Its contribution is to provide scientific opinions on the efficacy, quality and safety of medicines being authorised for marketing in Europe.
ACTIVITIES
Activities in the service of the EMA and of the WHO are:
- Participation in European committees and working groups on medicines,
- Participation in the expert groups making scientific evaluations of requests for marketing authorisation (AMM) at the European level,
- Participation in the expert groups re-evaluating the risk-benefit ratio for medicines already on the market,
- Participation in European pharmacovigilance efforts,
- Participation in scientific opinions during the development of medicines when requested by the pharmaceutical industry,
- Production of reports from expert committees as rapporteur or co-rapporteur,
- Development of analytical methods to guarantee pharmaceutical and chemical quality, particularly of generic medicines,
- Studies into the safety of medicines,
- Studies into the pharmaceutical quality of medicines,
- Development of monographs for the International Pharmacopeia of the WHO,
- Collaboration and skills sharing with the other European agencies.