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.

All labels observed (7)

How this entity was disambiguated

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

How these facts were elicited

Referenced by (86)

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

European Union agencies hasExample European Medicines Agency
HMA collaboratesWith European Medicines Agency
HMA Multi-Annual Work Plan isAlignedWith European Medicines Agency
this entity surface form: European Medicines Agency network strategy
PDCO parentOrganization European Medicines Agency
Paediatric Regulation implementedBy European Medicines Agency
CAT partOf European Medicines Agency
subject surface form: Committee for Advanced Therapies
CAT parentOrganization European Medicines Agency
subject surface form: Committee for Advanced Therapies
ICH hasFoundingRegulator European Medicines Agency
ICH Q9 Quality Risk Management regionallyImplementedBy European Medicines Agency
ICH M4 Common Technical Document adoptedBy European Medicines Agency
Alimta hasApprovalAgency European Medicines Agency
Taltz isApprovedBy European Medicines Agency
Emgality approvalBy European Medicines Agency
onasemnogene abeparvovec approvedBy European Medicines Agency
risdiplam approvedBy European Medicines Agency
Tegsedi approvedBy European Medicines Agency
HMPC partOf European Medicines Agency
HMPC parentOrganization European Medicines Agency
Committee for Medicinal Products for Human Use partOf European Medicines Agency
VMD collaboratesWith European Medicines Agency
subject surface form: Veterinary Medicines Directorate
Xeloda hasApprovalAgency European Medicines Agency
faricimab approvedBy European Medicines Agency
andexanet alfa approvedBy European Medicines Agency
Epidiolex approvedBy European Medicines Agency
rimonabant wasApprovedBy European Medicines Agency
European Food Safety Authority cooperatesWith European Medicines Agency
Pfizer–BioNTech receivedEmergencyUseAuthorizationFrom European Medicines Agency
European medicines regulatory authorities cooperateWith European Medicines Agency
velpatasvir approvedBy European Medicines Agency
subject surface form: Velpatasvir
NewLink Genetics regulatoryInteraction European Medicines Agency