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INSIGHTS

We manage the entire NMPA process, from preliminary assessments and documentation to application submission and post-registration support.

Service

Drug Registration Services in China

We streamline your drug registration process through NMPA approval, from preliminary assessments and documentation to application submission and post-registration support.

Regulatory Analysis, Industry Insight

Navigating the Maze

Dive deep into China's OTC drug registration process, exploring overseas clinical trial acceptance, first-in-market opportunities, and local testing requirements. Gain crucial insights for successful market entry and regulatory compliance in this comprehensive guide.

Industry Insight

From Control to Innovation

The Transformation of China's Drug Administration Law. China’s pharmaceutical regulatory landscape is undergoing a dramatic shift, with far-reaching implications for both domestic and international players.

Regulatory Analysis

Compliance Guidelines for Disinfection Product Manufacturers in China

A comprehensive guide for foreign manufacturers entering China's disinfection product market, ensuring compliance from pre-market requirements to post-market responsibilities.

Regulatory Analysis, Industry Insight

Navigating China’s Evolving Drug Registration Landscape: A Comprehensive Guide for Regulatory Professionals

Dive deep into China’s drug registration process, exploring overseas clinical trial acceptance, first-in-market opportunities, and local testing requirements.

Regulatory Text

Administrative Measures for Drug Registration

Outline comprehensive regulations for drug research, registration, and market authorization, ensuring safety, efficacy, and quality control across TCM, chemical drugs, and biological products.

Case Stories

Pioneering Sustainable Packaging Solutions

This is the story of how CRC Team went beyond traditional sourcing to help a renowned Australian skincare group successfully navigate the complex landscape of sustainable packaging in China, paving the way for their ethical and eco-friendly market entry.

Regulatory Text

Specification for Hygienic Supervision of Disinfection Products

Outline comprehensive regulations for disinfectant manufacturers, importers, and users, emphasizing strict hygiene supervision to safeguard public health in the medical sector.

Case Stories

Pioneering Men’s Cruelty-Free Skincare in China with Bulldog

Launching a new brand is always a challenge. Now, imagine doing it in one of the world’s most complex regulatory environments while staying true to your ethical principles. This is the story of how CRC Team went beyond compliance to help Bulldog Skincare.

Regulatory Text

Administrative Measures on Disinfection

Outline comprehensive regulations for disinfection management, product standards, and service providers, aiming to prevent infectious diseases and protect public health.

Regulatory Text

Notice of the National Health and Family Planning Commission on Regulations on Hygiene and Safety Evaluation of Disinfection Products

A comprehensive framework for evaluating, classifying, and managing disinfection products.

Regulatory Text

Management Practice for Labeling and Instructions of Disinfection Products

Provide comprehensive guidelines for labelling of disinfectants, ensuring product safety and efficacy through stringent regulatory oversight and standardized information disclosure

Regulatory Text

Drug Administration Law of the People’s Republic of China

Provide a comprehensive framework for drug development, production, and distribution, emphasizing safety, efficacy, and accessibility while promoting innovation in both modern and TCM sectors.

Case Stories

Pioneering Cruelty-Free Beauty in China with Subtle Energies

In 2018, Subtle Energies, an Australian natural skincare brand founded in 1993, faced a formidable challenge: entering the Chinese market without compromising their unwavering commitment to cruelty-free practices.

Regulatory Text

Regulations on the Administration of Drug Instructions and Labels

Provide regulatory standards for drug information disclosure, ensuring clear, accurate, and scientifically-backed instructions and labeling.

Since 2012, Knudsen & CRC has been at the forefront of supporting international brands in overcoming regulatory barriers in highly regulated markets. Our expertise spans across Cosmetics, Skincare, Food & Beverages, Nutritional Supplements, Functional Health Foods, and more. At Knudsen & CRC, we go beyond traditional compliance, we’re shaping a world where international brands thrive in highly regulated markets. Our diverse team of global experts doesn’t just navigate complex regulations—we transform them into opportunities for growth.
We are pioneering change, fostering collaboration, and delivering transparency. Together, we’re not just meeting standards; we’re setting them.

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