China NMPA Releases the 52nd List of RLDs
On March 11, China NMPA released the 52nd List of Reference Listed Drugs (RLDs). The list covers 52 drugs, including Abbott's Complex Packing Estradiol Tablets/Estradiol and Dydrogesterone Tablets, as well as Merck's Bisoprolol Fumarate and Amlodipine Besylate Tablets.1CDE Consults on Procedures for Adjusting the RLD List
On March 11, CDE published the draft of Procedures for Adjusting the Released Reference Listed Drugs for public comments. Up to date, there are 4,849 RLDs in the Catalog of Reference Listed Drugs. The RLDs are selected as reference products to which new generic drugs are compared to demonstrate bioequivalence. However, a RLD may be delisted for any one of the problems:- The RLD has been disqualified from marketing authorization or withdrawn from the market due to risks in safety, efficacy, or quality control.
- The RLD does not comply with the requirements of the current Chinese Pharmacopoeia or the technical review.
- Its RLD status was gained by submitting false information or it has problems in quality control.
- An enterprise/industry association or CDE proposes the adjustment;
- An expert panel discusses the adjustment;
- CDE publishes the discussion result within 60 workdays after receiving the proposal; the result will remain public for 10 workdays;
- If there is no dissent from the result, the adjustment will be approved and announced by NMPA.2
China NMPA Consults on Drug MAH's Inspection Regulation
On March 11, NMPA published the draft of Key Points in the Inspection of Drug Marketing Authorization Holder for public comments. The Key Points applies to domestic MAHs that entrust manufacturing to another company, and is also a reference for domestic MAHs that produce drugs by themselves. The inspection covers various aspects, including personnel, manufacturing equipment, drug labels, storage, documents & records, etc.3 RELATED: China's Marketing Authorization Holder (MAH) System.China NMPA Consults on Drug Delivery Regulation
On March 22, NMPA released the draft of Good Supply Practice for Pharmaceuticals Products—Appendix on the Quality Management in the Delivery of Retailed Drugs. The Appendix requires drug suppliers to provide appropriate packaging and transport services for the delivery of drugs sold online and offline, and ensure the delivery information is traceable.4China NHC Adds Paxlovid to COVID-19 Diagnosis and Treatment Protocol
On March 15, China's National Health Commission added Pfizer's Paxlovid to the Diagnosis and Treatment Protocol for COVID-19 Pneumonia (9th Trial Version).5 On March 23, NHC adjusted Paxlovid's indication in the Protocol to the treatment of mild-to-moderate COVID-19 in adult patients who have the risk of developing into severe conditions.6China Starts to Adopt COVID-19 Antigen Self-tests
On March 11, NHC released the Plan for Adopting COVID-19 Antigen Tests (Trial), marking the first time that China has permitted the public use of COVID-19 antigen self-test kits. The kits are allowed to be sold at drug retailers and online pharmacies. 21 domestically-made antigen self-test kits have been approved by China NMPA as of March 30.7Medical Device-related Regulations
- China NMPA to Implement New GCP of Medical Devices
- China SAMR to Enforce New Measures for Supervising the Manufacturing of Medical Devices
- China SAMR to Enforce New Measures for Supervising the Supply of Medical Devices
- China NMPA Adjusts the Medical Device Classifications
- NMPA Issues Guidance for Annual Self-inspection Report on QMS of Medical Devices
- comprehensive information (registrant/filer's info, entrusted company's info, etc);
- major changes (changes to functions, manufacturing sites, etc.);
- performance of QMS system (personnel, quality control, etc.).
- NMPA Releases the Negative List of Medical Devices for Manufacturing Entrustment
- NMPA Approves 198 Medical Devices
