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Comprehensive coverage on the latest pharmaceutical regulatory update and industry activities in China.
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REGULATION
China Requires Electronic Submission of All Drug Registration Application Documents from Jan. 1, 2023
China NMPA requires that all documents for drug registration applications, as well as supplemental documents sent during the review, shall be submitted electronically in compact disks with no paper required, from Jan. 1, 2023.
Jan 01, 2023
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
Law & Regulation
Guideline
Pharmacopoeia
MAH
CMC
Clinical Trial
Bioequivalence (BE)
Innovative Drug
API
Drug Registration
E-commerce
Packaging
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
INDUSTRY
Marketing Approval
Innovative Drug
Generic Drug
Biological Product
Cancer
Cardiovascular Disease
Vaccine
Drug Registration
New Drug
Monthly Report: New Drug Approvals in China | November 2022
In October 2022, China NMPA approved 14 new drugs, including 12 chemical drugs and 2 biological products.
Dec 05, 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
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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