relevant requirements, and the drug supervision and administration department reviews the safety, effectiveness and quality controllability based on laws, regulations and existing scientific knowledge, and decides whether to agree to its application.

After obtaining the drug registration certificate, the applicant is the holder of the drug marketing authorization (hereinafter referred to as the holder).

Article 4 Drug registration shall be classified and registered according to traditional Chinese medicines, chemical drugs and biological products.

Traditional Chinese medicine registration is classified according to innovative traditional Chinese medicine drugs, improved new traditional Chinese medicine drugs, ancient classic famous traditional Chinese medicine compound preparations, and medicines with the same name and the same prescription.

Chemical drug registration is classified according to innovative chemical drugs, improved new chemical drugs, generic drugs, etc.

Registration of biological products is classified according to innovative biological products, improved new biological products, and marketed biological products (including biosimilar drugs).

The detailed classification of drugs such as traditional Chinese medicines, chemical drugs and biological products and the corresponding application materials requirements shall be organized and formulated by the National Medical Products Administration according to the product characteristics, innovation degree and review management needs of registered drugs, and announced to the public.

The registration application for overseas production of drugs shall be implemented in accordance with the detailed classification of drugs and the corresponding application materials requirements.

Article 5 The National Medical Products Administration is in charge of the national drug registration management and is responsible for establishing the drug registration management system and system, formulating drug registration management norms, organizing drug registration review and approval and related supervision and management work in accordance with the law. The Drug Evaluation Center of the National Medical Products Administration (hereinafter referred to as the Drug Evaluation Center) is responsible for the review of drug clinical trial applications, drug marketing authorization applications, supplementary applications and re-registration applications for overseas production drugs. China Institute of Food and Drug Control (hereinafter referred to as China Inspection Institute), State Pharmacopoeia Commission (hereinafter referred to as Pharmacopoeia Commission), National Medical Products Administration Food and Drug Examination and Inspection Center (hereinafter referred to as Drug Verification Center), National Medical Products Administration Drug Evaluation Center (hereinafter referred to as Drug Evaluation Center), National Medical Products Administration Administrative Matters Acceptance Service and Complaint Reporting Center, National Medical Products Administration Information Center (hereinafter referred to as Information Center) and other drug professional and technical institutions.

Article 6 The drug supervision and administration departments of provinces, autonomous regions and municipalities directly under the Central Government shall be responsible for the following drug registration-related management within their respective administrative areas:

(1) The acceptance, examination and approval of applications for re-registration of drugs produced in China;

(2) Management of filing and reporting matters of post-marketing changes of drugs;

(3) Organize the daily supervision of drug non-clinical safety evaluation research institutions and drug clinical trial institutions and the investigation and punishment of illegal acts;

(4) Participate in drug registration verification and inspection organized by the National Medical Products Administration;

(5) Matters related to drug registration entrusted by the State Medical Products Administration.

The drug professional and technical institutions set up or designated by the drug supervision and administration departments of provinces, autonomous regions and municipalities directly under the Central Government shall undertake the review, inspection, verification, monitoring and evaluation required for the implementation of drug supervision and administration in accordance with the law.

Article 7 The management of drug registration follows the principles of openness, fairness and impartiality, is guided by clinical value, encourages research and creation of new drugs, and actively promotes the development of generic drugs.

The National Medical Products Administration continues to promote the reform of the review and approval system, optimize the review and approval procedures, improve the efficiency of review and approval, and establish a drug registration management system led by review and supported by inspection, verification, monitoring and evaluation.

Chapter II Basic Systems and Requirements

Article 8 When engaged in drug development and drug registration activities, relevant laws, regulations, rules, standards and norms shall be abided by; If other evaluation methods and technologies are adopted with reference to relevant technical guidelines, their scientificity and applicability shall be proved; It should be ensured that the information in the whole process is true, accurate, complete and traceable.

Drugs shall conform to the national drug standards and drug quality standards approved by the State Medical Products Administration. The drug quality standards approved by the National Medical Products Administration are drug registration standards. Drug registration standards shall comply with the general technical requirements of the Pharmacopoeia of the Peoples Republic of China and shall not be lower than the provisions of the Pharmacopoeia of the Peoples Republic of China. If the testing items or indicators of the registered varieties are not applicable to the Pharmacopoeia of the Peoples Republic of China, the applicant shall provide sufficient supporting data.

Professional and technical institutions such as drug evaluation centers shall formulate technical guiding principles and procedures according to scientific progress, actual industry development and the needs of drug supervision and administration and announce them to the public.

Article 9 The applicant shall be an enterprise or drug research and development institution that can bear corresponding legal responsibilities. Overseas applicants shall designate enterprise legal persons within China to handle relevant drug registration matters.

Article 10 Before applying for drug registration, the applicant shall complete pharmaceutical, pharmaceutical toxicology and drug clinical trials. Non-clinical safety evaluation studies shall be conducted in institutions certified by non-clinical studies and comply with the regulations. Drug clinical trials shall be approved, in which bioequivalence trials shall be put on record; drug clinical trials shall be carried out in drug clinical trial institutions that meet relevant regulations, and the quality control standards of drug clinical trials shall be observed.

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

If overseas research data and data are used to support drug registration, the source, research institution or laboratory conditions, quality system requirements and other management conditions shall conform to the prevailing principles of the International Coordination Committee on Technical Requirements for Drug Registration for Human Use and meet the relevant requirements of drug registration administration in China.

Article 11 If the matters or contents stated in the original drug registration approval certificate and its annexes are changed, the applicant shall, in accordance with the regulations and with reference to the relevant technical guidelines, fully study and verify the drug change, fully evaluate the possible impact of the change on the safety, effectiveness and quality controllability of the drug, and submit a supplementary application, filing or report in accordance with the change procedures.

Article 12 The validity period of the drug registration certificate is five years. During the validity period of the drug registration certificate, the holder shall continue to ensure the safety, effectiveness and quality controllability of the marketed drug, and apply for drug re-registration six months before the expiration of the validity period.

Article 13 The National Medical Products Administration shall establish an accelerated drug marketing registration system to support clinical value-oriented drug innovation. For eligible drug registration applications, applicants can apply for breakthrough therapeutic drugs, conditional approval, priority review and approval, and special approval procedures. In the process of drug development and registration, the drug supervision and administration department and its professional and technical institutions provide necessary technical guidance, communication, priority allocation of resources, shortening the review time limit and other policies and technical support.

Article 14 The National Medical Products Administration shall establish a related review and approval system for chemical raw materials, excipients and packaging materials and containers in direct contact with drugs. When approving pharmaceutical preparations, chemical raw materials should be reviewed and approved together, and relevant excipients, packaging materials and containers in direct contact with drugs should be reviewed together. The Drug Evaluation Center establishes an information registration platform for chemical raw materials, excipients and packaging materials and containers in direct contact with drugs, publicizes relevant registration information for relevant applicants or holders to choose, and makes relevant review when applying for registration of relevant pharmaceutical preparations.

