China drug registration electronic submission requirements updates have been made by the Center for Drug Evaluation (CDE) to enhance the quality and efficiency of electronic submission materials for drug registration applications. These updates, compared to the previous release on December 2, 2022, include the following significant modifications:
Technical Requirements for Electronic Submission Materials:
- Introduction of Section Six, outlining application number rules and acquisition methods.
- Refinement of Section Eight, providing details on electronic signatures.
- Addition of Section Eleven, where the CDE offers applicants free electronic submission material creation software.
Electronic Document Structure for Drug Registration Applications:
- The “Document Structure” has been significantly improved. This update provides a detailed breakdown of document structures based on different registration categories and submission material requirements. It ensures that applicants have a clear understanding of the required document structures.
Introduction of Electronic Submission Material Software and Validation Standards:
- New additions include the provision of “Electronic Submission Material Creation Software” and “Electronic Submission Material Validation Standards.” Applicants should follow the instructions in the “Electronic Submission Material Creation Software User Manual” for software installation.
- After installation, applicants can use the software to generate electronic submission materials that comply with the specified requirements.
- The “Electronic Submission Material Validation Standards” guide applicants in conducting a comprehensive self-check and validation of their submission materials on their computers.
- Specific types of drug applications not subject to site inspection, such as drug clinical trial applications, overseas drug production re-registration applications, and supplementary applications for direct administrative approval, applicants are required to submit a complete set of electronic submission material discs for verification purposes.
- In cases involving clinical trial database materials, a separate set of discs for clinical trial databases must be prepared.
- For matters related to generic name approval data, non-prescription drug suitability review, and package insert review, a separate disc submission is no longer required.
- Pharmaceutical excipients and packaging material registration data must comply with the requirements outlined in this communication.
The significance of these updates lies in their potential to help applicants improve the success rate of formal reviews, expedite the issuance of acceptance notifications, and avoid non-compliance issues by adhering to the specified electronic submission material formats and structures.
These changes are effective from March 1, 2024. In cases of any inconsistencies between this notice and the previous “Notice on Requirements for Electronic Submission of Drug Registration Applications,” this notice takes precedence.
Read the original CDE announcement on China drug registration electronic submission requirements updates.
Read our precious blog post on Electronic submission for China drug registration applications.
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