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Comprehensive coverage on the latest pharmaceutical regulatory update and industry activities in China.
INDUSTRY
Marketing Approval Innovative Drug Diabetes Drug Registration New Drug
[Updated] GLP-1-RAs Swoop to Chinese Market, Eyeing Diabetes Treatment & Weight Control Needs On July 25, 2023, China National Medical Products Administration (NMPA) approved Beinaglutide Injection (Feisumei), a glucagon-like peptide-1 receptor agonist (GLP-1-RA), for weight loss.
Aug 23, 2023
POLICY
Drug Registration Thailand
Thai FDA Expedites Drug Import Via Digital Channel On Aug. 17, 2023, Thai Food and Drug Administration (FDA) announced the policy for expediting the import of healthcare products, including drugs, medical devices, food, and cosmetics, with the aid of a digital service.
Aug 18, 2023
REGULATION
Law & Regulation MAH GMP Post-market
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
Law & Regulation GMP
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
INDUSTRY
Marketing Approval Priority Review Generic Drug Diabetes Drug Registration New Drug
Monthly Report: New Drug Approvals in China | July 2023 In July 2023, China NMPA approved 5 new drugs, among which 3 are chemical drugs and 2 are biological products.
Aug 03, 2023
REGULATION
Law & Regulation Clinical Trial Medical Device
[Updated] China Exempts Eligible Medical Devices and IVD Reagents from Clinical Evaluation or Trials On July 24, 2023, China NMPA announced the revised List of Medical Devices Exempted from Clinical Evaluation (2023) with immediate effect.
Jul 27, 2023
REGULATION
Law & Regulation Pharmacopoeia Reference Listed Drug (RLD) CMC Clinical Trial Generic Drug OTC Drug Cell Therapy New Drug GLP
[Updated] 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
Law & Regulation Clinical Trial
China Clarifies Human Genetic Resource (HGR)'s Definition and Foreign Stakeholders' Scope in New Rules 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
Law & Regulation Pharmacopoeia Marketing Approval Post-market Drug Registration
What Marketing Authorization Holders (MAHs) Should Do About China Drug Standards On July 5, 2023, China National Medical Products Administration (NMPA) issued the Administrative Measures for Drug Standards, which will take effect on the first day of 2024.
Jul 11, 2023
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