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Comprehensive coverage on the latest pharmaceutical regulatory update and industry activities in China.
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REGULATION
Outsourcing Manufacture: Regulatory Considerations for Drug Marketing Authorization Holders (MAHs)
The drug marketing authorization holder (MAH) system has been effective in China since the revised Drug Administration Law went into force in 2019. The system entitles MAHs to entrust other companies with the manufacturing activities. Thus, quite a few MAHs outsource manufacture to other companies, and save more resources for R&D or other areas.
Aug 17, 2023
REGULATION
Law & Regulation
Pharmacopoeia
Reference Listed Drug (RLD)
MAH
Bioequivalence (BE)
Post-market
Generic Drug
OTC Drug
Drug Registration
Monthly Recap: China Pharmaceutical Regulatory Updates | May 2023
China drug regulatory updates in May 2023: 1. China to Tighten Regulation on Drug MAHs That Outsource Manufacture; 2. China May Disallow ANDAs of Generic Drugs with No RLDs and Low Clinical Value; 3. China Outlines Path for Adding Pediatric Medication Information to Authorized Drugs; 4. China Greenlights One Rx-to-OTC Switch; 5. China Releases Two RLD Lists...
Jun 15, 2023
REGULATION
Change Control for Transport of Medicinal Products
Any change from design or predefined processes requires risk assessment and potential impact evaluation for both the transport process and, consequently, the product. This article discusses the importance of having a structured, compliant Change Control (CC) process in place for medicinal product manufacturers as well as for their qualified logistics vendors.
Dec 20, 2022
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
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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