Bouzy Claire, Abadie Eric
Rev Prat. 2002 Mar 1;52(5):510-4.
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.
自1995年以来，欧洲实施了一种新的药品授权制度。该制度基于不同行为主体之间的合作，这些行为主体包括成员国的主管当局、欧洲药品评估局和欧盟委员会。这些合作伙伴以不同方式参与两种欧洲程序（集中程序和相互认可程序）中的一种，以便对新药品的疗效、安全性和质量进行评估。对这两种程序的描述（范围、时间框架、决策特点、不同利益相关者的作用、优势或困难……）有助于预见在下次立法修订中应改进的要点。
