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.

Contents

1. China NMPA Issues New Administrative Measures for Drug Recall

2. China NMPA Temporarily Extends Deadlines for Submitting Supplemental Documents

3. China NMPA Consults on GLP Certification Regulation

4. China NMPA Releases the 61th List of RLDs

5. China NMPA to Issue Electronic Certificates and Approval Documents

6. CDE Issues a Series of Guidelines and Rules

7. ChP Commission Seeks Public Advice on Drug Standards

1. China NMPA Issues New Administrative Measures for Drug Recall

On Oct. 26, China NMPA issued the New Administrative Measures for Drug Recall, which took effect on Nov. 1, 2022. Different from the previous version issued in 2007, the new Measures designate drug marketing authorization holders (MAHs), instead of manufacturers, as the main responsible entity for drug recall.

MAHs are required to establish the drug recall system, collect drug quality and safety information, investigate and evaluate potential quality issues and/or other safety risks, and recall the drugs with the issues and risks. Read BaiPharm’s report on drug recall requirements.

2. China NMPA Temporarily Extends Deadlines for Submitting Supplemental Documents

For deficient drug registration applications, NMPA will issue deficiency letters that require applicants to submit supplemental documents. On Oct. 14, China NMPA announced it would temporarily extend the deadlines for the submission.

3. China NMPA Consults on GLP Certification Regulation

On Oct. 21, NMPA issued the draft of Administrative Measures for Good Laboratory Practice (GLP) Certification for public comments. GLP certification means that NMPA inspects and evaluates whether research institutes comply with GLP during non-clinical safety evaluation for pharmaceuticals. To learn about how to apply for GLP certification, please refer to BaiPharm’s report.

4. China NMPA Releases the 61st List of RLDs

On Oct. 20, NMPA releases the 61st list of 57 reference listed drugs (RLDs), including Biogen’s Nusinersen Sodium Injection and Takeda’s Maribavir Tablets. RLDs are drugs that generic drugs shall be equivalent to in quality and therapeutic efficacy. View the RLD details at BaiPharm Database; learn about generic drug registration application (ANDA) requirements at BaiPharm Insight.

5. China NMPA to Issue Electronic Certificates and Approval Documents

[Read more at ChemLinked]

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