Singapore | HSA Updates Post-Marketing Vigilance Requirements for Therapeutic Products and CTGTPs — Expanding Lifecycle Pharmacovigilance and Safety Reporting Expectations GallerySingapore | HSA Updates Post-Marketing Vigilance Requirements for Therapeutic Products and CTGTPs — Expanding Lifecycle Pharmacovigilance and Safety Reporting Expectations
Singapore | HSA Updates Post-Marketing Vigilance Requirements for Therapeutic Products and CTGTPs — Expanding Lifecycle Pharmacovigilance and Safety Reporting Expectations
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Canada | Health Canada Expands Lifecycle Oversight of Medical Devices Through New Guidance Framework
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Brazil | Major Reform of National Research Ethics Oversight Advances Through New INAEP Governance Framework and Regulatory Actions
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UK | HRA Overhauls Non-CTIMP Requirements — Implementation from 28 April 2026
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Saudi Arabia | SFDA Publishes Framework on the Use of Real-World Data and Real-World Evidence for Regulatory Decision-Making GallerySaudi Arabia | SFDA Publishes Framework on the Use of Real-World Data and Real-World Evidence for Regulatory Decision-Making
2026, April 2026, Members-Only, RWD to Support Reg Decisions, Saudi Arabia, Secondary Use of Existing Data, Significant Update
Saudi Arabia | SFDA Publishes Framework on the Use of Real-World Data and Real-World Evidence for Regulatory Decision-Making
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EU | EDPB Publishes Draft Guidelines on Processing Personal Data for Scientific Research — Clarifying GDPR Expectations for Research and Real-World Evidence GalleryEU | EDPB Publishes Draft Guidelines on Processing Personal Data for Scientific Research — Clarifying GDPR Expectations for Research and Real-World Evidence
EU | EDPB Publishes Draft Guidelines on Processing Personal Data for Scientific Research — Clarifying GDPR Expectations for Research and Real-World Evidence
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USA | FDA Highlights Expanding Role of Real-World Evidence in Medical Device Decision-Making GalleryUSA | FDA Highlights Expanding Role of Real-World Evidence in Medical Device Decision-Making
2026, March 2026, Medical Devices, Members-Only, Minor Update, RWD to Support Reg Decisions, Secondary Use of Existing Data
USA | FDA Highlights Expanding Role of Real-World Evidence in Medical Device Decision-Making
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USA | FDA Final Guidance Expands Use of Patient Preference Information Across Product Lifecycle
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USA | Reagan-Udall Report Calls for Greater Regulatory Agility and New Evidence Approaches in Rare Disease Development
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