Peiling Shih, Executive Director, Regulatory Strategic Development, APAC
Sarah Qu, Associate Director, Regulatory Strategic Development, China

The National People’s Congress of China recently accepted a major revision to the drug administration law, which will take effect Dec. 1. This overhauls the law, which last had a major change in 2001.

The revised law stipulates the strictest standards ever to regulate the Chinese pharmaceutical supply chain in an effort to combat serious issues in counterfeit drugs as well as poor quality and high prices. Complete supervision of everything from research and development to the manufacture, distribution, sales, and marketing of drugs will be covered by the revised law. Infrastructure for tracking drug distribution and post-marketing pharmacovigilance will be built and risk-based management will be implemented.

Another major change attracting attention is the formal introduction of a drug approval system by a marketing authorization holder (MAH). By current regulations, the manufacturer of a drug holds the drug license in China. This new MAH system will allow startup biotechnology companies and research institutions to use contract manufacturing, as employed in developed markets, to stimulate innovative drug development. The MAH system was successfully tested in a pilot program in 10 regions beginning in 2016. Once the drug administration law goes into effect, this MAH system will be extended nationwide.

The National Medical Products Administration will review MAH qualifications during the technical review for the registration application. To serve as an MAH, an applicant will be evaluated on its capabilities in quality management, risk control and mitigation, and compensation.

The law established a legal basis for many systems created in the last few years of the reform such as the 60-day IND silent approval, CDE consultation, the acceptance of foreign data to fulfill unmet medical needs, priority review and conditional approval, the DMF system for raw materials, excipients and packaging materials, and the accreditation for clinical trial institutions from certification to notification.

If you would like to learn more about the new revision, please contact Clinipace. Our regulatory strategy development team will be more than happy to assist you.

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