Drug Approvals
What Is Drug Approval? How FDA and EMA Decide
How drug approval works: what regulators assess, how FDA and EMA review differ, expedited pathways, conditional approvals, and what happens after authorisation.
European Medicines Agency
The European Medicines Agency coordinates the scientific assessment of medicines for the European Union, drawing on assessors from national authorities rather than reviewing everything in-house. Its committees — CHMP for human medicines, PRAC for safety, and others for orphan, paediatric and advanced therapy products — produce an opinion; the European Commission takes the legally binding decision.
We cover the EMA because the split between scientific opinion and legal decision is frequently misdescribed, and because an EU-wide authorisation still leaves pricing and reimbursement to each member state. Approval and availability are different events.
Drug Regulation
EMA Explained: How Europe Regulates Medicines
What the European Medicines Agency does: the centralised procedure, CHMP and PRAC, marketing authorisation, pharmacovigilance, and how EMA differs from the FDA.
Drug Regulation
How New Medicines Are Approved: FDA and EMA Paths
FDA and EMA regulatory pathways compared: standard and expedited routes, evidence requirements, decision structures, and why approvals differ between regions.