L’Europe des médicaments : modalités d’enregistrement et cas particulier des antibiotiques

Objectives. - Provide information regarding evolution from the past evaluation of drugs, mainly performed at a national level, to the current trend of evaluation of drugs increasingly becoming European evaluation. Procedures. - Three registration procedures are now available to market drugs in the European community: the centralised procedure, the mutual recognition procedure and the decentralised procedure. When all European parties are involved it might be challenging to obtain a consensual position (common denominator). In any case the opinion of the majority prevails over that of the minority. The tools. - Fortunately, they are several tools for facilitating the consensus (before the marketing approval: guidance for the clinical development of drugs in specific area, scientific advices; after the marketing approval: arbitration procedures, introduction of information in the marketing authorisation to alert health care professionals about the limits in the product development, etc). National level and official guidelines. - At a national level, official therapeutic guidelines are useful tools to ensure an appropriate use of antibiotics, taking into account national specificities (including epidemiological). These national guidelines are referred to in the corresponding section of the therapeutic indications in the antibiotics' Summary of Product Characteristics. Even if the European context in the evaluation may raise some difficulties, notably a potential toss of autonomy, this potential toss of autonomy is only relative. Conclusion. - Overall, the European context, through the enlarged debate it allows, is first and foremost a way to consolidate the benefit/risk assessment of drugs. (C) 2008 Elsevier Masson SAS. All rights reserved.