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Comprehensive coverage on the latest pharmaceutical regulatory update and industry activities in China.
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REGULATION
China Consults on Self-Evaluation Report Guidance for Generic Drug Registration
On April 2, 2024, China’s Center for Drug Evaluation (CDE) released the two drafts of Chemical, Manufacturing, and Controls (CMC) Self-evaluation Reports on Class 3 Chemical Drug Registration Applications, one for drug substances, and the other for drug products.
Apr 15, 2024
REGULATION
China CDE Updates eCTD Structure for Drug Registration Applications
On Dec 11, 2023, China CDE announced updates regarding the electronic submission of drug registration applications. These updates are compiled into the Technical Requirements for Compact Disks Containing Application Dossiers and Electronic Common Technical Document (eCTD) Structure. In addition, CDE has also introduced the eCTD Validation Criteria as a regulatory document. These three documents will come into effect on March 1, 2024.
Dec 18, 2023
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Excipient
Monthly Recap: China Pharmaceutical Regulatory Updates | November 2022
Check out China's Pharma Regulatory Updates for November 2022: 1. China NMPA Renews Classifications of Sodium Hyaluronate Products;
2. China NMPA Requires All Drug Registration Application Documents to Be Submitted in Compact Disks; 3. China NMPA Consults on Chemical API Registration Renewal Regulation, and more.
Dec 09, 2022
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The 15th Rare Disease Day: China's Policy & Market Overview
China tries to make rare disease drugs available to more patients via measures like expediting the marketing approval of the drugs and reimbursing part of the medical expenses. Meanwhile, the rare disease treatment market is expanding rapidly.
Mar 04, 2022
REGULATION
China Cracks Down on Monopolies in Active Pharmaceutical Ingredient Industry
On Nov. 18, China issued the Anti-Monopoly Guidance for Active Pharmaceutical Ingredients, clarifying regulations against monopoly agreements, abuse of market power, and concentration of undertakings in the API industry.
Nov 26, 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
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