European Medicines Agency

E3950

The European Medicines Agency is the European Union’s regulatory authority responsible for the scientific evaluation, supervision, and safety monitoring of medicines for human and veterinary use.

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Statements (51)

Predicate Object
instanceOf European Union agency
medicines regulatory authority
abbreviation EMA
appliesTo human medicines
veterinary medicines
cooperatesWith EU member state national medicines agencies
European Centre for Disease Prevention and Control
European Commission
Heads of Medicines Agencies
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use
World Health Organization
country European Union
formerHeadquartersCountry United Kingdom
formerHeadquartersLocation London, England
surface form: London
foundedBy European Union
hasCommittee Committee for Advanced Therapies
Committee for Herbal Medicinal Products
Committee for Proprietary Medicinal Products
surface form: Committee for Medicinal Products for Human Use

Committee for Medicinal Products for Veterinary Use
Committee for Orphan Medicinal Products
Paediatric Committee
European Medicines Agency self-linksurface differs
surface form: Pharmacovigilance Risk Assessment Committee
headquartersCountry Netherlands
headquartersLocation Amsterdam
inception 1995
jurisdiction European Union
language English
legalBasis Regulation (EC) No 726/2004
mission to protect human and animal health in the EU by ensuring that medicines are safe, effective and of high quality
parentOrganization European Union
predecessor Committee for Proprietary Medicinal Products
relocatedDueTo Brexit
role coordination of COVID-19 vaccine evaluations
coordination of EU medicines regulatory network
coordination of inspections related to medicines
crisis preparedness and management for medicines
evaluation of marketing authorisation applications
management of orphan medicinal product designation
management of paediatric investigation plans
management of safety signals for medicines
pharmacovigilance coordination
provision of scientific advice to medicine developers
publication of medicine assessment reports
publication of safety communications
safety monitoring of medicines
scientific evaluation of medicines
supervision of medicines
support for development of new medicines
support to EU member states on medicines regulation
transparency of medicines information
website https://www.ema.europa.eu

Referenced by (39)

Full triples — surface form annotated when it differs from this entity's canonical label.

EMA alsoKnownAs European Medicines Agency
subject surface form: European Medicines Agency
this entity surface form: European Medicines Evaluation Agency
Avastin approvedBy European Medicines Agency
Darzalex approvedBy European Medicines Agency
Fampyra approvedBy European Medicines Agency
Lucentis approvedBy European Medicines Agency
Perjeta approvedBy European Medicines Agency
Spinraza approvedBy European Medicines Agency
Xolair approvedBy European Medicines Agency
Heads of Medicines Agencies collaboratesWith European Medicines Agency
Regulation (EC) No 726/2004 definesPowersOf European Medicines Agency
Regulation (EC) No 726/2004 definesRoleOf European Medicines Agency
Plegridy hasApprovalAuthority European Medicines Agency
Tecfidera hasApprovalBy European Medicines Agency
European Medicines Agency hasCommittee European Medicines Agency self-linksurface differs
this entity surface form: Pharmacovigilance Risk Assessment Committee
this entity surface form: European Agency for the Evaluation of Medicinal Products
Amsterdam hostsInstitution European Medicines Agency
Remicade isApprovedBy European Medicines Agency
Stelara isApprovedBy European Medicines Agency
this entity surface form: European Medicines Agency headquarters
Committee for Advanced Therapies parentOrganization European Medicines Agency
Paediatric Committee parentOrganization European Medicines Agency
Committee for Advanced Therapies partOf European Medicines Agency
Committee for Herbal Medicinal Products partOf European Medicines Agency
Committee for Orphan Medicinal Products partOf European Medicines Agency
Paediatric Committee partOf European Medicines Agency
EMA predecessor European Medicines Agency
subject surface form: European Medicines Agency
this entity surface form: European Agency for the Evaluation of Medicinal Products
Certificates of Suitability (CEP) recognizedBy European Medicines Agency
subject surface form: Certificates of Suitability
Tecentriq regulatoryApproval European Medicines Agency
Fampyra riskManagementPlanRequiredBy European Medicines Agency