[Sanitary risk: medicinal products and medical devices].
Health products at large and medicinal products in particular, relieve treat and restore through a pharmacological action on human body which might bear a part of risk. Therefore, medicinal products' effects are not considered once when the product comes to the market but permanently through its life. The benefit/risk ratio evolves from day to day according to the development of scientific knowledge and the feedback we have from the use of products in their real conditions of use. The ratio is assessed differently depending on the severity degree of the disease to be treated. The cursor, and then the risk level which can be acceptable and accepted, changes over time for the same kind of diseases along with therapeutic progress. The renewal and strengthening of post-marketing authorization surveillance is based on the early adoption of risk management programs for products with high security expectations.
Marimbert
Jean
J
Afssaps, 93285 Saint-Denis Cedex. Jean.marimbert@afssaps.sante.fr
D004345:Drug Industry / Q000592:standards; D006801:Humans; D004364:Pharmaceutical Preparations; D011358:Product Surveillance, Postmarketing; D012308:Risk Management
D004364:Pharmaceutical Preparations