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Monthly Recap: China Pharmaceutical Regulatory Updates | August 2022
Check out China's pharmaceutical regulatory updates in August: NMPA granted OTC status to Omeprazole Enteric-coated Tablets; NMPA released the 57th List of Reference Listed Drugs (RLDs); NHC Adds Azvudine to COVID-19 Diagnosis and Treatment Protocol; NMPA to Adopt ICH E8 (R1) and E14 Guidelines...
Sep 09, 2022
REGULATION
Monthly Recap: China Pharmaceutical Regulatory Updates | July 2022
Check out the pharma regulatory updates in China: The 7th National Volume-based Procurement (VBP) Includes 327 Drug Products; China CDE Consults on Procedures for Starting For-cause Inspections; China CDE Releases Q&A on Immediate Report of Adverse Drug Reactions in Clinical Trials...
Aug 05, 2022
REGULATION
Chinese Pharmacopoeia Commission Consults on 46 Packaging Material Standards
Since June 10, 2022, the Chinese Pharmacopoeia Commission has issued the drafts of 46 pharmaceutical packaging standards according to the plan for compiling the Chinese Pharmacopoeia 2025 Edition. The Commission is currently collecting public advice and comments on the drafts until Sept 1, 2022.
Jul 21, 2022
REGULATION
Chinese Pharmacopoeia Commission Seeks Public Advice on Colorant Standards
The Chinese Pharmacopoeia Commission is currently asking for public advice on colorant standards. The target colorants include but are not limited to colorants used in pediatric drugs, or widely used in pharmaceuticals, or whose current quality control standards are incomplete, especially for operation, and whose current standards cannot meet the need for medical use.
Jul 18, 2022
REGULATION
Monthly Recap: China Pharmaceutical Regulatory Updates | June 2022
Check out the pharmaceutical regulatory updates in China: 1.CDE Issues the 2021 China Drug Evaluation Report; 2. CDE Publishes the 2021 Clinical Trial Report; 3. CDE Consults on Communication Procedures for Pediatric Drug Applicants...
Jul 06, 2022
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Monthly Recap: China Pharmaceutical Regulatory Updates | May 2022
Check out the May updates on pharma regulations in China: NMPA publishes MedDRA Coding Guidance for ADR Reports...
Jun 08, 2022
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