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Comprehensive coverage on the latest pharmaceutical regulatory update and industry activities in China.
REGULATION
Pharmacopoeia Clinical Trial Bioequivalence (BE)
Monthly Recap: China Pharmaceutical Regulatory Updates | November 2023 Check out the latest pharma regulatory updates in China.
Nov 30, 2023
REGULATION
Law & Regulation Pharmacopoeia CMC Clinical Trial Bioequivalence (BE) Generic Drug Biological Product New Drug GSP
Monthly Recap: China Pharmaceutical Regulatory Updates | October 2023 China pharma regulatory updates for Oct 2023: 1. NMPA Enforces Regulation on API Registration Renewal; 2. NMPA Tightens Regulation on Outsourced Manufacturing for MAHs; 3. NMPA and NHC Announce Chinese Pharmacopoeia 2020 Edition’s 1st Addendum; 4. NMPA Requires ANDAs Without RLDs to Demonstrate Clinical Value...
Nov 08, 2023
REGULATION
Law & Regulation MAH GMP
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
Law & Regulation DMF API Drug Registration
China Enforces Regulation on API Registration Renewal On Oct. 13, 2023, China NMPA implemented the Notice of the Administration of Active Pharmaceutical Ingredient (API) Registration Renewal, which applies to APIs that have obtained approval numbers or approval notifications.
Oct 18, 2023
REGULATION
Reference Listed Drug (RLD) Clinical Trial Bioequivalence (BE) Generic Drug
China Requires ANDAs Without Reference Drugs to Demonstrate Clinical Value For generic candidates without reference listed drugs, China's NMPA requires the applicant to conducting CM) studies to prove the proposed generic drug’s equivalence to the marketed drug with the same API, assesses and demonstrates the proposed drug’s clinical value, and submits a communication application for having a type-III meeting with CDE.
Oct 17, 2023
REGULATION
Pharmacopoeia
Chinese Pharmacopoeia 2020 Edition's 1st Addendum: 54 Additions and 607 Revisions On Oct.13, 2023, China’s NMPA and NHC jointly announced the release of the first Addendum to the Chinese Pharmacopoeia 2020 Edition. It was stated that the Addendum has been compiled and is planned to be implemented on March 12, 2024.
Oct 13, 2023
REGULATION
Law & Regulation Guideline Pharmacopoeia Innovative Drug Generic Drug Rare Disease Cell Therapy Gene Therapy
Monthly Recap: China Pharmaceutical Regulatory Updates | September 2023 China pharma regulatory updates in Sept. 2023: 1. NMPA Publishes the 2022 China Drug Evaluation Report; 2. NHC Releases the 2nd Catalog of Rare Diseases; 3. NMPA Adjusts Anesthetic and Psychotropic Drug Catalogs; 4. CDE Unveils 2022 Report on the Progress of New Drug Clinical Trials in China; 5. NMPA Grants Three Rx-to-OTC Switches; 6. ICH, NMPA, and CDE Release Pharmaceutical Guidelines; 7. Chinese Pharmacopoeia Commission Consults on Drafts of Drug Standards
Oct 08, 2023
REGULATION
Reference Listed Drug (RLD) Bioequivalence (BE) Generic Drug
China to Dismiss Overdue Equivalence Evaluation Applications for Generics On Sept. 25, 2023, China CDE released the draft of the Guidance for the Acceptance Review of Quality and Therapeutic Equivalence Evaluation Applications for Generic Drugs, stating that the CDE will no longer accept equivalence evaluation applications for generic drugs of the same type if they are submitted three years or more after the first generic drug passes the equivalence evaluation.
Sep 28, 2023
REGULATION
Law & Regulation
China Adjusts Anesthetic and Psychotropic Drug Catalogs On Sept. 11, 2023, China’s National Medical Products Administration (NMPA), Ministry of Public Security, and National Health Commission (NHC) adjusted the Catalogs of Anesthetics and Psychotropic Drugs.
Sep 12, 2023
REGULATION
Law & Regulation MAH Marketing Approval Clinical Trial Post-market Drug Registration
[Draft Regulation] China to Become Stricter on Conditional Approval of Drugs On Aug. 25, 2023, China National Medical Products Administration (NMPA) released the revised draft of Work Process for Conditional Approval of Drug Marketing Authorization Applications (Trial).
Sep 11, 2023
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