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Comprehensive coverage on the latest pharmaceutical regulatory update and industry activities in China.
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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
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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
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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
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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
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
REGULATION
Law & Regulation
Guideline
Pharmacopoeia
CMC
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Volume-based Procurement
Cancer
Drug Registration
Monthly Recap: China Pharmaceutical Regulatory Updates | April 2023
Regulatory updates in Apr. 2023: 1. China Grants Four Rx-to-OTC Switches; China Adjusts Catalogs of Anesthetics and Psychoactive Drugs; China Reveals the 8th Medical VBP’s Bidding Result...
May 15, 2023
REGULATION
Monthly Recap: China Pharmaceutical Regulatory Updates | March 2023
China regulatory updates in Mar. 2023: 1. China NMPA Grants OTC Status to Two Former Prescription Drugs; 2. China NMPA Releases Two RLD Lists; 3. China NMPA Releases RLD Adjustment Procedures; 4. China CDE Trials Work Procedures for Expediting the Review of Innovative Drug’s Marketing Authorization Application; 5. China CDE Consults on Dossier Requirements for Moving the Manufacturing Site to China...
Apr 13, 2023
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