The Taiwan FDA (TFDA) issued the draft guideline ICH E19: A Selective Approach to Safety Data Collection in Special Late-Stage Pre-Approval or Post-Approval Clinical Trials (Approval No. 1141419027), inviting comments for 60 days.
Aligned with the ICH framework, the draft defines when sponsors may limit certain safety data collection without compromising subject protection or study integrity.
Key highlights:
- Introduces Selective Safety Data Collection for trials with established safety profiles.
- Applies to late-stage or post-approval studies (e.g., new indications of approved drugs).
- Requires regulatory consultation before adoption and clear documentation in trial protocols.
- Excludes gene therapy and rare disease studies requiring full safety data capture.
- Aims to reduce trial burden while maintaining patient safety and data quality.
This draft reinforces TFDA’s commitment to harmonize with global ICH clinical and safety practices, ensuring efficient, risk-based data collection.
Select Mandate HA
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