China Encourages Innovative Drug R&D in Draft of Regulations for Implementing DAL, 2022
On May 9, China National Medical Products Administration (NMPA) released the draft of the revised Regulations for Implementation of the Drug Administration Law (hereafter referred to as the Regulations) for public comment.
The Regulations were first issued with immediate effect in 2002 and were later revised in 2016. Compared to the 2016 revised version, the draft of the 2022 version includes 101 more articles to conform to the pharmaceutical policy reforms in the recent years and the Drug Administration Law revised in 2019. The new contents involve a marketing authorization holder system, patent protection, and pharmacovigilance, whose regulations just came out in the past few years. (Pharmaceutical Application Services)
RELATED: China’s Marketing Authorization Holder (MAH) System; China’s Drug Patent Linkage System; China’s Good Pharmacovigilance Practices.
Regulation Contents
| Contents of the Regulations for Implementation of the Drug Administration Law | |
| 2016 Revised Version1 | Revised Draft of the 2022 Version for Consultation2 |
| Chapter I: General Provisions
Chapter II: Administration of Drug Manufacturers Chapter III: Administration of Drug Distributors Chapter IV: Administration of Pharmaceuticals in Medical Institutions Chapter V: Administration of Drugs Chapter VI: Administration of Drug Packaging Chapter VII: Administration of Drug Pricing and Advertisement Chapter VIII: Supervision of Drugs Chapter IX: Legal Liability Chapter X: Supplementary Provisions |
Chapter I: General Provisions
Chapter II: Drug Research and Registration – Section 1: Basic Requirements – Section 2: Drug Research and Development – Section 3: Drug Marketing Authorization – Section 4: Traditional Chinese Medicine Registration Administration – Section 5: Drug Intellectual Property Protection Chapter III: Drug Marketing Authorization Holder Chapter IV: Drug Manufacturing Chapter V: Drug Distribution Chapter VI: Pharmaceutical Administration in Medical Institutions Chapter VII: Drug Supply Support Chapter VIII: Supervision and Administration Chapter IX: Legal Liability Chapter X: Supplementary Provisions |
Regulation Highlights
The Regulations embody China’s incentive policy trends, e.g., expediting drug review and approval, encouraging the development of pediatric and rare disease drugs, etc. Here are several highlights.
Pharmaceutical Innovation
China supports pharmaceutical innovation in various aspects:
- fundamental research, applied research, and original innovation of drugs;
- pharmaceutical innovation oriented by clinical value;
- supporting enterprises in using advanced technical equipment to improve drug safety;
- scientific projects, financing, credit loans, procurement, pricing, and medical insurance;
- supporting enterprises in setting up independent and joint R&D institutions
- cooperation between enterprises, colleges, research institutions, and medical institutions for drug research and innovation;
- drug’s intellectual property protection;
- improving the capability of independent innovation in the pharmaceutical field.
Contact Us
BaiPharm, a subsidiary of REACH24H Consulting Group, is specialized in pharmaceutical industry consultancy services. With our experts across China, Japan, South Korea, the United States, and Europe, BaiPharm is fully qualified to engage in complex market entry projects of finished drugs, APIs, excipients, and packaging materials for most key markets.
If you have any questions about the market approval of generic drugs, please feel free to contact us.
Tel: +86 (0)571-87007555
Email: customer@reach24h.com
