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.
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
Pages like this
not linked directly; found by shared links- InstitutionTherapeutic Goods Administration
Shares Swissmedic, Medicines and Healthcare products Regulatory Agency, FDA Oncology Center of Excellence, Regulatory divergence between regions.
- InstitutionHealth Canada
Shares Swissmedic, Medicines and Healthcare products Regulatory Agency, FDA Oncology Center of Excellence, Regulatory divergence between regions.
- InstitutionAgência Nacional de Vigilância Sanitária
Shares Comisión Federal para la Protección contra Riesgos Sanitarios, FDA Oncology Center of Excellence, Regulatory divergence between regions, Most of the world has almost no cancer care.
- IdeaMutual recognition of ethics review across countries
Shares EU Clinical Trials Register / CTIS, EORTC, Regulatory divergence between regions.
- InstitutionISPOR – The Professional Society for Health Economics and Outcomes Research
Shares Haute Autorité de Santé, Gemeinsamer Bundesausschuss / IQWiG, National Institute for Health and Care Excellence.
- InstitutionClinical Data Interchange Standards Consortium
Shares Pharmaceuticals and Medical Devices Agency, FDA Oncology Center of Excellence, Regulatory divergence between regions.
- InstitutionScottish Medicines Consortium
Shares Medicines and Healthcare products Regulatory Agency, National Institute for Health and Care Excellence.
- IdeaReciprocal recognition of tumour-agnostic and rare-indication approvals across regulators
Shares Accelerated approval, Regulatory divergence between regions, Most of the world has almost no cancer care.