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Comprehensive coverage on the latest pharmaceutical regulatory update and industry activities in China.
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
Law & Regulation Clinical Trial
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
INDUSTRY
Marketing Approval Priority Review Innovative Drug Generic Drug Biological Product Cancer Diabetes Drug Registration New Drug
Monthly Report: New Drug Approvals in China | June 2023 In June 2023, China NMPA approved 33 new drugs, among which 26 are chemical drugs while 7 are biological products.
Jul 07, 2023
REGULATION
Law & Regulation GLP
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
INDUSTRY
Guideline CMC
BaiPharm Shares Insights into Computational Toxicology at CPHI China As CPHI China’s partner, BaiPharm staged a seminar “Application of Computational Toxicology in the Pharmaceutical Industry” which covers four sessions, each presented by experienced experts, on June 19, 2023.
Jun 25, 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
INDUSTRY
Marketing Approval Innovative Drug Generic Drug Biological Product Cancer Diabetes Vaccine Drug Registration New Drug
Monthly Report: New Drug Approvals in China | May 2023 In May 2023, China NMPA approved 27 new drugs, among which 16 are chemicals and 11 are biologics: 1. Betta Pharma’ Befotertinib Mesylate Capsules; 2. Sanhome Pharma’s Alfosbuvir Tablets; 3. Novartis’ Ribociclib Succinate Tablets...
Jun 12, 2023
REGULATION
Law & Regulation Clinical Trial GCP US
U.S. FDA Announces Draft E6 (R3) Guideline for Good Clinical Practice (GCP) On June 6, 2023, U.S. FDA released the draft E6 (R3) Guideline for Good Clinical Practice for public comments. The draft is open to public comments until June 9, 2023.
Jun 07, 2023
REGULATION
Law & Regulation Post-market Drug Registration Pediatric Drug
China Outlines Path for Adding Pediatric Medication Information to Authorized Drugs On May 31, 2023, China NMPA released the Work Procedures for Adding Pediatric Information to Medication Package Inserts of Authorized Drugs (Trial) with immediate effect.
Jun 07, 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
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