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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
Reference Listed Drug (RLD)
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CMC
Clinical Trial
Bioequivalence (BE)
Generic Drug
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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
Clinical Trial
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
Pharmacopoeia
MAH
Marketing Approval
CMC
Clinical Trial
Bioequivalence (BE)
NRDL
Drug Registration
New Drug
Real World Data
Packaging
Monthly Recap: China Pharmaceutical Regulatory Updates | February 2023
China's regulatory updates in Feb. 2023: 1. China NMPA Issues TCM Registration Rules; 2. China CDE Rolls Out Pharmaceutical Guidelines; 3. Chinese Pharmacopoeia Commission Issues Draft Standards
Mar 07, 2023
REGULATION
Monthly Recap: China Pharmaceutical Regulatory Updates | December 2022
Check out China's pharmaceutical regulatory updates in December 2022: 1. China NMPA Adds OTC Status to a Former Prescription Drug; 2. China NMPA Releases the 62nd List of RLDs; 3. China NMPA Issues Regulation on Supervising MAH as the Main Responsible Entity for Drug Safety; 4. China NMPA Requires Licenses for Importing and Exporting Anesthetics and Psychoactive Drugs; 5. China CDE Specifies Requirements for Electronic Submission of Drug Applications...
Jan 09, 2023
REGULATION
China Issues Draft Regulation on MAH as Main Responsibility Entity for Drug Quality
Drug marketing authorization holders (MAH) in China are required to establish drug quality management system and be responsible for the safety, effectiveness, and quality controllability during drug development, manufacture, supply, and use according to the Drug Administration Law, Good Manufacturing Practices (GMP), Good Supply Practices (GSP), Good Pharmacovigilance Practices (GVP), and relevant regulations.
Dec 16, 2022
REGULATION
Law & Regulation
Guideline
Pharmacopoeia
MAH
CMC
Clinical Trial
Bioequivalence (BE)
Innovative Drug
API
Drug Registration
E-commerce
Packaging
Excipient
Monthly Recap: China Pharmaceutical Regulatory Updates | November 2022
Check out China's Pharma Regulatory Updates for November 2022: 1. China NMPA Renews Classifications of Sodium Hyaluronate Products;
2. China NMPA Requires All Drug Registration Application Documents to Be Submitted in Compact Disks; 3. China NMPA Consults on Chemical API Registration Renewal Regulation, and more.
Dec 09, 2022
INDUSTRY
INDUSTRY
Top 10 CROs Using China's Human Genetic Resources in International Clinical Trials
From Jan. to Oct. 2022, among the 3,632 international clinical trials approved by China to use the its human genetic resources outside China, about 52% are conducted by contract research organizations (CROs) and about 48% by the applicants themselves.
Nov 23, 2022
REGULATION
Monthly Recap: China Pharmaceutical Regulatory Updates | October 2022
Find out the China's pharmaceutical regulatory updates in October: 1. China NMPA Issues New Administrative Measures for Drug Recall;
2. China NMPA Temporarily Extends Deadlines for Submitting Supplemental Documents;
3. China NMPA Consults on GLP Certification Regulation;
4. China NMPA Releases the 61th List of RLDs;
5. China NMPA to Issue Electronic Certificates and Approval Documents;
6. CDE Issues a Series of Guidelines and Rules;
7. ChP Commission Seeks Public Advice on Drug Standards.
Nov 02, 2022
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