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.
Shares Expanded access (compassionate use), Haute Autorité de Santé, EU HTA Regulation (EU) 2021/2282: joint clinical assessments, Regulation (EC) No 726/2004: the EU centralised procedure.
Shares Bundesinstitut für Arzneimittel und Medizinprodukte, Regulation (EC) No 141/2000: EU orphan medicines, EU HTA Regulation (EU) 2021/2282: joint clinical assessments, Gemeinsamer Bundesausschuss / IQWiG.
Shares Clinical Trials Regulation (EU) No 536/2014 and CTIS, Regulation (EC) No 726/2004: the EU centralised procedure, Medicines and Healthcare products Regulatory Agency, Regulatory divergence between regions.
Shares Swissmedic, Medicines and Healthcare products Regulatory Agency, FDA Oncology Center of Excellence, Regulatory divergence between regions.
Shares Swissmedic, Medicines and Healthcare products Regulatory Agency, FDA Oncology Center of Excellence, Regulatory divergence between regions.
Shares Regulation (EC) No 141/2000: EU orphan medicines, RACE for Children Act, Accelerated approval, Paediatric oncology roadmap: cooperative-group cures → engineered immunity → drugs developed for children first.
Shares ICH good clinical practice (E6), Regulation (EC) No 726/2004: the EU centralised procedure, Trial modernisation roadmap: the randomised trial → platforms and adaptive designs → decentralised, pragmatic and always-on, Global access and affordability roadmap: essential medicines and generics → biosimilars and frugal trials → reliance, pooling and homegrown innovation.
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.
Commercial and regulated products that this organisation sells. Each card says what is behind it: a regulator's database, the literature, a public body's list, or only the company's own words. Listing is not endorsement, and a clearance is a regulatory fact, not a clinical one.
The European Union's single system for applying to run a trial and for publishing it, which replaced the old national applications and the EudraCT register.