Drug registration in China for transferring the production of biological therapeutic products marketed abroad to in China manufacturing now has a clear set of guidelines. They were issued on June 14, 2024, by China’s Center for Drug Evaluation (CDE). This follows other recent guidelines on transferring production of chemical drugs.
Below we present the key requirements concerning biological therapeutics:
I. General requirements
- Marketing Registration: Domestic applicants must submit a marketing registration application when transferring the production of therapeutic biological products marketed overseas to China.
- Self-Assessment and Application: Applicants should conduct a self-assessment to determine if a clinical trial is necessary, and submit either a marketing authorization or a clinical trial application CDE encourages applicants to apply for communication and exchange meetings to discuss registration paths and related issues
- Application Dossier Format: The application should follow the ICH “M4: Common Technical Documents (CTD) for Registration of Human Drugs.” ensuring the catalogue and project numbers remain unchanged. For simplified or exempted information, it is necessary to indicate “not applicable” under the item and explain the reason. It is necessary to indicate the type of production transfer in the special declaration of the application form.
II. Simplified circumstances and application materials requirements
- Simplified circumstances: For drugs transferred to domestic production, it is recommended that all elements remain consistent with those before the transfer except for the holder, production site and testing site. This will simplify the application materials and review process. The product quality before and after the transfer must be consistent. If quality comparability cannot be proved, non-clinical and/or clinical bridging studies must be conducted.
- Simplification of application materials: In modules one to five, some materials can be simplified or exempted from submission according to the consistency before and after the transfer.
- Module One: It is necessary to provide:
- a description of the previous applications for domestic and overseas marketed drugs
- approval/disapproval certification documents
- documents of the transferor’s consent to transfer
- a statement of the relationship between the holder and the manufacturer
- quality standards of the transferred products.
- Module Two: Simplify the transfer materials in comparison with those of the pre-transfer approvals including the pharmaceutical quality review, non-clinical research data, clinical research data, etc.
- Module Three: Provide research data on raw materials, prescription process, quality research, stability and packaging materials in direct contact with drugs for production. Also simplify or provide exemptions from submission accordingly.
- Module Four: Provide the preparation safety test data of the product pre- and post-transfer and conduct a comparative analysis.
- Module Five: Clinical trials, in general, will not be required if proof can be provided that the quality of the products pre- and post-transfer is comparable and non-clinical research meets the requirements.
- Special circumstances: Further simplification is possible for transfers within the same parent company under a unified quality management system.
III. Additional Notes:
- Conditional Approval: Drugs with conditional approval for all indications are not allowed to be transferred to domestic production.
- Holder Transfer Restrictions: Drugs cannot be transferred multiple times to different domestic holders. Different specifications of the same drug must be transferred to the same domestic applicant.
- Verification and Inspection: Registration verification and inspection will be based on risk, according to the “Working Procedures for the Initiation of Drug Registration Verification and Inspection (Trial).”
- GMP Compliance: Drug holders and domestic manufacturers must undergo drug GMP compliance inspections
Further information
Read the original announcement on Drug registration in China for transferring the production of biological therapeutic products marketed abroad to in China manufacturing.
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