Article 15 Prescription drugs and over-the-counter drugs shall be subject to classified registration and conversion management. According to the characteristics of over-the-counter drugs, the Center for Drug Evaluation formulates technical guidelines and procedures related to the marketing and registration of over-the-counter drugs and announces them to the public. The Drug Evaluation Center formulates relevant technical requirements and procedures for post-marketing conversion of prescription drugs and over-the-counter drugs and announces them to the public.

Article 16 Applicants may communicate with professional and technical institutions such as the Drug Evaluation Center on major issues at key stages such as before the application for drug clinical trials, during the drug clinical trials, and before the application for drug marketing authorization. During the drug registration process, professional and technical institutions such as the Drug Evaluation Center can organize communication with the applicant according to the work needs.

The procedures, requirements and time limits for communication shall be formulated by professional and technical institutions such as the Drug Evaluation Center according to their functions and announced to the public.

Article 17 Drug Evaluation Center and other professional and technical institutions shall establish an expert consultation system according to the needs of their work, establish an expert advisory committee, listen to expert opinions on major issues in the process of review, verification, inspection, generic name approval, etc., and give full play to the technical support role of experts.

Article 18 The National Medical Products Administration shall establish a catalog of chemical drugs that have been newly approved for marketing and have passed the consistency evaluation of the quality and efficacy of generic drugs, stating the drug name, active ingredient, dosage form, specification, whether it is a reference preparation, holder and other relevant information, update and disclose to the public in a timely manner. The procedures and requirements for the collection of chemical drug catalogs shall be formulated by the Drug Evaluation Center and announced to the public.

Article 19 National Medical Products Administration supports the inheritance and innovation of traditional Chinese medicine, establishes and improves the registration management system and technical evaluation system that conform to the characteristics of traditional Chinese medicine, encourages the use of modern science and technology and traditional research methods to develop traditional Chinese medicine, strengthens the quality control of traditional Chinese medicine, and improves the clinical trial level of traditional Chinese medicine.

When applying for registration of traditional Chinese medicine, the applicant should conduct clinical value and resource evaluation, highlight the clinical value as the orientation, and promote the sustainable utilization of resources.

Chapter III Drug Marketing Registration

Section I Drug Clinical Trials

Article 20 The term “drug clinical trial” as mentioned in these Measures refers to drug research carried out in humans for the purpose of drug marketing registration to determine the safety and effectiveness of drugs.

Article 21 Drug clinical trials are divided into phase I clinical trials, phase II clinical trials, phase III clinical trials, phase IV clinical trials and bioequivalence trials. According to the drug characteristics and research purpose, the research content includes clinical pharmacology study, exploration clinical trial, confirmatory clinical trial and post-marketing study.

Article 22 drug clinical trials shall be carried out in drug clinical trial institutions that have the corresponding conditions and are filed in accordance with regulations. Among them, vaccine clinical trials should be implemented or organized by tertiary medical institutions or disease prevention and control institutions at or above the provincial level that meet the conditions prescribed by the National Medical Products Administration and the National Health Commission.

Article 23 After the applicant completes the pharmaceutical, pharmacological and toxicological studies supporting drug clinical trials, if the applicant applies for drug clinical trials, he shall submit relevant research materials in accordance with the requirements of the application materials. After formal examination, if the application materials meet the requirements, it shall be accepted. The Drug Evaluation Center shall organize pharmacy, medical and other technical personnel to review the accepted drug clinical trial applications. For drug clinical trial applications, it shall decide whether to agree to carry out within 60 days from the date of acceptance, and notify the applicant of the examination and approval results through the website of the Drug Evaluation Center; If notification is not made within the time limit, it shall be deemed as consent, and the applicant may carry out drug clinical trials according to the submitted plan.

The applicant who is approved to conduct drug clinical trials is the drug clinical trial sponsor (hereinafter referred to as the sponsor).

Article 24 If the applicant intends to carry out a bioequivalence test, it shall, as required, complete the bioequivalence test filing on the website of the Center for Drug Evaluation, and carry out relevant research work in accordance with the filed plan.

Article 25 Drug clinical trials shall be approved by the ethics committee.

The management of drugs for clinical trials shall comply with the relevant requirements of the Good Management Standards for Drug Clinical Trials.

Article 26 If it is approved to carry out drug clinical trials, the sponsor shall formulate the corresponding drug clinical trial plan before carrying out the follow-up staged drug clinical trials, which shall be carried out after review and approval by the ethics committee, and submit the corresponding drug clinical trial plan and supporting information on the website of the Drug Evaluation Center.

Article 27 If a drug approved to carry out drug clinical trial intends to increase indications (or functional indications) or increase the combination of drugs with other drugs, the applicant shall submit a new drug clinical trial application, and the new drug clinical trial can only be carried out after approval. Drug clinical trial.

If the drug approved for marketing needs to carry out drug clinical trials for increased indications (or functional indications), a new drug clinical trial application shall be submitted.

Article 28 Sponsors shall regularly submit safety update reports during research and development on the website of the Center for Drug Evaluation. The safety update report during the research and development period should be submitted once a year, within two months after every one year after the drug clinical trial is approved. The Center for Drug Evaluation may require the sponsor to adjust the reporting cycle according to the review situation.

For suspicious and unexpected serious adverse reactions and other potential serious safety risk information during drug clinical trials, the sponsor shall promptly report to the Center for Drug Evaluation in accordance with relevant requirements. According to the severity of safety risks, the sponsor may be required to take measures to strengthen risk control, such as adjusting the drug clinical trial protocol, informed consent form, investigator manual, etc., and if necessary, the sponsor may be required to suspend or terminate the drug clinical trial.

Specific requirements for safety update reports during research and development are formulated and published by the Center for Drug Evaluation.

Article 29 During the drug clinical trial, if the drug clinical trial plan changes, non-clinical or pharmaceutical changes or new discoveries occur, the sponsor shall fully evaluate the impact on the safety of subjects in accordance with regulations and with reference to relevant technical guidelines.

If the sponsor assesses that it does not affect the safety of subjects, it can be directly implemented and reported in the safety update report during development. If it may increase the safety risk of the subject, a supplementary application should be made. For the supplementary application, it shall decide whether to agree or not within 60 days from the date of acceptance and notify the applicant of the examination and approval results through the website of the Drug Evaluation Center; Failure to give notice within the time limit shall be deemed as consent.

If the sponsor changes, the sponsor after the change shall bear the relevant responsibilities and obligations of the drug clinical trial.

Article 30 During the clinical trial of a drug, if safety problems or other risks are found, the sponsor shall promptly adjust the clinical trial plan, suspend or terminate the clinical trial, and report to the Center for Drug Evaluation.

Under any of the following circumstances, the sponsor may be required to adjust the drug clinical trial plan, suspend or terminate the drug clinical trial:

(1) The ethics committee fails to perform its duties;

(2) cannot effectively guarantee the safety of subjects;

(3) The sponsor fails to submit the safety update report during research and development as required;

(4) The sponsor fails to promptly deal with and report suspicious and unexpected serious adverse reactions;

(5) There is evidence to prove that the study drug is ineffective;

(6) Quality problems of drugs used for clinical trials;

(7) fraud in the process of drug clinical trials;

(8) other violations of drug clinical trial quality management standards.

