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Comprehensive coverage on the latest pharmaceutical regulatory update and industry activities in China.
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REGULATION
Law & Regulation
Reference Listed Drug (RLD)
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How Will China Regulate and Boost Pharmaceutical Industry by 2025
At the end of 2021, China announced its National Plan for Promoting Drug Safety and the High-quality Development of the Pharmaceutical Industry during the 14th Five-Year Plan (2021-2025). To realize the 2035 vision which includes an internationally-advanced drug regulatory system, China sets tasks to be completed by 2025.
Jan 14, 2022
REGULATION
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
REGULATION
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
REGULATION
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