On December 11, 2023, China’s Center for Drug Evaluation (CDE) announced important updates regarding the electronic submission of drug registration applications. These updates are compiled into the Technical Requirements for Compact Disks Containing Application Dossiers and Electronic Common Technical Document (eCTD) Structure. In addition, CDE has also introduced the eCTD Validation Criteria as a regulatory document. These three documents will come into effect on March 1, 2024.
1. Regulatory Updates on Electronic Submission
Table: Regulatory updates on electronic submission of drug registration applications in China
Regulatory document | Updated content |
Technical Requirements for Compact Disks Containing Application Dossiers | (1) Specifying the rules for coding application numbers and obtaining application numbers, and adding application numbers for active pharmaceutical ingredients (APIs), excipients, and packaging materials; (2) Providing detailed requirements for electronic submission media—stipulating that the data should be stored on a write-once standard 120-archive-grade compact disks without the option for rewriting; (3) Including the software (optional) for creating electronic application and the verification of submitted application, etc. |
Electronic Common Technical Document (eCTD) Structure | (1) Improving the specifications for files and folder extensions; (2) Offering detailed specifications for each application item and fixing the folder structure and path for each item; (3) Introducing a “Clinical Database Folder”, and defining the document structure specifically for pharmaceutical excipients and packaging materials in electronic submission. |
Regulatory document | Main content |
eCTD Validation Criteria | This document mainly includes three parts: (1) Basic information; (2) File/folder; (3) Integrity. If the validation of electronic application results in a severity level of “error”, the application will not pass the validation. |
2. Compact Disks Required
The applicant should submit a complete set of compact disks (including the clinical trial database, if applicable) for review by CDE.
With the exception of clinical trial applications, registration renewal application for overseas-manufactured drugs, and supplemental applications directly seeking administrative approval, the applicant must also submit a complete set of compact disks (including the clinical trial database, if applicable) for inspection by the Center for Food and Drug Inspection (CFDI) of National Medical Products Administration (NMPA).
For the inclusion of the clinical trial database, if applicable, it should be included in a dedicated set of compact disks. However, for documents related to generic name verification, suitability review for OTC drugs, and the review of medication package inserts, a dedicated set of compact disks is not required.
3. Acceptance of Applications in Electronic Submission
Upon receiving the compact disks submitted by the applicant, CDE will conduct a validation process in accordance with the eCTD Validation Criteria.
Only those compact disks that successfully pass the validation will be permitted to proceed to the subsequent revie process. Any compact disks that failed the validation will be securely discarded and destroyed.
Contact BaiPharm if you would like to learn more about drug registration in China.
