European Medicines Agency
The EU agency whose Committee for Medicinal Products for Human Use recommends the marketing authorisations for cancer drugs across all member states.
Overview
Founded in 1995 in London and relocated to Amsterdam in 2019, the EMA coordinates the scientific evaluation of medicines for the European Union through the centralised procedure, which is mandatory for cancer drugs and advanced therapies. The Committee for Medicinal Products for Human Use (CHMP) issues opinions that the European Commission converts into EU-wide authorisations, while the Committee for Advanced Therapies handles CAR-T and gene therapies and PRIME gives early support to promising medicines. The agency publishes European Public Assessment Reports and clinical data, runs conditional marketing authorisation for unmet need, and since 2025 works alongside the EU Health Technology Assessment Regulation's joint clinical assessments, which begin with oncology medicines. Trial registration runs through CTIS.
- Centralised procedure and CHMP opinions
- Committee for Advanced Therapies
- PRIME and conditional marketing authorisation
- Clinical data publication and CTIS