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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
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
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
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
INDUSTRY
INDUSTRY
Top 10 CROs Using China's Human Genetic Resources in International Clinical Trials
From Jan. to Oct. 2022, among the 3,632 international clinical trials approved by China to use the its human genetic resources outside China, about 52% are conducted by contract research organizations (CROs) and about 48% by the applicants themselves.
Nov 23, 2022
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