EMA / MHRA
European Medicines Agency / UK Medicines and Healthcare Regulatory Agency — the EU and UK equivalents of the FDA.
The European Medicines Agency (EMA) is the EU regulatory body for human and veterinary medicines, headquartered in Amsterdam. The Medicines and Healthcare products Regulatory Agency (MHRA) is the UK equivalent, operating independently since Brexit. Both run their own review and approval processes — a drug approved by the FDA isn't automatically EMA- or MHRA-approved (and vice versa). For UK consumers, MHRA-approved status is the relevant authorisation. Some drugs are approved earlier or later in different jurisdictions (e.g. semaglutide was approved in the US before the EU).
- GlossaryPhase 3
The penultimate stage of clinical drug development — large randomised trials testing efficacy and safety against existing standards of care.
- GlossaryPharmacokinetics
How the body absorbs, distributes, metabolises, and eliminates a compound — "what the body does to the drug."
- GlossaryPharmacodynamics
"What the drug does to the body" — the relationship between concentration and effect.