Sept 2022 | China Pharmaceutical Regulatory Updates

Oct. 11th, 2022
1611

This is a collection of China’s recent pharmaceutical laws, regulations, policies, and standards, mainly issued by the following authorities:

  • National Medical Products Administration (NMPA);
  • NMPA’s Center for Drug Evaluation (CDE);
  • National Health Commission (NHC);
  • National Healthcare Security Administration (NHSA);
  • National Joint Drug Procurement Office;
  • Chinese Pharmacopoeia (ChP) Commission.

For more details about the summarized contents below, please send an enquiry to customer@reach24h.com.

pharmaceutical regulation chin

Contents


  1. China SAMR to Permit Online Sales of Prescription Drugs Nationwide
  2. China NMPA Grants One Rx-to-OTC Switch
  3. China NMPA Releases 183 RLDs
  4. China CFDI Consults on Inspection Guidance for Blood Products
  5. China NHSA Announces 343 Drugs Passing the Format Review for NRDL
  6. China CDE Releases Pharmaceutical Guidelines
  7. Chinese Pharmacopoeia Commission Consults on Drafts of Drug Standards and Guideline

1. China SAMR to Permit Online Sales of Prescription Drugs Nationwide


On Sept. 1, 2022, China State Administration for Market Regulation (SAMR) published the Administrative Measures for Supervising Online Sales of Drugs (hereafter referred to as the Measures), which will be enforced from Dec. 1, 2022. The Measures is the first official regulation that has permitted online sales of prescription (Rx) drugs nationwide.

To ensure the safety for selling drugs online, the Measures specifies regulatory requirements for online sellers and third-party online platforms. For example, online sellers are only allowed to sell prescription drugs to customers who show reliable and authentic prescriptions with their real names. For more details, please refer to BaiPharm’s previous report.

2. China NMPA Grants One Rx-to-OTC Switch


On Sept. 20, China National Medical Products Administration (NMPA) granted OTC status to Santongshu Capsules, a former prescription drug. It is a traditional Chinese medicine (TCM) for relieving muscle pain. By far, 806 prescription drugs have obtained OTC status via Rx-to-OTC switches. Check China’s OTC Drug Catalog at BaiPharm Database.

Related Article: How to Get China’s Marketing Authorization for OTC Drugs

3. China NMPA Releases 183 RLDs


On Sept. 14, Sept. 27, and Sept. 30, China NMPA released the 58th, the 59th, and the 60th lists of reference listed drugs (RLDs) separately, altogether including 183 drugs. RLDs are reference drugs for evaluating generic drugs—generics should be equivalent to RLDs in quality and therapeutic efficacy. Check out China’s RLD Catalog at BaiPharm Database.

Related Webinar: China’s Quality and Therapeutic Equivalence Evaluations of Generic Drugs

4. China CFDI Consults on Inspection Guidance for Blood Products


[Read more at ChemLinked]

Reference Links


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