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Comprehensive coverage on the latest pharmaceutical regulatory update and industry activities in China.
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REGULATION
China Tightens Regulation on Outsourced Manufacturing for Drug Marketing Authorization Holders (MAHs)
On Oct. 23, 2023, China's NMPA issued the Notice on Enhancing the Supervision and Management of Outsourced Manufacturing for Drug Marketing Authorization Holders (MAHs), which took immediate effect.
Oct 26, 2023
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
China to Tighten Regulation on Drug Marketing Authorization Holders (MAHs) That Outsource Manufacture
On May 24, China NMPA issued the draft Notice of Enhancing the Supervision of Drug Marketing Authorization Holders (MAHs) That Outsource Manufacture. The Notice came with an appendix: Guidance for On-site Inspection of Drug MAHs That Outsource Manufacture. The draft is open to public advice until June 23 this year.
Jun 02, 2023
REGULATION
Pharmacopoeia
MAH
Marketing Approval
CMC
Clinical Trial
Bioequivalence (BE)
NRDL
Drug Registration
New Drug
Real World Data
Packaging
Monthly Recap: China Pharmaceutical Regulatory Updates | February 2023
China's regulatory updates in Feb. 2023: 1. China NMPA Issues TCM Registration Rules; 2. China CDE Rolls Out Pharmaceutical Guidelines; 3. Chinese Pharmacopoeia Commission Issues Draft Standards
Mar 07, 2023
REGULATION
Monthly Recap: China Pharmaceutical Regulatory Updates | December 2022
Check out China's pharmaceutical regulatory updates in December 2022: 1. China NMPA Adds OTC Status to a Former Prescription Drug; 2. China NMPA Releases the 62nd List of RLDs; 3. China NMPA Issues Regulation on Supervising MAH as the Main Responsible Entity for Drug Safety; 4. China NMPA Requires Licenses for Importing and Exporting Anesthetics and Psychoactive Drugs; 5. China CDE Specifies Requirements for Electronic Submission of Drug Applications...
Jan 09, 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