EMA - European Medicines Agency
The EMA is responsible for the scientific evaluation of applications for European Union (EU) marketing authorisations for human and veterinary medicines in the centralised procedure.
The Agency provides scientific opinions, but it is not responsible for issuing decisions on whether to grant, suspend or revoke a marketing authorisation for any medicine. For centrally authorised medicines, this type of legal decision is issued by the European Commission.
The EMA is responsible for coordinating the EU's safety-monitoring or 'pharmacovigilance' system for medicines. It constantly monitors the safety of medicines through the EU network and can take action if information indicates that the benefit-risk balance of a medicine has changed since it was authorised.
The EMA's committees are involved in referral procedures to resolve issues such as concerns over the safety or benefit-risk balance of a medicine or a class of medicines. In a referral, the EMA is requested to conduct a scientific assessment of a particular medicine or class of medicines on behalf of the EU. The matter is ‘referred’ to the EMA so that it can make a recommendation for a harmonised position across the EU.
The Agency is responsible for coordinating inspections requested by its committees in connection with the assessment of marketing-authorisation applications or referrals.
Committee for Medicinal Products for Human Use (CHMP)
Pharmacovigilance Risk Assessment Committee (PRAC)
Committee for Medicinal Products for Veterinary Use (CVMP)
Committee for Orphan Medicinal Products (COMP)
Committee on Herbal Medicinal Products (HMPC)
Committee for Advanced Therapies (CAT)
Paediatric Committee (PDCO)