# European Medicines Agency

Source: https://onco.cc/institutions/ema/  
OnCo record `ema` (Institution). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

The EU agency whose Committee for Medicinal Products for Human Use recommends the marketing authorisations for cancer drugs across all member states.

## Summary

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.

## Fields

- Kind: Institution
- Last checked: 2026-09-09
- Also known as: EMA; CHMP
- City: Amsterdam, NL
- Type: government
- Website: https://www.ema.europa.eu

## Sources

- EMA: https://www.ema.europa.eu
- CHMP: https://www.ema.europa.eu/en/committees/committee-medicinal-products-human-use-chmp

## Connected records

- collections: [EMA news and CHMP meeting highlights](https://onco.cc/collections/src-ema-chmp/), [EU Clinical Trials Register / CTIS](https://onco.cc/collections/eudract-ctis/)
- technologies: [CAR-T cell therapy](https://onco.cc/technologies/car-t/), [DPYD genotyping and DPD phenotyping before fluoropyrimidines](https://onco.cc/technologies/dpyd-genotyping/)
- companies: [EORTC](https://onco.cc/companies/curie-nki-eortc/)
- institutions: [ACCELERATE](https://onco.cc/institutions/accelerate-platform/), [Bundesinstitut für Arzneimittel und Medizinprodukte](https://onco.cc/institutions/bfarm/), [Comisión Federal para la Protección contra Riesgos Sanitarios](https://onco.cc/institutions/cofepris/), [European Hematology Association](https://onco.cc/institutions/eha/), [FDA Oncology Center of Excellence](https://onco.cc/institutions/fda-oce/), [Gemeinsamer Bundesausschuss / IQWiG](https://onco.cc/institutions/g-ba-iqwig/), [Haute Autorité de Santé](https://onco.cc/institutions/has-france/), [Medicines and Healthcare products Regulatory Agency](https://onco.cc/institutions/mhra/), [National Institute for Health and Care Excellence](https://onco.cc/institutions/nice/), [Paul-Ehrlich-Institut](https://onco.cc/institutions/paul-ehrlich-institut/), [Pharmaceuticals and Medical Devices Agency](https://onco.cc/institutions/pmda/), [Swissmedic](https://onco.cc/institutions/swissmedic/)
- terms: [Accelerated approval](https://onco.cc/terms/accelerated-approval/), [Clinical Trials Regulation (EU) No 536/2014 and CTIS](https://onco.cc/terms/eu-clinical-trials-regulation/), [EU HTA Regulation (EU) 2021/2282: joint clinical assessments](https://onco.cc/terms/eu-hta-regulation/), [EU pharmaceutical package reform (2023 proposal)](https://onco.cc/terms/eu-pharma-package/), [Expanded access (compassionate use)](https://onco.cc/terms/expanded-access/), [ICH good clinical practice (E6)](https://onco.cc/terms/ich-gcp/), [RACE for Children Act](https://onco.cc/terms/race-for-children-act/), [Regulation (EC) No 141/2000: EU orphan medicines](https://onco.cc/terms/eu-orphan-regulation/), [Regulation (EC) No 1901/2006: EU paediatric medicines](https://onco.cc/terms/eu-paediatric-regulation/), [Regulation (EC) No 726/2004: the EU centralised procedure](https://onco.cc/terms/eu-regulation-726-2004/)
- people: [Emer Cooke](https://onco.cc/people/emer-cooke/)
- bottlenecks: [Most of the world has almost no cancer care](https://onco.cc/bottlenecks/b-global-access/), [Regulatory divergence between regions](https://onco.cc/bottlenecks/b-regulatory-fragmentation/)
- ideas: [Drop the extra switching studies for interchangeable oncology biosimilars](https://onco.cc/ideas/idea-cost-interchangeable-oncology-biosimilars/)
- roadmaps: [Global access and affordability roadmap: essential medicines and generics → biosimilars and frugal trials → reliance, pooling and homegrown innovation](https://onco.cc/roadmaps/global-access-roadmap/), [Paediatric oncology roadmap: cooperative-group cures → engineered immunity → drugs developed for children first](https://onco.cc/roadmaps/paediatric-oncology-roadmap/), [Trial modernisation roadmap: the randomised trial → platforms and adaptive designs → decentralised, pragmatic and always-on](https://onco.cc/roadmaps/trial-modernisation-roadmap/)

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