Monthly Recap: China Pharmaceutical Regulatory Updates | May 2022

by Grace Wang Jun 08, 2022

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. China NMPA Releases the 54th RLD List

On May 19, NMPA released the 54th list of reference listed drug drugs. The list covers 61 drugs, including Zionexa's Fluoroestradiol 18F Injection and Eli Lilly's Lasmiditan Tablets. RLDs are reference products with which generic drugs are equivalent in quality and therapeutic efficacy Find out more RLD data at ChemLinked BaiPharm Database.

2. China NMPA Grants Two Rx-to-OTC Switches

On May 20, NMPA granted two traditional Chinese medicines—Tiaojing Yangyan Granules and Fubaokang Gel—with OTC status. Check more OTC drugs at ChemLinked BaiPharm Database.

3. China Publishes MedDRA Coding Guidance for ADR Reports

On May 6, 2022, China National Center for ADR Monitoring released the MedDRA Coding Guidance for Drug Marketing Authorization Holders (MAH). The Guidance is for MAHs to use MedDRA coded terms in post-marketing adverse reaction reports accordingly.

4. China NMPA Consults on Regulations for Implementation of the Drug Administration Law

On May 9, NMPA released the revised draft of Regulations for Implementation of the Drug Administration Law for public comments. Compared to the 2016 revised version, the draft of the 2022 version includes 101 more articles, newly covering marketing authorization holder system, patent protection, and pharmacovigilance, etc.

5. China NMPA Specifies GMP Regulations on Investigational Drugs Used in Clinical Trials

On May 27, NMPA released the Appendix to Good Manufacturing Practice (GMP) of Pharmaceuticals: Investigational Drugs Used in Clinical Trials, which will take effect on July 1, 2022. The appendix gives detailed GMP requirements for the preparation of investigational drugs.

6. China NMPA to Renew Medical Sodium Hyaluronate's Administrative Classifications

On May 20, NMPA started soliciting public opinions on the revised draft of the Announcement on the Administrative Classifications of Sodium Hyaluronate Products for Medical Use. The draft renews the classification system of medical sodium hyaluronate products according to their intended uses and mechanisms of action.

7. Medical Device Regulations

7.1 China NMPA Greenlights 212 Medical Devices

On May 16, NMPA granted marketing authorization to 212 medical devices, including Covidien's Ticron Coated Braided Polyester Nonabsorbable Suture and Lake Region Medical's Safari²™ Guidewires.

7.2 China NMPA Implements 55 Industry Standards for Medical Devices

On May 20, NMPA released 55 industry standards for medical devices, including YY 0307-2022 Laser Therapy Devices: Yttrium Aluminium Garnet (YAG) Laser Therapy Device, and revised two medical device standards.

7.3 China NMPA Consults on Guidance for Pre-approval Inspections of Medical Device Quality Management Systems

On May 27, NMPA asked for public opinions on the revised draft of Guidance for Pre-approval Inspections of Medical Device Quality Management Systems (QMS). The Guidance applies to onsite inspections for Class II and III medical devices, with emphases on

  • QMS principles;

  • institution and personnel;

  • factories, facilities, and devices;

  • document management;

  • design and development;

  • procurement;manufacturing;

  • quality control;

  • entrusted manufacture;

  • product integrity (the product data is in accordance with to the manufacturing record, testing record, etc.)

8. Pharmaceutical Guidelines

No.

Guidelines

Authority

Status

Release

1

Technical Guidelines on the Evaluation of Immune-related Adverse Events (irADR) in Immuno-oncology

CDE

In force

May 17

2

Writing Guidance for and Templates of Medical Package Inserts of Chemical Drugs and Biological Products

CDE

In force

May 23

3

Technical Guidelines on the Clinical Evaluation of Intravenous General Anesthetics

CDE

In force

May 23

4

Technical Guidelines on CMC (Chemistry, Manufacturing, and Control) Research and Evaluation of Hyperimmune Globulins (HIG)

CDE

In force

May 25

5

Technical Guidelines on Clinical Trials of Locally Applied and Locally Acting Drugs

CDE

In force

May 25

6

Technical Guidelines on CMC Research and Evaluation of In Vitro Gene Modification Systems (Trial)

CDE

In force

May 31

7

Technical Guidelines on CMC Research and Evaluation of Immune Cell Therapy Products (Trial)

CDE

In force

May 31

8

Technical Guidelines on CMC Research and Evaluation of In Vivo Gene Therapy Products

CDE

In force

May 31

Upcoming Event

understanding-chinese-pharmacopoeia-chp-2020.pngCheck out ChemLinked BaiPharm webinar "Understanding Chinese Pharmacopoeia (ChP) 2020", which will take place on June 15. The webinar will talk about

  1. China National Drug Standard System

  2. Content of Chinese Pharmacopoeia (ChP) 2020

  3. How to Get Access to API & Excipient Standards of ChP 2020

Further Reading

Grace Wang
ChemLinked Regulatory Analyst
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