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
Monthly Recap: China Pharmaceutical Regulatory Updates | June 2021 The monthly recap is intended to bring you the dynamics of recent major laws and regulations issued by China drug regulators, including National Medical Products Administration (NMPA) and the Center for Drug Evaluation (CDE).
Jul 20, 2021
China Approves First Domestic CAR-T Therapy Fosun Kite's Axicabtagene Ciloleucel recently received marketing authorization by NMPA, becoming the first CAR-T therapy approved in China. The Chinese CAR-T industry is thus eyeing a promising future, but the road to market success is challenging.
Jul 12, 2021
A Record Number of Foreign Companies Wins the Bidding for China's Latest Drug Procurement 251 products from 148 companies won the bidding on June 23 in Shanghai for the latest and fifth round of China’s national centralized drug procurement. The bidding saw some record numbers. One of them is the unprecedented number of 10 international pharma companies successfully earning places in the procurement program.
Jun 30, 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