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 GalleryUK | 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 GalleryEU | 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 GalleryCHINA | NEW BIOMEDICAL TECHNOLOGIES REGULATION TAKES EFFECT — CREATING A NATIONAL FRAMEWORK FOR CLINICAL RESEARCH, TRANSLATIONAL APPLICATION AND LONG-TERM SAFETY OVERSIGHT
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- BRAZIL | INAEP Issues New Operational Guidance to Implement Law No. 14,874/2024 — Strengthening CEP Governance, Review Timelines and SINEP Standardisation Gallery
BRAZIL | INAEP Issues New Operational Guidance to Implement Law No. 14,874/2024 — Strengthening CEP Governance, Review Timelines and SINEP Standardisation
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- Singapore | HSA Updates Post-Marketing Vigilance Requirements for Therapeutic Products and CTGTPs — Expanding Lifecycle Pharmacovigilance and Safety Reporting Expectations Gallery
Singapore | HSA Updates Post-Marketing Vigilance Requirements for Therapeutic Products and CTGTPs — Expanding Lifecycle Pharmacovigilance and Safety Reporting Expectations
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