The role of AFSSAPS in granting market approval and providing guidelines.

Health authorities have the responsibility to ensure the efficacy and safety of the drugs to be launched on the market. Market approval is only granted after a thorough assessment of the product and examination of the file submitted by the drug company in question. During the registration process, in assessing the effect of antibiotic therapy, antimicrobial resistance must be taken into account in order to better define indications, dosage and dosing regimens. In France, the increased responsibility and influence regarding public health security and medical products of the AFSSAPS (Agence Francaise de Securite Sanitaire des Produits de Sante) has had a major effect on promoting the right use of drugs. The control of antibiotic resistance involves a more judicious antibiotic use and improved antibiotic therapy. Guidelines for the appropriate use of antibiotics have been established and are of practical value, but should be accompanied by complementary action (information, explanation, and epidemiological follow-up) as part of a global programme for preventing the spread of antimicrobial resistance. (C) 2000 Editions scientifiques et medicales Elsevier SAS.