Tag: regulatory affairs
MHRA Safety Roundup: June 2026 — Key Drug and Device Alerts for Clinicians
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has published its June 2026 safety roundup, consolidating critical alerts for…
EMA Launches Email Notifications for Clinical Trial Information System
The European Medicines Agency has rolled out email notification subscriptions in CTIS, enabling clinical trial sponsors and researchers to receive…
South Africa’s Drug Regulator Sets Patient Safety as Core Mission After Five Years of Operations
Since its 2018 establishment, South Africa's Health Products Regulatory Authority has anchored patient safety as the cornerstone of its regulatory…
UK Medical Device Manufacturers Must Navigate New MHRA Registration System Post-Brexit
Medical device manufacturers must now register separately with the UK's MHRA for market access in Great Britain and Northern Ireland…
Danish Medicines Agency Launches Cell Therapy Clinical Trial Template
The Danish Medicines Agency has released a standardized Investigator's Brochure template for cell therapy clinical trials, designed to streamline regulatory…
UK’s MHRA Launches Innovation Guidance to Accelerate Medical Device and Drug Development
The UK's MHRA has published formal guidance for drug and medical device developers, offering free access to regulatory expertise to…
How statistical paradoxes mislead drug safety decisions—and why AI may help
Statistical reasoning errors in drug safety evaluation—including the prosecutor's fallacy and Simpson's paradox—systematically distort causality judgments and remain inadequately audited…
FDA’s Pazdur Calls for Agency Restructuring Amid China Competition and Internal Upheaval
FDA's Rick Pazdur calls for fundamental agency restructuring following internal disruption, citing China competition as key driver for reform. Speaking…