Monthly Recap: China Pharmaceutical Regulatory Updates | Sept. 2021

by Grace Wang Oct 31, 2021

Editor's Note: Monthly recap is a brief collection of recently-issued drug laws, regulations and policies in China, especially those issued by National Medical Products Administration (NMPA) and its affiliating office Center for Drug Evaluation (CDE).

1. eCTD Format for Drug Marketing Application Dossiers

NMPA will start to accept the electronic common technical document (eCTD) format for drug application dossiers on Dec. 29, 2021.1 Currently, the eCTD format is only applicable to Class 1 and Class 5.1 chemical drugs, and Class 1 therapeutic and prophylactic biological products.

The format is NOT mandatory but alternative, so drug applicants can stay with the current method—submitting compact disks containing dossiers. Read more about the eCTD requirements.

China eCTD Application Scope:

Marketing Authorization Application Dossiers for Medical Products

Class 1 chemical drug: An innovative chemical drug that has never been granted marketing authorization in or outside China.

Class 5.1 chemical drug: An innovative or improved chemical drug with overseas marketing authorization and applying for marketing authorization in China. The improved drug shall have distinct clinical advantages.

Class 1 therapeutic biological product: An innovative therapeutic biological product that has never been granted marketing authorization in or outside China.

Class 1 prophylactic biological product: An innovative vaccine that has never been granted marketing authorization in or outside China.

2. Medical Device or IVD Reagent Regulations

2.1. NMPA Underlines Points for Attention on Implementing Administrative Measures for Medical Device Registration and Filing and Administrative Measures for In Vitro Diagnostic Reagent Registration and Filing.

Before the two measures took effect on Oct. 1, 2021, NMPA pointed out noteworthy items on Sept. 29.2

For medical devices under the review but not yet approved before the implementation of the two measures, NMPA will continue the review and grant qualified devices according to the previous regulations.

For medical devices involving biological testing in their biological evaluation, the biological testing report shall be submitted with the marketing authorization application. If the report is from laboratories outside China, the applicant shall provide quality assurance documents proving that the laboratory complies with Good Laboratory Practice (GLP) requirements.

Medical devices imported to China shall be registered/filed by overseas registration/filing applicants. Medical devices manufactured by international companies in China shall be registered/filed by Chinese manufacturers.

2.2. NMPA Rolls Out the List of Medical Devices Exempted from Clinical Evaluation3 and the List of In Vitro Diagnostic Reagents Exempted from Clinical Trials4

The two lists, both released by NMPA on Sept. 18, allow stakeholders to spare themselves from conducting clinical evaluation/trials if the products are eligible for exemption.

A total of 1,010 categories of Class II/Class III medical devices and 423 categories of Class II/Class III IVD reagents are exempted from clinical evaluation or trials. Click here for exemption conditions and corresponding submission requirements.

2.3. NMPA Releases Format Requirements for Medical Devices' or IVD Reagents' Registration Application Dossiers and Approval Documents

Grace Wang
ChemLinked Regulatory Analyst
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