When a large-scale and unexpected serious adverse reaction occurs in a drug clinical trial, or there is evidence to prove that there are serious quality problems in the drug used for clinical trials, the sponsor and the drug clinical trial institution shall immediately stop the drug clinical trial. The drug supervision and administration department may order to adjust the clinical trial plan, suspend or terminate drug clinical trials according to its duties.

Article 31 After the drug clinical trial is ordered to be suspended, if the sponsor intends to continue to carry out the drug clinical trial, it shall submit a supplementary application for resuming the drug clinical trial after the rectification is completed, and the drug clinical trial can only be continued after examination and approval. If the drug clinical trial has been suspended for three years and the drug clinical trial has not been applied for and approved to resume the drug clinical trial, the drug clinical trial license will become invalid automatically.

After the drug clinical trial is terminated, if it is planned to continue the drug clinical trial, the drug clinical trial application shall be re-submitted.

Article 32 Clinical trials of drugs shall be carried out within three years after approval. If no subject has signed an informed consent form within three years from the date of approval of the drug clinical trial application, the drug clinical trial license will become invalid automatically. If it is still necessary to implement drug clinical trials, it should be re-applied.

Article 33 The sponsor shall register the drug clinical trial plan and other information on the drug clinical trial registration and information disclosure platform before carrying out drug clinical trials. During the drug clinical trial, the sponsor shall continuously update the registration information and register the drug clinical trial results and other information after the completion of the drug clinical trial. The registration information is publicized on the platform, and the sponsor is responsible for the authenticity of the registration information of drug clinical trials.

The specific requirements for drug clinical trial registration and information disclosure shall be formulated and published by the Center for Drug Evaluation.

Section II Drug Marketing Authorization

Article 34 The applicant shall submit an application for drug marketing authorization and submit relevant research materials in accordance with the requirements of the application materials after completing the research on pharmacy, pharmacology and toxicology and drug clinical trials supporting drug marketing registration, determining quality standards, completing commercial-scale production process verification, and making preparations for drug registration verification and inspection. After formal examination of the application materials, if they meet the requirements, they will be accepted.

Article 35 If generic drugs, in vitro diagnostic reagents managed according to drugs, and other qualified circumstances, after evaluation by the applicant, it is considered that it is unnecessary or impossible to carry out drug clinical trials and meet the conditions for exempted drug clinical trials, the applicant may directly apply for drug marketing license. The technical guidelines and relevant specific requirements for exempted clinical trials of drugs shall be formulated and published by the Center for Drug Evaluation.

Generic drugs should be consistent in quality and efficacy with reference preparations. The applicant shall select reasonable reference preparation with reference to the relevant technical guidelines.

Article 36 If one of the following circumstances is met, an application for marketing authorization of over-the-counter drugs may be directly submitted:

(1) Drugs with over-the-counter drugs with the same active ingredients, indications (or functional indications), dosage forms, and specifications already on the market in China;

(2) Drugs that have changed dosage form or specification of over-the-counter drugs determined by the State Medical Products Administration, but do not change indications (or functional indications), dosage and route of administration;

(3) New compound preparations composed of the active ingredients of over-the-counter drugs determined by the State Medical Products Administration;

(4) Other situations of direct application for marketing authorization of over-the-counter drugs.

Article 37 If the generic name of the drug to be used in the declared drug is not included in the national drug standard or drug registration standard, the applicant shall submit an application for approval of the generic name at the same time when submitting the application for drug marketing authorization. After the application for drug marketing authorization is accepted, the relevant information of generic name approval will be transferred to the Pharmacopoeia Commission, and the Pharmacopoeia Commission will feed back to the Drug Evaluation Center after approval.

The generic name of the drug to be used in the declared drug has been included in the national drug standard or drug registration standard. If the Drug Evaluation Center considers it necessary to approve the generic name of the drug during the review process, it shall notify the Pharmacopoeia Commission to approve the generic name and provide relevant information. After approval, the Pharmacopoeia Commission will feed back to the Drug Evaluation Center.

When approving the generic name of a drug, the Pharmacopoeia Commission shall communicate well with the applicant and inform the applicant of the approval result.

Article 38 The Drug Evaluation Center shall organize pharmaceutical, medical and other technical personnel to review the accepted drug marketing license applications as required.

During the review process, drug registration verification and inspection are initiated based on risks, and relevant technical institutions shall complete the verification and inspection within the prescribed time limit.

The Drug Evaluation Center shall conduct a comprehensive review of the safety, effectiveness and quality controllability of drugs based on the drug registration application materials, verification results and inspection results, and over-the-counter drugs shall also be transferred to the Drug Evaluation Center for over-the-counter drug suitability review.

Article 39 If the conclusion of the comprehensive review is passed, the drug shall be approved for marketing and a drug registration certificate shall be issued. If the comprehensive review conclusion fails, a decision of disapproval shall be made. The drug registration certificate specifies the drug approval number, holder, manufacturer and other information. The drug registration certificate of over-the-counter drugs shall also indicate the category of over-the-counter drugs.

The approved drug production process, quality standards, instructions and labels shall be issued to the applicant as an annex to the drug registration certificate, and if necessary, the requirements for post-marketing research of the drug shall also be attached. The above information is included in the drug variety file and updated in a timely manner according to the post-marketing changes.

After the drug is approved for marketing, the holder shall produce the drug in accordance with the production process and quality standards approved by the National Medical Products Administration and refine and implement it in accordance with the requirements of drug manufacturing quality management practices.

Article 40 During the review of a drug marketing license application, if a major change occurs that may affect the safety, effectiveness and quality controllability of the drug, the applicant shall withdraw the original registration application and re-apply after supplementary research.

If the name changes of the applicant, the name change of the registered address, etc. does not involve the technical review content, it shall promptly inform the Drug Evaluation Center in writing and submit relevant supporting materials.

Section III Related Review and Approval

Article 41 When reviewing the application for registration of pharmaceutical preparations, the Drug Evaluation Center shall conduct related reviews on the chemical raw materials, excipients and packaging materials and containers that are in direct contact with drugs selected for pharmaceutical preparations.

Manufacturers of chemical raw materials, excipients and packaging materials and containers in direct contact with drugs shall register product information and research materials on the registration platform of chemical raw materials, excipients and packaging materials and containers in direct contact with drugs in accordance with the requirements of the relevant review and approval system. The Drug Evaluation Center publicizes basic information such as registration number, product name, enterprise name, and production address to the public for the selection of pharmaceutical preparation registration applicants.

Article 42 When applying for drug registration, an applicant for a pharmaceutical preparation may directly select registered chemical raw materials, excipients and packaging materials and containers that are in direct contact with the drug; If unregistered chemical raw materials, excipients and packaging materials and containers in direct contact with drugs are selected, relevant research data shall be declared together with the application for registration of pharmaceutical preparations.

Article 43 When reviewing the application for registration of pharmaceutical preparations, the Drug Evaluation Center shall conduct related evaluation on the chemical raw materials, excipients and packaging materials and containers that directly contact drugs selected for pharmaceutical preparations. If supplementary information is needed, it shall require the applicant for pharmaceutical preparations or the registration enterprise of chemical raw materials, excipients and packaging materials and containers that directly contact drugs to supplement information according to the supplementary information procedure, and may propose extended inspection of chemical raw materials, excipients and packaging materials and containers based on risks.

