Its contribution is to provide scientific opinions on the efficacy, quality and safety of medicines being authorised for marketing in Europe.
European Medicines Agency
The European Medicines Agency – Luxembourg National Focal Point provides expert scientific recommendations on the efficacy, quality, and safety, and risk-benefit ratio of medicines prior to and following marketing authorization in Europe.
Through its EMA focal point, CRP-Santé provides support to the Health Ministry of Luxembourg and the Medicines Control Service of the National Health Laboratory, as well as providing recommendations to the World Health Organization.
Further EMA – Luxembourg Focal Point activities include:
- Participation in European pharmacovigilance efforts
- Offering expert opinions to the pharmaceutical industry during drug development
- Development of analytical methods to guarantee quality of medicines, particularly generics
- Studies to gauge the safety and pharmaceutical quality of medicines
- Development of monographs for the WHO International Pharmacopeia
- Collaboration and skills sharing with the other European agencies.
Through its EMA focal point, the Public Research Centre for Health (CRP), has been providing support since 1995 to the Luxemburgish government and especially to the Pharmaceutical and Drugs Division (DPM) of the Health Ministry which fulfils the role of a Luxemburgish Drugs Agency, as well as to the Medicines Control Service of the National Health Laboratory, by providing experts able to participate in the activities of the European Medicines Agency.
At the same time, the EMA Focal Point also carries out evaluations for the WHO.