The FDA, the EMA and their counterparts decide what may be sold, on what evidence, and with what warnings. Their decisions are made on submitted data, under statutory deadlines, and increasingly under public scrutiny of both.
Our coverage explains how these agencies work, how their standards differ, and why the same product can be approved in one region and refused in another.
How healthcare regulation works: who regulates professionals, providers, medicines, devices and data, how rules are enforced, and why regulatory systems differ.
What the FDA does: regulating medicines, biologics, medical devices, food and tobacco, how review and inspection work, its centres, powers and known criticisms.
What the European Medicines Agency does: the centralised procedure, CHMP and PRAC, marketing authorisation, pharmacovigilance, and how EMA differs from the FDA.
How medical device regulation works: risk classification, FDA pathways, EU MDR and notified bodies, clinical evidence, software rules and post-market surveillance.