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 | March 2021 In Mar. 2021, the Center for Drug Evaluation released a total of seven announcements including contents such as technical requirements for drug research & evaluation. ChemLinked BaiPharm team collected the documents and summarized their keynotes.
Apr 08, 2021
China Releases Second Batch of 17 Encouraged Generic Drugs China officially issued the Second Batch of 17 Encouraged Generic Drugs, which could benefit from preferential policy support in terms of priority review and approval, clinical trials and critical generic technology researches in China.
Mar 26, 2021
China Announces Technical Requirements for Overseas Approved Chemical Drugs Seeking Domestic Marketing Authorization On Mar. 8, China Center of Drug Evaluation issued the Technical Requirements for CMC Studies and Evaluation of Overseas-approved Chemical Drugs without Domestic Marketing Authorization (Trial).
Mar 09, 2021
China Releases Draft List of Second Batch of Encouraged Generic Medicines On Dec. 30, 2020, China National Health Commission issued the Draft List of Second Batch of 19 Generic Medicines, encouraging pharmaceutical firms to develop and produce them. Medicines for chronic obstructive pulmonary disease and asthma are included in the list.
Dec 31, 2020
- 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