Those who imitate chemical raw materials used in domestic marketed drugs may apply for separate review and approval.

Article 44 If the chemical raw materials, excipients and packaging materials and containers in direct contact with drugs have passed the related review or passed the separate review and approval, the drug evaluation center shall update the registration status identification of the chemical raw materials, excipients and packaging materials in direct contact with drugs and the container registration platform and publicize relevant information to the public. Among them, chemical raw materials are issued with the approval notice of chemical raw materials and the approved production process, quality standards and labels at the same time, and the registration number is specified in the approval notice of chemical raw materials; If it is not approved, a notice of disapproval of chemical raw materials will be issued.

If the relevant review and approval is not passed, the registration status of chemical raw materials, excipients and packaging materials and container products that are in direct contact with drugs will remain unchanged, and the application for relevant pharmaceutical preparations will not be approved.

Section IV Drug Registration Verification

Article 45 Drug registration verification refers to the verification activities carried out at the development site and production site in order to verify the authenticity and consistency of the application materials and the commercial production conditions of drugs on the market, and to check the compliance and data reliability of drug development, as well as the extended inspection activities carried out by chemical raw materials, excipients, packaging materials and containers manufacturers, suppliers or other entrusted institutions involved in drug registration applications when necessary.

The principles, procedures, time limits and requirements for the initiation of drug registration verification shall be formulated and published by the Center for Drug Evaluation; The principles, procedures, time limits and requirements for the implementation of drug registration verification shall be formulated and published by the Drug Verification Center.

Article 46 The Drug Evaluation Center decides whether to carry out on-site verification of drug registration and development based on risks based on the degree of drug innovation and the previous verification of drug research institutions.

If the Drug Evaluation Center decides to start the on-site verification of drug registration and development, it shall notify the Drug Evaluation Center to organize and implement the verification during the review period and inform the applicant at the same time. The drug verification center shall complete the on-site verification within the prescribed time limit, and feedback on the verification situation, verification conclusion and other relevant materials to the drug evaluation center for comprehensive review.

Article 47 The Center for Drug Evaluation shall decide whether to initiate on-site verification of drug registration and production based on risks based on factors such as the varieties, processes, facilities, and previous verification status declared for registration.

For innovative drugs, improved new drugs and biological products, on-site inspections of drug registration and production and pre-marketing drug manufacturing quality management practices should be carried out.

For generic drugs, etc., according to whether the drug production license of the corresponding production scope has been obtained, and the same dosage form has been listed, etc., on-site inspection of drug registration and production and pre-marketing drug production quality management practice inspection will be carried out based on risks.

Article 48 After the drug registration application is accepted, the drug evaluation center shall conduct a preliminary examination within 40 days after acceptance. If the drug registration production site verification is required, the drug verification center shall be notified to organize the verification, provide the relevant materials required for verification, and at the same time inform the applicant and the drug supervision and administration department of the province, autonomous region or municipality directly under the Central Government where the applicant or manufacturing enterprise is located. In principle, the drug verification center shall complete the verification work 40 days before the expiration of the review time limit, and feedback the verification status, verification results and other relevant materials to the drug evaluation center.

If the inspection of drug production quality management practices before marketing is required, the drug verification center shall coordinate the drug supervision and administration departments of relevant provinces, autonomous regions and municipalities directly under the Central Government to implement the simultaneous inspection of drug registration and production site. The management requirements for the inspection of drug production quality management practices before marketing shall be implemented in accordance with the relevant provisions of the Drug Production Supervision and Administration Measures.

The applicant shall accept the verification within the prescribed time limit.

Article 49 During the review process, the Drug Evaluation Center finds that the authenticity of the application materials is doubtful or there are clear clues to report, etc., and requires on-site inspection and verification, it shall start the cause-based inspection and conduct sampling inspection if necessary.

Article 50 When applying for a drug marketing license, the applicant and the production enterprise shall have obtained the corresponding drug production license.

Section V Drug Registration Inspection

Article 51 Drug registration inspection, including standard review and sample inspection. Standard review refers to the laboratory evaluation of the scientificity of the items set in the drug standards declared by the applicant, the feasibility of inspection methods, and the rationality of quality control indicators. Sample inspection refers to the laboratory inspection of samples in accordance with the drug quality standards declared by the applicant or approved by the Drug Evaluation Center.

The principles, procedures, time limits and other requirements for the start of drug registration inspection shall be formulated and published by the Center for Drug Evaluation. Before the drug registration application is accepted, the specific working procedures and requirements for drug registration inspection, as well as the technical requirements and specifications for drug registration inspection, shall be formulated and published by the Central Inspection Institute.

Article 52 If the inspection items and inspection methods used for drugs of the same kind included in the national drug standards are consistent, the standard review may not be carried out, but only sample inspection may be carried out. In other cases, standard review and sample inspection shall be carried out.

Article 53 The Central Inspection Institute or the drug inspection institution designated by the State Medical Products Administration shall undertake the following drug registration inspections:

(1) Innovative drugs;

(2) Improved new drugs (except traditional Chinese medicines);

(3) Biological products, radioactive drugs and in vitro diagnostic reagents managed according to drugs;

(4) Other drugs prescribed by the State Medical Products Administration.

The drug registration inspection of overseas produced drugs shall be carried out by the port drug inspection institutions organized by the China Inspection and Quarantine Institute.

The registration inspection of other drugs shall be undertaken by the provincial drug inspection agency where the applicant or the manufacturing enterprise is located.

Article 54 After the applicant has completed the pharmaceutical-related research supporting the marketing of drugs, determined the quality standards, and completed the commercial-scale production process verification, he may submit a drug registration inspection to the Central Inspection Institute or the drug supervision and administration department of the province, autonomous region, or municipality directly under the Central Government before accepting the drug registration application; If the applicant fails to submit a drug registration inspection before the drug registration application is accepted, the drug registration inspection shall be initiated by the drug evaluation center within 40 days after the drug registration application is accepted. In principle, the applicant can only submit one drug registration test before the drug registration application is accepted, and may not submit drug registration tests to multiple drug inspection agencies at the same time.

The drug registration inspection materials submitted by the applicant shall be consistent with the corresponding contents of the drug registration application materials, and the drug inspection institutions, samples and materials shall not be changed during the drug registration inspection process.

Article 55 For the registration application of drugs produced in China, if the applicant submits drug registration inspection before the drug registration application is accepted, it shall apply to the drug supervision and administration department of the relevant province, autonomous region and municipality directly under the Central Government for sampling, and the drug supervision and administration department of the province, autonomous region and municipality directly under the Central Government shall organize sampling and seal it, and the applicant shall send the sampling sheet, samples, inspection required materials and reference materials to the corresponding drug inspection agency.

For the registration application of overseas production of drugs, if the applicant submits drug registration inspection before the drug registration application is accepted, the applicant shall take samples according to the prescribed requirements, and send the samples, materials required for inspection and reference materials to the Central Inspection Institute.

