[Drugs in Europe].
Since 1995, a new system for authorization of medicinal products has been implemented in Europe. It is based on the collaboration of different actors which are the competent authorities of the member States, the European Agency for the evaluation of medicinal products and the European Commission. These partners are differently involved in one or the other of the 2 European procedures (centralised and mutual recognition) in order to allow the assessment of efficacy, safety and quality of new medicinal products. Description of the 2 procedures (scope, time-frame, characteristics of the decision, role of different stakeholders, advantages or difficulties...) allows to foresee the points which should be improved in the next revision of the legislation.
Bouzy
Claire
C
claire.bouzy@afssaps.sante.fr
Abadie
Eric
E
D003657:Decision Making; D017277:Drug Approval / Q000331:legislation & jurisprudence*; D004341:Drug Evaluation / Q000331:legislation & jurisprudence*; D005060:Europe; D006291:Health Policy; D006801:Humans; D007391:International Cooperation