On January 27, 2026, China’s State Council issued revised Implementing Regulations of the Drug Administration Law of the People’s Republic of China, which will go into effect on May 15, 2026. The regulations refine key provisions of the Drug Administration Law, which has been in effect since December 2019, and provide clarification on pharmaceutical regulations in China.
The update strengthens incentives for innovation and introduces more straightforward pathways for faster market entry. Some of the key highlights are outlined below:
- Accelerated approval pathways for drugs of significant clinical benefit, including breakthrough therapy designation, conditional approval, and priority review.
- Pediatric medicines may receive up to two years of market exclusivity for eligible new products, formulations, or expanded indications.
- Orphan drugs may qualify for up to seven years of market exclusivity as long as the Marketing Authorization Holder (MAH) can ensure a stable supply.
- Drug trial data protection of up to six years for drug products containing novel chemical entities, covering independently generated, undisclosed trial data. During this protection period, applications that depend on protected data will not be approved without consent from the protected product’s MAH.
Written by: Ames Gross – President and Founder, Pacific Bridge Medical (PBM)
Mr. Gross founded PBM in 1988 and has helped hundreds of medical companies with regulatory and business development issues in Asia. He is recognized nationally and internationally as a leader in the Asian medical markets. Mr. Gross has a BA degree, Phi Beta Kappa, from the University of Pennsylvania and an MBA from Columbia University.