Article 56 If an application for registration of drugs produced in China requires drug registration inspection after the drug registration application is accepted, the Drug Evaluation Center shall issue a notice of drug registration inspection to the drug inspection agency and the applicant within 40 days after acceptance. The applicant applies for sampling to the drug regulatory authorities of the relevant provinces, autonomous regions, and municipalities directly under the Central Government, and the drug regulatory authorities of the provinces, autonomous regions, and municipalities directly under the Central Government shall organize sampling and seal it. The applicant shall submit the sampling sheet, samples, inspection required materials and reference materials within the prescribed time limit to the corresponding drug inspection agency.

For the registration application of overseas production of drugs, if drug registration inspection is required after the drug registration application is accepted, the applicant shall take samples according to the prescribed requirements, and send the samples, materials required for inspection and reference materials to the Central Inspection Institute.

Article 57 The drug inspection agency shall review the inspection samples and materials submitted by the applicant within five days, make a decision on whether to accept them, and inform the drug evaluation center at the same time. If it is necessary to make corrections, the applicant shall be informed at one time.

In principle, the drug inspection agency shall feedback the standard review opinions and inspection reports to the drug evaluation center 40 days before the expiration of the review time limit.

Article 58 In the process of drug review and verification, if it is found that the authenticity of the application materials is doubtful or there are clear clues to report, or it is considered necessary to conduct sample inspection, samples may be taken for sample inspection.

During the review process, the Center for Drug Evaluation can propose a single review of quality standards based on risks.

Chapter IV Accelerated Marketing Registration Procedures for Drugs

Section I Breakthrough Therapy Drug Procedures

Article 59 During the clinical trial of a drug, it is used to prevent and treat diseases that seriously endanger life or seriously affect the quality of life, and there is no effective prevention, and treatment means or there is sufficient evidence to show that it has obvious clinical advantages compared with the existing treatment means. For innovative drugs or improved new drugs, the applicant may apply for the application of breakthrough therapeutic drug procedures.

Article 60 If an application is applied to the breakthrough therapeutic drug procedure, the applicant shall apply to the Center for Drug Evaluation. If the conditions are met, the Drug Evaluation Center will be included in the breakthrough therapeutic drug program after publicity in accordance with the procedures.

Article 61 The following policy support shall be given to clinical trials of drugs included in the breakthrough therapeutic drug program:

(1) The applicant may submit an application for communication and exchange to the Drug Evaluation Center at the critical stage of drug clinical trials, and the Drug Evaluation Center arranges reviewers to communicate and exchange;

(2) The applicant may submit the phased research data to the Drug Evaluation Center, and the Drug Evaluation Center, based on the existing research data, puts forward opinions or suggestions on the next research plan and feeds back to the applicant.

Article 62 For drug clinical trials included in the breakthrough therapeutic drug program, when the applicant finds that it no longer meets the inclusion conditions, it shall promptly propose to the Center for Drug Evaluation to terminate the breakthrough therapeutic drug program. If the Drug Evaluation Center finds that it no longer meets the inclusion conditions, it shall promptly terminate the breakthrough therapeutic drug program of this variety and inform the applicant.

Section II Conditional Approval Procedures

Article 63 During the clinical trial of drugs, drugs that meet the following conditions may apply for conditional approval:

(1) Drugs for the treatment of diseases that are seriously life-threatening and have no effective treatment, and clinical trials of drugs have data to confirm the efficacy and predict their clinical value;

(2) Drugs urgently needed in public health, and data from clinical trials of drugs have shown efficacy and can predict their clinical value;

(3) Vaccines urgently needed to deal with major public health emergencies or other vaccines identified by the National Health Commission as urgently needed, and the benefits are assessed to outweigh the risks.

Article 64 When applying for conditional approval, the applicant shall communicate with the Drug Evaluation Center on the conditions of conditional approval for marketing and the research work to be completed after marketing and submit an application for drug marketing authorization after communication and confirmation.

After review, if the requirements for conditional approval are met, the validity period of the conditional approval drug registration certificate, the research work that needs to be completed after marketing, and the time limit for completion and other related matters shall be specified in the drug registration certificate.

Article 65 During the review process, if it is found that the drug registration application included in the conditional approval procedure cannot meet the conditional approval conditions, the drug evaluation center shall terminate the conditional approval procedure for variety and inform the applicant to study and declare according to the normal procedures.

Article 66 For drugs with conditional approval, the holder shall take corresponding risk management measures after the drug is marketed, and complete drug clinical trials and other related research as required within the prescribed time limit and declare in the form of supplementary application.

If further research requirements are put forward when approving the vaccine registration application, the vaccine holder shall complete the research within the prescribed time limit.

Article 67 For drugs with conditional approval, if the holder fails to complete the research as required within the time limit or cannot prove that the benefits outweigh the risks, the State Medical Products Administration shall deal with them according to law until the drug registration certificate is cancelled.

Section III Priority Review and Approval Procedures

Article 68 When applying for drug marketing authorization, the following drugs with obvious clinical value may apply for priority review and approval procedures:

(1) clinically urgently needed shortage drugs, innovative drugs and improved new drugs for the prevention and treatment of major infectious diseases and rare diseases;

(2) New varieties, dosage forms and specifications of children’s drugs that meet the physiological characteristics of children;

(3) Vaccines and innovative vaccines urgently needed for disease prevention and control;

(4) Drugs included in the breakthrough therapeutic drug program;

(5) Drugs that meet the conditions of approval;

(6) Other priority review and approval circumstances stipulated by the State Medical Products Administration.

Article 69 Before submitting an application for drug marketing authorization, the applicant shall communicate with the Drug Evaluation Center. After communication and confirmation, at the same time as submitting the application for drug marketing authorization, the applicant shall submit an application for priority review and approval to the Drug Evaluation Center. If the conditions are met, the drug evaluation center will be included in the priority review and approval procedure after publicity in accordance with the procedures.

Article 70 The following policy support shall be given to drug marketing authorization applications included in the priority review and approval procedures:

(1) The review time limit for drug marketing authorization applications is 130 days;

(2) For clinically urgently needed rare disease drugs that have been marketed overseas but not marketed in China, the review time limit is 70 days;

(3) If it is necessary to verify, test and approve the generic name of the drug, priority shall be given;

(4) After communication and confirmation, supplementary technical data can be submitted.

Article 71 During the review process, if it is found that the drug registration application included in the priority review and approval procedure cannot meet the priority review and approval conditions, the Drug Evaluation Center shall terminate the priority review and approval procedure for the variety, review and inform the applicant in accordance with the normal review procedure.

Section IV Special Examination and Approval Procedures

Article 72 When there is a threat of public health emergencies and after the occurrence of public health emergencies, the State Medical Products Administration may decide in accordance with the law to implement special examination and approval of preventive and treatment drugs needed for emergency response to public health emergencies.

Article 73 For drug registration applications for special examination and approval, the National Medical Products Administration shall, in accordance with the principles of unified command, early intervention, rapid, efficient and scientific examination and approval, organize, accelerate and simultaneously carry out the acceptance, review, verification and inspection of drug registration. The circumstances, procedures, time limits and requirements for special examination and approval shall be carried out in accordance with the provisions of special examination and approval procedures.

