Aspects juridiques comparés de la mise sur le marché des médicaments en France et aux Etats-Unis
Institution:
Paris 11Disciplines:
Directors:
Abstract EN:
In france and in the united states, the marketing of medicinal products requires a prior approval given on the basis of a file demonstrating the quality, safety and efficacy of the products. If the content and the format of the applications are quasi similar on both sides of the atlantic, the procedures of evaluation are different as are the environmental aspects of drug. In france, procedures are flexible as the system makes use of many external rapporteurs. In the united states, the system is heavier and involves much red tape. All the administrative stages concerning drugs are very controlled (investigational new drug, new drug application). In both countries, registration includes the considerations of administrative protection against generic products and is beginning to include those of health costs as well. The national evolutions are similar. Increasingly, the administrations must deal with new scientific and socio-economic contingencies. For france, a supplementary factor must be taken into due consideration: this is european integration.
Abstract FR:
La mise sur le marche des medicaments en france et aux etats-unis necessite une autorisation prealable octroyee sur la base d'un dossier demontrant la qualite, la securite et l'efficacite des produits. Si la composition et la presentation des dossiers de demande d'enregistrement sont analogues, il en va differemment des procedures d'evaluation et de l'environnement du medicament. En france, les procedures sont souples; le systeme fonctionne grace a de nombreux rapporteurs externes. Aux etats-unis, le systeme est plus lourd et procedurier. Toutes les etapes administratives du medicament sont tres controlees (investigational new drug, new drug application). Dans les deux pays, l'enregistrement prend en compte des considerations de protection administrative contre les medicaments generiques et commence a prendre en consideration les couts de sante de maniere indirecte. Les demarches nationales sont analogues. De plus en plus, les administrations nationales devront faire face a de nouvelles contingences scientifiques et socio-economiques. Pour la france, un facteur supplementaire est a prendre en consideration: l'integration europeenne.