Monthly Recap: China Pharmaceutical Regulatory Updates | April 2022

by Grace Wang May 05, 2022

1. China NMPA Announces Key Points for Pharmacovigilance Inspections

On April 15, China NMPA issued the Pharmacovigilance Inspection Guidelines with immediate effect. The Guideline applies to inspections for pharmacovigilance activities conducted by the marketing authorization holder (MAH) of an approved drug or by an entrusted third party.1 View the categories of pharmacovigilance inspection items.

2. China NMPA Implements New Rules on Drug MAH's Annual Reports

On April 12, China NMPA started implementing the Administrative Rules on Drug Annual Reports. The Rules mandates that MAHs of NMPA-approved drugs should submit annual reports to the online system—Drug Annual Report Collection Module.2 View the MAH annual report requirements.

3. China NMPA Releases the 53rd RLD List

On April 24, China NMPA released the 53rd list of reference listed drugs (RLD). The list covers 81 drugs, including Novartis' Ciclosporin Injection and Ipsen's Polyethylene Glycol Electrolytes Powder (III).3 RLDs are reference products for generic drugs to show equivalence in quality and therapeutic efficacy. View the RLD data at ChemLinked BaiPharm Database.

4. China NMPA Greenlights 181 Medical Devices

On April 8, China NMPA released the list of 181 medical devices it approved in March, including Boston Scientific's Left Atrial Appendage Closure Device and Dong Bang Medical's Cross-linked Hyaluronic Acid Gel for Injection.4

5. China CDE Consults on Work Procedures for Adding Pediatric Information to Drug Labels

On April 21, China Center for Drug Evaluation (CDE) released the draft of Work Procedures for Adding Pediatric Information to the Labels of Approved Drugs for public comments. There are two ways for adding the information.

One is that the National Pediatric Professional Association or the National Pediatric Medical Center sends a proposal to CDE. The other is that the pharmaceutical company of an approved drug submits a supplemental application to CDE. After receiving the above proposal/application, CDE will review them and decide whether to incorporate the pediatric information into the labels of corresponding drugs.5

6. Pharmaceutical Guidelines

No.

Guidelines

Authority

Status

Release

1

Technical Guidelines on CMC (Chemistry, Manufacturing, and Controls) Research and Evaluation of Biosimilars of Insulin Products

CDE

In force

April 1

2

Guidelines on Collecting Adverse Reaction Data for Antineoplastic Drugs Labels

CDE

In force

April 21

3

Guidelines on Bioequivalence Studies on Aspirin Enteric-coated Tablets

CDE

Consultation

April 28

4

Technical Guidelines on Drug Dependence Research

CDE

Consultation

April 18

5

Technical Guidelines on Clinical Research on Bispecific Antibodies as Antineoplastic Drugs

CDE

Consultation

April 11

6

Q&A about Dissolution Profile Research Conditions in the "Technical Guidelines on CMC Changes to Approved Drugs (Trial)”

CDE

Consultation

April 7

7

ICH E11A Guideline: Pediatric Extrapolation

CDE

Consultation

April 25

8

ICH Q2 (R2) Guideline: Validation of Analytical Procedures;

ICH Q14 Guideline: Analytical Procedure Development

CDE

Consultation

April 25

9

Technical Guidelines on CMC Research on Other Compound Preparations of TCMs (Traditional Chinese Medicine) from Ancient Classical Prescriptions

CDE

Consultation

April 28

10

Guidelines on Clinical Therapeutic Efficacy Evaluation of New TCMs for Chronic Gastritis;

Guidelines on Clinical Therapeutic Efficacy Evaluation of New TCMs for Gastroesophageal Reflux Disease

CDE

Consultation

April 29


Grace Wang
ChemLinked Regulatory Analyst
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