TFDA Regulatory Announcement

Announcement of ICH E17: Planning and Design of Multi-Regional Clinical Trials 2021-10-21 Announcement of Points of Attention in Using Real-world Data/Real-world Evidence as Technical Documents in Drug Registration Review 2021-07-02 Announcement of Amendment to Guidance for Pediatric Pharmacokinetic Studies 2021-03-23 Announcement of Real-world Evidence－Considerations in Evaluating the Relevance and Reliability 2021-03-17 Updated Announcement of The List of Adopted ICH Guidelines 2021-02-09 Announcement of Study Design of Real-world Evidence－Points to Consider in Pragmatic Clinical Trials 2021-01-20 Announcement of Clinical Safety Data Management: Definitions and Standards for Expedited Reporting 2021-01-13 Announcement of The Key Points of Pediatric and Rare Severe Disease Priority Review Voucher Program 2019-11-18 Amendment of The Review Mechanism of Abbreviated Review 2019-11-18 Amendment of The Review Mechanism of Priority Review 2019-11-18 Amendment of The Review Mechanism of Accelerated Approval 2019-11-18 Amendment of The Key Points of Breakthrough Therapy Designation 2019-11-18