Article 74 The use of drugs included in the special examination and approval procedures may be limited within a certain period of time and scope according to the specific needs of disease prevention and control.

Article 75 Where a drug incorporated in the special examination and approval procedures is found to no longer meet the requirements for inclusion, the special examination and approval procedures for the drug shall be terminated and the applicant shall be informed.

Chapter V Change and Re-registration of Drugs after Marketing

Section I Post-Market Studies and Changes

Article 76 The holder shall take the initiative to carry out post-market research of the drug, further confirm the safety, effectiveness and quality controllability of the drug, and strengthen the continuous management of the marketed drugs.

Where the drug registration certificate and its attachments require the holder to carry out relevant research work after the drug is marketed, the holder shall complete the work within the prescribed time limit and submit a supplementary application, record or report as required.

After the drug is approved for marketing, the holder shall continue to carry out research on the safety and effectiveness of the drug, timely file or submit a supplementary application for revising the instructions according to relevant data, and constantly update and improve the instructions and labels. According to its duties, the drug supervision and administration department may require the holder to revise the instructions and labels according to the results of adverse drug reaction monitoring and post-marketing evaluation of drugs.

Article 77 Changes after drug marketing shall be classified and managed according to their risks and impacts on drug safety, effectiveness and quality controllability, which shall be divided into examination and approval changes, filing changes and reporting changes.

The holder shall, in accordance with relevant regulations and with reference to relevant technical guidelines, comprehensively evaluate and verify the impact of changes on drug safety, effectiveness and quality controllability, and conduct corresponding research work.

The technical guidelines for post-marketing change research of drugs shall be formulated by the Center for Drug Evaluation and announced to the public.

Article 78 The holder shall declare the following changes in the form of supplementary application and implement them after approval:

(1) Major changes in the drug production process;

(2) Changes in the drug instructions involving effectiveness and other contents that increase safety risks;

(3) The holder transfers the drug marketing authorization;

(4) Other changes that require approval as stipulated by the State Medical Products Administration.

Article 79 For the following changes, the holder shall report to the drug regulatory authorities of the local province, autonomous region or municipality directly under the Central Government for the record before the changes are implemented:

(1) Moderate changes in the drug production process;

(2) Changes in the content of drug packaging labels;

(3) Sub-packaging of drugs;

(4) Other changes that need to be filed as stipulated by the State Medical Products Administration.

If the above-mentioned changes occur in overseas production drugs, they shall be reported to the Drug Evaluation Center for the record before the changes are implemented.

The procedures and requirements for the filing of drug sub-packaging shall be formulated and issued by the Center for Drug Evaluation.

Article 80 The holder shall report the following changes in the annual report:

(1) Minor changes in the drug production process;

(2) Other changes that need to be reported as stipulated by the State Medical Products Administration.

Article 81 If a supplementary application submitted after a drug is marketed requires verification and inspection, it shall be carried out with reference to the relevant drug registration verification and inspection procedures of these Measures.

Section II Drug Re-registration

Article 82 The holder shall apply for re-registration six months before the expiration of the validity period of the drug registration certificate. The application for re-registration of drugs produced in China shall be submitted by the holder to the drug supervision and administration department of the province, autonomous region or municipality directly under the Central Government where it is located, and the application for re-registration of drugs produced overseas shall be submitted by the holder to the drug evaluation center.

Article 83 After the application for drug re-registration is accepted, the drug regulatory authorities or drug evaluation centers of provinces, autonomous regions and municipalities directly under the Central Government shall conduct post-marketing evaluation and adverse reaction monitoring of the holders, and examine the relevant work required by the drug approval documents and drug regulatory authorities, as well as the changes in the information stated in the drug approval documents. If it meets the requirements, it shall be re-registered, and a drug re-registration approval notice shall be issued. If it does not meet the requirements, it will not be re-registered, and it will be reported to the State Medical Products Administration for cancellation of the drug registration certificate.

Article 84 Any of the following circumstances shall not be re-registered:

(1) Failing to apply for re-registration after the expiration of the validity period;

(2) Within the validity period of the drug registration certificate, the holder fails to perform the responsibility of continuously inspecting the quality, efficacy and adverse reactions of the drug;

(3) Failure to complete the drug approval documents and the research work required by the drug supervision and administration department within the prescribed time limit without reasonable reasons;

(4) After post-marketing evaluation, the curative effect is inaccurate, the adverse reaction is serious, or it endangers human health due to other reasons;

(5) Other circumstances where re-registration is not allowed as stipulated by laws and administrative regulations.

For drugs that cannot be re-registered, the drug registration certificate shall be cancelled when the validity period of the drug registration certificate expires.

Chapter VI Acceptance, Withdrawal of Application, Examination and Approval Decision and Dispute Resolution

Article 85 After receiving the drug registration application, the drug supervision and administration department shall conduct a formal examination, and make a decision on whether to accept it according to the following circumstances:

(1) If the application does not need to obtain an administrative license according to law, a decision of rejection shall be made immediately, and the reasons shall be explained.

(2) If the application matter does not fall within the scope of authority of the department according to law, it shall immediately make a decision of rejection and inform the applicant to apply to the relevant administrative organ.

(3) If there are errors in the application materials that can be corrected on the spot, the applicant shall be allowed to correct them on the spot; After the correction, if the application materials are complete and conform to the legal form, it shall be accepted.

(4) If the application materials are not complete or do not conform to the statutory form, the applicant shall be informed of all the contents to be corrected on the spot or within five days. If the application materials need to be returned together with the notification according to the regulations, they shall be returned. The applicant shall complete the supplement and correction of the materials within 30 days. If the applicant fails to correct the time limit without justifiable reasons, the application shall be deemed to have been abandoned, and no decision shall not be made. If the applicant fails to inform the applicant within the time limit, it shall be accepted as of the date of receipt of the application materials.

(5) If the application matters fall within the scope of the functions and powers of the department, and the application materials are complete and in line with the statutory form, or the applicant submits all the supplementary and corrected materials as required, the application for drug registration shall be accepted.

After the application for drug registration is accepted, if the applicant needs to pay the fees, the applicant shall pay the fees in accordance with the provisions. If the applicant fails to pay the fee within the prescribed time limit, the drug registration review and approval shall be terminated.

Article 86 After the application for drug registration is accepted, if there is a new discovery of drug safety, the applicant shall report in time and supplement the relevant materials.

Article 87 After the drug registration application is accepted, if the applicant needs to supplement new technical data on the basis of the original application materials, the Center for Drug Evaluation shall, in principle, put forward a supplementary data request, and after listing all problems, notify the applicant in writing to submit supplementary materials within eighty days. The applicant shall submit all supplementary information as required at one time, and the time for supplementary information shall not be included in the time limit for drug review. After receiving all supplementary information from the applicant, the Drug Evaluation Center will start the review, and the review time limit will be extended by one third; If the priority review and approval procedure is applicable, the review time limit will be extended by a quarter.

If the applicant does not need to supplement new technical data but only needs the applicant to explain the original application materials, the Center for Drug Evaluation notifies the applicant to submit the relevant explanation as required within five days.

If the Center for Drug Evaluation believes that there are substantive defects that cannot be corrected, it will no longer require the applicant to supplement information. The decision of disapproval is made based on the existing application materials.

