Editor's Notes: Monthly recap is a collection of recent pharmaceutical laws, regulations, and policies in China, 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.
1. 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.1
2. CDE 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The RLD has been disqualified from marketing authorization or withdrawn from the market due to risks in safety, efficacy, or quality control.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.
The adjustment procedures take place in the following order:
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
3. 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.
4. 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.4
5. China 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.6
6. China 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 30.7
7. Medical Device-related Regulations
7.1. China NMPA to Implement New GCP of Medical Devices
On March 31, China NMPA and NHC released the Good Clinical Practice (GCP) of Medical Devices, which will take effect on May 1, 2022. GCP applies to clinical trials and related activities for acquiring marketing authorization of medical devices (including in vitro diagnostic reagents, IVD) in China. According to GCP, an overseas applicant of clinical trials should designate a Chinese legal person as local agent to carry out obligations.8
7.2. China SAMR to Enforce New Measures for Supervising the Manufacturing of Medical Devices
On March 22, China State Administration for Market Regulation (SAMR) published the Administrative Measures for Supervising the Manufacturing of Medical Devices, which will take effect on May 1, 2022. The Measures requires that Class 2 and Class 3 medical device manufacturers in China shall apply for the manufacturing license, while Class 1 medical device manufacturers shall file records.9
RELATED: Medical Device Registration and Filing in China
7.3. China SAMR to Enforce New Measures for Supervising the Supply of Medical Devices
On March 22, SAMR rolled out the Administrative Measures for Supervising the Supply of Medical Devices whose implementation will start on May 1, 2022. According to the Measures, the supply license is required for class 3 medical device suppliers, record-filing is required for class 2 ones, and no need for license or filing for class 1 ones.10
7.4. China NMPA Adjusts the Medical Device Classifications
On March 24 and 30, NMPA adjusted 10 and 27 medical devices' classifications respectively. The involved medical devices include liquid dressings11 and radio frequency treatment devices12. Contact BaiPharm for the interpretation of detailed adjustments.
7.5. NMPA Issues Guidance for Annual Self-inspection Report on QMS of Medical Devices
Domestic and foreign medical device registrants and filers shall conduct self-inspection of the quality management system (QMS) every year and submit the self-inspection report before March 31 of the following year. The report should at least include three aspects13:
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 also provides the report templates. Contact BaiPharm for translating the templates.
7.6. NMPA Releases the Negative List of Medical Devices for Manufacturing Entrustment
On March 24, NMPA released the List of Medical Devices Banned from Manufacturing Entrustment, which will come into force on May 1. The List includes implantable pacemaker, intracranial stent system, breast implants, etc.14
7.7 NMPA Approves 198 Medical Devices
On March 14, NMPA released a list of medical devices that it had approved in February 2022. The list covers 198 medical devices, including Heraeus Medical's bone cement and Alcon Laboratories' Soft hydrophilic lens.15
8. Pharmaceutical Guidelines
No. | Guidelines | Authority | Release |
1 | CDE | March 14 | |
2 | CDE | March 11 | |
3 | Guidelines for Research on New Compound Traditional Chinese Medicines Based on Human Use | CDE | March 11 |
4 | CDE | March 11 |
For details of the pharmaceutical regulations above, welcome to consult BaiPharm via contact@chemlinked.com
