Comprehensive coverage on the latest pharmaceutical regulatory update and industry activities in China.
Marketing Approval Priority Review and Approval Innovative Drugs Generic Drugs Drug Registration New DrugsMonthly Report: New Drug Approvals in China | Aug. 2021 In Aug. 2021, China NMPA nodded for nine new drug products including Tislelizumab Injection, Apremilast Tablet and Nivolumab Injection.
Sep 14, 2021
China Rolls Out Measures to Establish Drug Patent Linkage System China tries to balance the patent protection of innovative drugs and the development of generics. MAHs of innovative drugs can bring a lawsuit or apply for an administrative ruling to protect patents. The first generics that successfully challenge the registered innovative drugs can enjoy 12-month marketing exclusivity.
Jul 23, 2021
Clinical Real-World Data Pilot Program: Fast-Track Entry Pathway into China It usually takes at least three to five years for innovative new medical products to enter the Chinese market. However, procedure could be much shorter with the application supported by clinical RWD.
Apr 12, 2021
- Monthly Recap: China Pharmaceutical Regulatory Updates | July 2021
- Expedited Programs for Drug Registration in China
- China Rolls Out Measures to Establish Drug Patent Linkage System
- China Drug Evaluation Report 2020-Reform of Drug Review & Approval System
- Monthly Report: New Drug Approvals in China | July 2021