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Comprehensive coverage on the latest pharmaceutical regulatory update and industry activities in China.
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REGULATION
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
Monthly Recap: China Pharmaceutical Regulatory Updates | August 2023
China pharma regulatory updates in Aug 2023: 1. China Consults on Conditional Approval Process; 2. China Rolls out 71st and 72nd Lists of RLDs; 3. China Grants Two Rx-to-OTC Switches; 4. China Releases Pharmaceutical Guidelines; 5. China Consults on Drafts of Drug Standards
Sep 08, 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
Guideline
Pharmacopoeia
Reference Listed Drug (RLD)
GMP
CMC
Clinical Trial
Bioequivalence (BE)
Cell Therapy
Gene Therapy
Drug Registration
GLP
GSP
Monthly Recap: China Pharmaceutical Regulatory Updates | July 2023
China pharmaceutical regulatory updates in July 2023: 1. China Publishes Administrative Measures for Drug Standards; 2. China Announces Customs Codes of Anesthetics and Psychotropic Drugs; 3. China Rolls out the 70th RLD List; 4. China Grants Four Rx-to-OTC Switches; 5. China Revises Drug Inspection Regulation; 6. China Issues Draft Regulation on Inspection of Clinical Trial Institutions; 7. China Releases Pharmaceutical Guidelines; 8. China Consults on Drafts of Drug Standards
Aug 11, 2023
REGULATION
Drug Inspections of Manufacturers and Suppliers in China: Regulation Revised
China has cancelled the GMP and GSP certification since it implemented Drug Administration Law in 2019. Now, the drug manufacturing and supply activities in the country will be inspected according to Administrative Measures on Drug Inspection (Trial).
Aug 11, 2023
REGULATION
Law & Regulation
Pharmacopoeia
Reference Listed Drug (RLD)
CMC
Clinical Trial
Generic Drug
OTC Drug
Cell Therapy
New Drug
GLP
Monthly Recap: China Pharmaceutical Regulatory Updates | June 2023
Check out China's pharma regulatory updates in June 2023: 1. NMPA Announces Three Rx-to-OTC Switches; 2. NMPA Releases the 69th RLD List; 3. NMPA Specifies GLP Certification Requirements; 4. NMPA to Make Medication Package Inserts Friendlier to Senior Patients; 5. NMPA Revises Administrative Measures for Drug Inspection; 6. CDE Releases Nine (Three in Effect and Six in Consultation) Pharmaceutical Guidelines; 7. Chinese Pharmacopoeia Commission Consults on One Standard on the Generic Names of Pharmaceutical Packaging Materials
Jul 27, 2023
REGULATION
China Clarifies Human Genetic Resources (HGRs) and Foreign Stakeholders in International Clinical Researches
China’s Implementation Rules for the Administrative Regulations of Human Genetic Resources, declared by the Ministry of Science and Technology (MOST), took effect on July 1, 2023.
Jul 21, 2023
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