China to Accept eCTD Format for Marketing Authorization Applications for Specific Classes of Drugs

by Grace Wang Oct 14, 2021

The National Medical Products Administration (NMPA) recently announced that it would start to accept the electronic common technical document (eCTD) format for drug applications on Dec. 29, 2021.1

NMPA still allows drug applicants to stay with the current method—submitting compact disks containing dossiers.

eCTD Application Scope in China

The NMPA announcement marks China's first move towards promoting eCTD format for drug marketing authorization applications.

In the initial stage, the eCTD format is applicable to applications for Class 1 and Class 5.1 chemical drugs, Class 1 therapeutic biological products and Class 1 prophylactic biological products. 

These products are all innovative medical products, which are supposed to have sufficient research data for supporting marketing authorization. Such data is considered more appropriate for the eCTD format. Therefore, China currently only permits these products to use the new format.

Also, it is common that marketing authorization applications for innovative drugs are submitted to regulators in different countries and regions in the meantime. In such cases, adopting the eCTD format to keep consistency would spare applicants from preparing documents in various formats.

The new eCTD format is NOT mandatory, so the stakeholders can still choose the current registration method.

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.

Notes:

For applicants choosing the eCTD format, applicants are not required to submit the two compact disks, one for data for verification and inspection, the other for database of clinical trials.

The eCTD format is not mandatory and the current registration method of submitting compact disks to CDE (Center for Drug Evaluation) is also acceptable.

 

eCTD Requirements in China

For stakeholders who choose to submit applications in eCTD format, they shall prepare documents according to NMPA's eCTD Technical Standards V1.0, eCTD Verification Standards V1.0, eCTD Implementation Guidance V1.0, and eCTD Technical Standards V1.0 Appendices.

Applicants shall submit compact disks containing the relevant eCTD documents to CDE. When the eCTD documents get accepted by CDE, applicants shall submit the paper documents within five workdays. Otherwise, the drug registration process would be terminated by CDE. The eCTD documents and the paper ones shall be consistent in content.

Besides obeying NMPA's eCTD requirements, applicants shall also refer to the following documents, says NMPA's eCTD Technical Standards V1.0.

Many of the documents are formulated by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). The reason is that, as an ICH member, NMPA intends to keep aligned with ICH standards and guidelines.

Documents for Reference on eCTD Dossiers

1. ICH eCTD Specification and Related Files

2. ICH Electronic Common Technical Document Specification V3.2.2

3. ICH The eCTD Backbone File Specification for Study Tagging Files V2.6.1  

4. ICH Specification for Submission Formats for eCTD V1.2

5. ICH eCTD IWG Question and Answer and Specification Change Request Document V1.31

6. ICH E3 Structure and Content of Clinical Study Reports

7. M4 Module 1: Administrative Documents and Drug Information

8. Guidelines for Submitting Drug Clinical Trial Data (Trial)

As a medical products compliance service provider, ChemLinked BaiPharm is supported by experienced professionals capable of preparing eCTD documents with authorized software. Welcome to contact ChemLinked BaiPharm via contact@chemlinked.com.

Grace Wang
ChemLinked Regulatory Analyst
+ FOLLOW
Copyright: unless otherwise stated all contents of this website are ©2022 - REACH24H Consulting Group - All Rights Reserved - For permission to use any content on this site, please contact cleditor@chemlinked.com