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Comprehensive coverage on the latest pharmaceutical regulatory update and industry activities in China.
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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
REGULATION
Drug Recall in China: MAHs Shall Shoulder the Main Responsibility
China NMPA's new Administrative Measures for Drug Recall will take effect on Nov. 1, 2022. Different from the previous 2007 version, the new Measures designates drug marketing authorization holders (MAHs), instead of manufacturers, as the main responsible entity for drug recall.
Oct 31, 2022
REGULATION
Understanding China's Good Laboratory Practice (GLP) Certification Regulation Draft
On Oct. 21, 2022, China NMPA issued the draft of Administrative Measures for Good Laboratory Practice (GLP) Certification for public comments. GLP certification means NMPA inspects and evaluates if research institutes comply with GLP during non-clinical safety evaluation for pharmaceuticals.
Oct 25, 2022
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