USA | FDA Finalises Post-Approval Pregnancy Safety Studies Guidance — Strengthening Expectations for Pregnancy Registries, Complementary RWD Studies and Global Pregnancy Safety Evidence Generation GalleryUSA | FDA Finalises Post-Approval Pregnancy Safety Studies Guidance — Strengthening Expectations for Pregnancy Registries, Complementary RWD Studies and Global Pregnancy Safety Evidence Generation
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- UK | MHRA Consults on Draft Rare Disease Therapies Regulatory Framework — Proposed Investigational Marketing Authorisation Would Embed RWE Into Lifecycle Access Model Gallery
UK | MHRA Consults on Draft Rare Disease Therapies Regulatory Framework — Proposed Investigational Marketing Authorisation Would Embed RWE Into Lifecycle Access Model
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- EU | EMA Adds New RWD Q&A — Reinforcing ICH M14 Expectations for Non-Interventional Studies Using Real-World Data Gallery
EU | EMA Adds New RWD Q&A — Reinforcing ICH M14 Expectations for Non-Interventional Studies Using Real-World Data
2026, EMA, EU, May 2026, Members-Only, Moderate Update, RWD to Support Reg Decisions, Secondary Use of Existing Data -
- CHINA | NEW BIOMEDICAL TECHNOLOGIES REGULATION TAKES EFFECT — CREATING A NATIONAL FRAMEWORK FOR CLINICAL RESEARCH, TRANSLATIONAL APPLICATION AND LONG-TERM SAFETY OVERSIGHT Gallery
CHINA | NEW BIOMEDICAL TECHNOLOGIES REGULATION TAKES EFFECT — CREATING A NATIONAL FRAMEWORK FOR CLINICAL RESEARCH, TRANSLATIONAL APPLICATION AND LONG-TERM SAFETY OVERSIGHT
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