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Comprehensive coverage on the latest pharmaceutical regulatory update and industry activities in China.
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REGULATION
China Issues Draft Regulation on MAH as Main Responsibility Entity for Drug Quality
Drug marketing authorization holders (MAH) in China are required to establish drug quality management system and be responsible for the safety, effectiveness, and quality controllability during drug development, manufacture, supply, and use according to the Drug Administration Law, Good Manufacturing Practices (GMP), Good Supply Practices (GSP), Good Pharmacovigilance Practices (GVP), and relevant regulations.
Dec 16, 2022
REGULATION
China Requires Online Drug Sellers and E-commerce Platforms to File Necessary Information
On Nov. 31, 2022, China National Medical Products Administration specified the requirements for online drug sellers and online drug transaction platforms to file necessary information to local regulators.
Dec 14, 2022
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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
REGULATION
China Bans a List of Drugs from Online Sales: Vaccines, Anesthetics, and More
The list of drugs banned online in China include vaccines, blood products, anesthetics, psychiatric drugs, toxic drugs for medical use, radioactive drugs, medical precursor chemicals, etc. The list takes effect on Dec. 1, 2022, the same day when the Administrative Measures for Supervising Online Sales of Drugs came into force.
Dec 08, 2022
REGULATION
No More Papers—China to Require Compact Disc Submission for All Drug Registration Applications
On Nov. 4, China National Medical Products Administration released a series of draft regulations on electronic drug registration application, requiring application dossiers to be submitted in compact discs instead of paper.
Nov 10, 2022
REGULATION
Monthly Recap: China Pharmaceutical Regulatory Updates | October 2022
Find out the China's pharmaceutical regulatory updates in October: 1. China NMPA Issues New Administrative Measures for Drug Recall;
2. China NMPA Temporarily Extends Deadlines for Submitting Supplemental Documents;
3. China NMPA Consults on GLP Certification Regulation;
4. China NMPA Releases the 61th List of RLDs;
5. China NMPA to Issue Electronic Certificates and Approval Documents;
6. CDE Issues a Series of Guidelines and Rules;
7. ChP Commission Seeks Public Advice on Drug Standards.
Nov 02, 2022
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