The CDE (NMPA) has released draft guidelines to help drug developers and Regulatory authorities address common issues during drug development and clinical trial applications. The guidance aims to improve communication, streamline submissions, and support Regulatory decision-making.
Key Highlights:
- Public comments open until 18-Dec-2025
- Draft prepared by the Chemical Drug Clinical Department II, with multiple internal discussions and expert consultations
- Guidelines include an overview, FAQs, and technical requirements covering:
- Common clinical trial problems at various stages
- Selective safety data collection when safety profiles are established
- Clinical trial phases and data submission, including long-term safety/efficacy and staged submissions for accelerated review
- Consideration of racial factors per ICH E5(R1) for foreign clinical data
- Selection of primary and secondary efficacy indicators for confirmatory trials
- Phase II trials guidance on safety, dose-exposure-effect, and population targeting
- Development of improved new drugs addressing unmet clinical needs
- Feedback form attached to capture unit name, contact, proposed revisions, page/line numbers, and justification
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