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Comprehensive coverage on the latest pharmaceutical regulatory update and industry activities in China.
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REGULATION
China GLP Certification Regulation Takes Effect on July 1, 2023
China's Administrative Measures for Drug Good Laboratory Practice (GLP) Certification takes effect on July 1, 2023. The regulation says GLP certification is mandatory for institutes that conduct non-clinical safety evaluation studies for drug registration applications in China.
Jul 01, 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
Law & Regulation
Guideline
Reference Listed Drug (RLD)
Marketing Approval
CMC
Clinical Trial
Bioequivalence (BE)
Generic Drug
Drug Registration
China May Disallow Applications of Generic Drugs with No RLDs and Low Clinical Value
On May 24, China CDE released the draft Notice of Generic Drug Study Without Reference Listed Drugs (RLDs). The draft states the precondition for developing copycats of drugs which are not listed in China’s RLD Catalog—the drugs have to be widely used, with no alternatives, and with benefits trumping risks.
Jun 05, 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
Law & Regulation
Guideline
Pharmacopoeia
CMC
Clinical Trial
Volume-based Procurement
Cancer
Drug Registration
Monthly Recap: China Pharmaceutical Regulatory Updates | April 2023
Regulatory updates in Apr. 2023: 1. China Grants Four Rx-to-OTC Switches; China Adjusts Catalogs of Anesthetics and Psychoactive Drugs; China Reveals the 8th Medical VBP’s Bidding Result...
May 15, 2023
REGULATION
[Updated] China Issues the 2020 Edition of Chinese Pharmacopoeia
On Jul. 2, 2020, the National Medical Product Administration and the National Health Commission published the 2020 Edition of the Pharmacopoeia of the People’s Republic of China, which will come into force on Dec. 30, 2020.
Apr 18, 2023
REGULATION
Monthly Recap: China Pharmaceutical Regulatory Updates | March 2023
China regulatory updates in Mar. 2023: 1. China NMPA Grants OTC Status to Two Former Prescription Drugs; 2. China NMPA Releases Two RLD Lists; 3. China NMPA Releases RLD Adjustment Procedures; 4. China CDE Trials Work Procedures for Expediting the Review of Innovative Drug’s Marketing Authorization Application; 5. China CDE Consults on Dossier Requirements for Moving the Manufacturing Site to China...
Apr 13, 2023
REGULATION
China May Delist Ineligible Reference Listed Drugs (RLDs) of Chemical Generic Drugs
On Mar. 24, 2023, China NMPA released the Procedures for Adjusting Reference Listed Drugs (RLDs) of Chemical Generic Drugs (Trial) with immediate effect. RLDs are reference drugs to which generic drugs should be equivalent in safety and efficacy. NMPA finds that some listed RLDs no longer meet the Chinese Pharmacopoeia standards or the current technological requirements. That’s why NMPA formulates and implements the RLD Adjustment Procedures.
Mar 28, 2023
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