Article 88 During the review period, no new technical data shall be supplemented for drug clinical trial applications and supplementary applications during drug clinical trials; If new research needs to be carried out, the applicant may re-apply after withdrawal.

Article 89 After the application for drug registration is accepted, the applicant may withdraw the application. If it agrees to withdraw the application, the drug evaluation center or the drug supervision and administration department of the province, autonomous region, or municipality directly under the Central Government shall terminate its registration procedure and inform the technical institutions such as drug registration verification and inspection. In the process of review, verification and inspection, if illegal acts such as concealing the true situation or providing false information are found, they shall be dealt with in accordance with the law, and the applicant shall not withdraw the drug registration application.

Article 90 During the drug registration period, if the evaluation conclusion is unpassed, the Drug Evaluation Center shall inform the applicant of the reasons for the failure, and the applicant may raise an objection to the Drug Evaluation Center within fifteen days. The Center for Drug Evaluation conducts a comprehensive evaluation based on the applicants’ objections and gives feedback to the applicant.

If the applicant still has objections to the comprehensive evaluation results, the Drug Evaluation Center shall, in accordance with regulations, organize an expert advisory committee to demonstrate within 50 days, and form a final evaluation conclusion based on the expert demonstration results.

The applicant’s objection and expert argumentation time are not included in the review time limit.

Article 91 During the period of drug registration, if the applicant considers that the staff member violates the provisions or commits irregularities in the acceptance, evaluation, verification, inspection, examination and approval of drug registration, he may make a complaint and report to the unit to which he belongs or the organ at a higher level.

Article 92 Where an application for drug registration meets the statutory requirements, it shall be approved.

An application for drug registration shall not be approved under any of the following circumstances:

(1) The research data of the drug clinical trial application is insufficient to support the development of the drug clinical trial or fail to guarantee the safety of the subjects;

(2) The application materials show that there are major defects in the safety, effectiveness and quality controllability of the application drug;

(3) The application materials fail to prove the safety, effectiveness and quality controllability of the drug, or the evaluation considers that the risk of the drug is greater than the benefit;

(4) the applicant fails to supplement the information within the prescribed time limit;

(5) The applicant refuses to accept or fails to accept the drug registration verification and inspection within the prescribed time limit without justifiable reasons;

(6) In the process of drug registration, the application materials is untrue, and the applicant cannot prove its authenticity;

(7) the on-site inspection of drug registration or the sample inspection results do not meet the provisions;

(8) other circumstances that should not be approved as stipulated by laws and regulations.

Article 93 After the examination and approval of the drug registration application is completed, if the applicant has any objection to the administrative licensing decision, he may file an administrative reconsideration or administrative lawsuit according to law.

Chapter VII Working Time Limits

Article 94 The time limit stipulated in these Measures is the longest time for the acceptance, review, verification, inspection, examination and approval of drug registration. The work time limit related to the priority review and approval procedure shall be implemented in accordance with the relevant provisions of priority review and approval.

Professional and technical institutions such as drug evaluation centers shall clarify their working procedures and time limits and announce them to the public.

Article 95 After receiving the drug registration application, the drug supervision and administration department shall conduct a formal examination, and shall make a decision on acceptance, correction or rejection within five days.

Article 96 The time limit for drug registration review shall be implemented in accordance with the following provisions:

(1) The time limit for the review and approval of drug clinical trial applications and supplementary applications during drug clinical trials is 60 days;

(2) The review time limit for drug marketing authorization applications is 200 days, of which the review time limit for priority review and approval procedures is 130 days, and the review time limit for priority review and approval procedures for clinically urgently needed overseas marketed rare disease drugs is 70 days;

(3) The review time limit for separate declaration of imitation of domestic marketed chemical raw materials is 200 days;

(4) The review time limit for supplementary applications for changes in the examination and approval category is 60 days, and for supplementary applications for merger declarations, the review time limit is 80 days, of which the review time limit for clinical trial research data review and drug registration verification and inspection is 200 days;

(5) The time limit for approval of generic names of drugs is 30 days;

(6) The time limit for reviewing the suitability of over-the-counter drugs is 30 days.

The time limit for related review is consistent with the time limit for related drug preparations.

Article 97 The time limit for drug registration verification shall be implemented in accordance with the following provisions:

(1) The drug evaluation center shall notify the drug verification center to start the verification within 40 days after the acceptance of the drug registration application, and notify the applicant at the same time;

(2) In principle, the drug verification center completes the on-site verification of drug registration and production 40 days before the expiration of the review time limit, and feeds back the verification status, verification results and other relevant materials to the drug evaluation center.

Article 98 The time limit for drug registration and inspection shall be implemented in accordance with the following provisions:

(1) The time limit for sample inspection is 60 days, and the time limit for sample inspection and standard review at the same time is 90 days;

(2) The time limit for supplementary information in the process of drug registration and inspection is 30 days;

(3) In principle, the drug inspection agency shall complete the work related to drug registration inspection 40 days before the expiration of the review time limit, and feedback the drug standard review opinions and inspection reports to the drug evaluation center.

Article 99 The time limit for drug re-registration examination and approval is 120 days.

Article 100 Administrative examination and approval decisions shall be made within twenty days.

Article 101 The drug supervision and administration department shall issue and deliver the relevant administrative license within ten days from the date of making the drug registration approval decision.

Article 102 If it is really necessary to extend the time limit due to special circumstances such as variety characteristics and review, verification, inspection, etc., the extended time limit shall not exceed half of the original time limit. After approval by the person in charge of relevant technical institutions such as drug review, verification, inspection, etc., the technical institution that extends the time limit shall inform the applicant in writing and notify other relevant technical institutions.

Article 103 The following time shall not be included in the relevant working time limit:

(1) The time taken by the applicant to supplement information, rectify after verification, and check the production process, quality standards and instructions as required;

(2) the time of delaying verification, inspection, expert consultation meeting, etc. due to the applicants reasons;

(3) If the review and approval procedure is suspended according to the provisions of laws and regulations, the time occupied during the suspension of the review and approval procedure;

(4) When overseas verification is started, the time occupied by overseas verification.

Chapter VIII Supervision and Management

Article 104 The National Medical Products Administration is responsible for the supervision, management, assessment, evaluation, and guidance of relevant professional and technical institutions such as the Drug Evaluation Center and the drug supervision and administration departments of provinces, autonomous regions and municipalities directly under the Central Government to undertake the work related to drug registration management.

Article 105 The drug supervision and administration department shall supervise and inspect drug research and development activities in accordance with the provisions of laws and regulations. When necessary, it may conduct extended inspections on units and individuals that provide products or services for drug research and development. The relevant units and individuals shall cooperate and shall not refuse or conceal.

Article 106 The information center is responsible for establishing drug variety files, implementing coding management of drugs, and collecting drug registration declarations, safety-related reports during clinical trials, review, verification, inspection, approval, and approval of changes in drugs after marketing, filing, reports and other information, and continuously updating them. The relevant system for drug variety archives and coding management shall be formulated and published by the information center.

