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Comprehensive coverage on the latest pharmaceutical regulatory update and industry activities in China.
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REGULATION
Law & Regulation
Guideline
Pharmacopoeia
Reference Listed Drug (RLD)
GMP
CMC
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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
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