Monthly Recap: China Pharmaceutical Regulatory Updates | October 2022

by Grace Wang Nov 02, 2022

Editor's Notes: Monthly recap 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.


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 designates 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.1 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.2

Provisional Extensions of Deadlines for Submitting Drug Registration Applications' Supplemental Documents

Date of the Deficiency Letter Issuance by NMPA

Whether the Current Date Is Before the Previous Deadline

Extended Deadline

Before Oct. 14, 2022

No

80 workdays after Oct. 14, 2022

Before Oct. 14, 2022

Yes

80 workdays after the previous deadline

Between Oct. 14, 2022 and Dec. 31, 2022

/

160 workdays after the deficiency letter issuance date

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.3 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.4 RLDs are drugs which 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

From Nov. 1, 2022, NMPA will issue drug registration certificates in electronic version, which is as valid as the paper version.5 Electronic drug registration will cover:

Ÿ   Clinical trial approval certificate

Ÿ   Marketing authorization certificate

Ÿ   Re-registration certificate (for registration renewal)

Ÿ   Supplemental application approval certificate

Ÿ   Traditional Chinese medicine (TCM) protection certificate

Ÿ   Imported raw ingredient certificate

Ÿ   Certificate for active pharmaceutical ingredient (API) of chemical drug

Ÿ   Good laboratory practice (GLP) certificate

Read BaiPharm's report to know how to download the certificates.

From the same date, the following two documents will only be issued in electronic version:

Ÿ   Certificates for lot release of biological products;

Ÿ   Approval documents for anesthetic and psychiatric drug research projects.6

The electronic certificates and approval documents are downloadable at NMPA's online service platform and mobile app "中国药监".

6. CDE Issues a Series of Guidelines and Rules

The following list shows the guidelines and rules issued by CDE in October 2022.

No.

Guidelines/Rules

Status

Release Date

Enforcement Date

1

Technical Guidelines on Bioequivalence of Aspirin Enteric-coated Tablets

In force

Oct. 9

Oct. 9

2

Guidelines on Identifying, Handling, and Evaluating Drug-induced Liver Injury During Clinical Trial

Draft

Oct. 8

/

3

Technical Guidelines on Clinical trials for Therapeutic Cancer Vaccines

Draft

Oct. 9

/

4

Technical Guidelines on Designing Clinical Trials for Human Gene Therapy for Hemophilia

Draft

Oct. 9

/

5

Technical Guidelines on Microbial Limit of Non-sterile Chemical Drugs, Active Ingredients, and Excipients

Draft

Oct. 10

/

6

Technical Guidelines on Clinical Trials for Therapeutic Drugs for Chronic Hepatitis B  

Draft

Oct. 25

/

7

Technical Guidelines on Chemical Synthetic Peptide Drugs' CMC (Chemistry, Manufacturing, and Control) Researches

Draft

Oct. 25

/

8

Technical Guidelines on Clinical Safety Evaluation of New Drugs

Draft

Oct. 25

/

9

Technical Guidelines on Clinical Trials for Human Papillomavirus (HPV) Vaccines

Draft

Oct. 26

/

10

Work Rules for Reviewing Drug Clinical Trial Protocols

Draft

Oct. 27

/

7. ChP Commission Seeks Public Advice on Drug Standards

On Oct. 25, the Chinese Pharmacopoeia (ChP) Commission announced it would collect advice on the standards of sterilization and microbial limit tests for pharmaceutical excipients until Nov. 20, 2022. The relevant excipients7 include but are not limited to

Ÿ   excipients in the Chinese Pharmacopoeia

Ÿ   excipients used with a large quantity in finished drug products

Ÿ   excipients which are water-insoluble, highly viscous, highly hydroscopic, bacteriostatic, and/or easy to diffuse and swell

Ÿ   excipients whose microbial limits are questionable

In addition, the ChP Commission released the below drug standards drafts for public comments.

No.

Drafts of Drug Standards

Product Category

Release Date

1

Monograph: Arginine Hydrochloride

Excipient

Oct. 9

2

Monograph: Thiourea

Excipient

Oct. 25

3

Monograph: Tributyl Phosphate

Excipient

Oct. 26

BaiPharm provides China pharmaceutical regulatory information, compliance services, and marketing solutions. Please contact us if you need more details of the summarized contents above.

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Grace Wang
ChemLinked Regulatory Analyst
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