Article 107 The drug supervision and administration departments of provinces, autonomous regions and municipalities directly under the Central Government shall organize daily supervision and inspection of drug non-clinical safety evaluation research institutions and drug clinical trial institutions within their jurisdiction to comply with drug non-clinical research quality management standards and drug clinical trial quality management standards, and supervise their continuous compliance with statutory requirements. The National Medical Products Administration shall supervise and inspect research institutions such as drug non-clinical safety evaluation research institutions and drug clinical trial institutions as needed.

Article 108 The National Medical Products Administration shall establish a drug safety credit management system, and the Drug Verification Center shall be responsible for establishing drug safety credit files of drug non-clinical safety evaluation research institutions and drug clinical trial institutions, recording the issuance of licenses, 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. The drug supervision and administration department shall increase the frequency of supervision and inspection for those with bad credit records and may implement joint punishment in accordance with state regulations. The relevant system of drug safety credit files of drug non-clinical safety evaluation research institutions and drug clinical trial institutions shall be formulated and published by the Drug Verification Center.

Article 109 The State Medical Products Administration shall publish to the public the list of drug registration examination and approval items, legal basis, examination and approval requirements and processing time limit in accordance with the law, disclose the progress of drug registration to the applicant, and disclose the review conclusions and basis of approved marketed drugs to the public, as well as violations of laws and regulations found by supervision and inspection, and accept social supervision.

The instructions for approved drugs for marketing shall be made public to the public and updated in a timely manner. Among them, the vaccine should also disclose the label content and update it in time.

Without the consent of the applicant, the drug supervision and administration department, professional and technical institutions and their staff, and personnel involved in expert review shall not disclose the commercial secrets, undisclosed information or confidential business information submitted by the applicant, unless otherwise stipulated by the law or involving national security, Except for major social and public interests.

Article 110 Under any of the following circumstances, the State Medical Products Administration shall cancel the drug registration certificate and publish it:

(1) The holder proposes to cancel the drug registration certificate on his own;

(2) in accordance with the provisions of these Measures is not allowed to re-register;

(3) The holders’ drug registration certificate, drug production license and other administrative licenses have been revoked or revoked according to law;

(4) In accordance with the provisions of Article 83 of the Drug Administration Law, the curative effect is inaccurate, the adverse reaction is serious, or human health is endangered for other reasons;

(5) In accordance with the provisions of Article 61 of the Vaccine Administration Law, after post-marketing evaluation, the abnormal reaction to vaccination is serious or other reasons endanger human health;

(6) In accordance with the provisions of Article 62 of the Vaccine Administration Law, after post-marketing evaluation, it is found that the product design, production process, safety, effectiveness or quality controllability of the vaccine variety are obviously inferior to other vaccine varieties for prevention and control of the same disease;

(7) in violation of laws and administrative regulations, failing to complete the corresponding research work within the prescribed time limit in accordance with the requirements of drug approval documents or the requirements of drug regulatory authorities without reasonable reasons;

(8) other circumstances in which the drug registration certificate should be cancelled according to law.

Chapter IX Legal Liability

Article 111 In the process of drug registration, those who provide false certificates, data, materials, samples or take other means to defraud clinical trial licenses or drug registration licenses shall be subject to Article 123 of the Drug Administration Law.

Article 112 Whoever applies for clinical trials of vaccines, registering with false data, materials, samples, or committing other acts of deception shall be dealt with in accordance with Article 81 of the Vaccine Administration Law.

Article 113 In the course of drug registration, drug non-clinical safety evaluation research institutions, drug clinical trial institutions, etc., fail to comply with the quality control standards for non-clinical research and drug clinical trials, etc., shall be dealt with in accordance with Article 126 of the Drug Administration Law.

Article 114 A drug clinical trial without approval shall be dealt with in accordance with Article 125 of the Drug Administration Law; without archival bioequivalence test, it shall be dealt with in accordance with Article 127 of the Drug Administration Law.

Article 115 During the period of a drug clinical trial, if safety problems or other risks are found, the clinical trial sponsor fails to timely adjust the clinical trial plan, suspend or terminate the clinical trial, or fails to report to the State Drug Administration, it shall be dealt with in accordance with Article 127 of the Drug Administration Law.

Article 116 The applicant, violates the provisions of Articles 28 and 33 of these Measures, shall be ordered to make corrections under any of the following circumstances: those who fails to make corrections within the time limit shall be imposed a fine of not less than 10,000 yuan but not more than 30,000 yuan:

(1) Failure to register on the drug clinical trial registration and information disclosure platform as required before carrying out drug clinical trials;

(2) Failure to submit the safety update report during research and development as required;

(3) Failure to register clinical trial results and other information after the completion of drug clinical trials.

Article 117 If a drug inspection agency issues a false inspection report when undertaking the inspection work required for drug registration, it shall be dealt with in accordance with Article 138 of the Drug Administration Law.

Article 118 If a drug registration certificate is issued to a drug that does not meet the conditions and is approved for clinical trials of drugs or does not meet the conditions, it shall be dealt with in accordance with Article 147 of the Drug Administration Law.

Article 119 If the drug supervision and administration department and its staff commit violations of laws and regulations in the process of drug registration and management, they shall be dealt with in accordance with relevant laws and regulations.

Chapter X Supplementary Provisions

Article 120 Applications for registration of narcotic drugs, psychotropic drugs, toxic drugs for medical use, radioactive drugs, pharmaceutical precursor chemicals and other drugs with other special management regulations shall be handled in accordance with the provisions of these Measures and shall also comply with other relevant provisions of the state.

Article 121 The standards for exporting vaccines shall comply with the standards or contract requirements of the importing country (region).

Article 122 If the drug-device combination products to be declared for registration have similar products defined as drugs by attributes, they shall be declared according to drugs; If the attributes have not yet been defined, the applicant shall apply to the National Medical Products Administration for the definition of the product attributes before applying for registration. If the attribute is defined as drug-based, registration shall be carried out in accordance with the procedures stipulated in these Measures, and the research data belonging to the medical device part shall be transferred to the Drug Evaluation Center for comprehensive review after the Medical Device Technology Evaluation Center of National Medical Products Administration has made the review conclusion.

Article 123 The format of the approval number for domestic production of drugs is: National Drug Approval Character H (Z, S) + four-digit year number + four-digit serial number. The format of the approval number of drugs produced in Hong Kong, Macau and Taiwan is: National Drug Approval Character H (Z, S) C + four-digit year number + four-digit serial number.

The format of the approval number for overseas production drugs is: National Drug Approval Character H (Z, S) J + four-digit year number + four-digit serial number.

Among them, H represents chemical drugs, Z represents traditional Chinese medicine, and S represents biological products.

The drug approval number will not be changed due to the change of registration items after marketing.

If there are other provisions on traditional Chinese medicine, such provisions shall prevail.

Article 124 The electronic document of drug registration approval certificate and the electronic document of API approval document produced by the drug supervision and administration department have the same legal effect as the paper document.

Article 125 The time limit stipulated in these Measures shall be calculated on the basis of working days.

Article 126 These Measures shall come into force on July 1, 2020. On July 10, 2007, the “Administrative Measures for Drug Registration” promulgated by Order No. 28 of the former State Food and Drug Administration shall be abolished at the same time.