Lexique

Defining Health Authorization

Defining Health Authorization

The requirement of authorization (AMM in French) is central to health products, even for drugs (Agence Nationale de Sécurité du Médicament et des Produits de Santé, 2013 – National Security Agency of Medicines and Health Products, 2013). It is the result of a long process of validation. The process begins with exploratory studies in collaboration with clinicians. This research is based on Evidence Based Medicine invite a few test subjects intervention (studies some cases) and to see the truth of the action mechanisms previously isolated in basic research. The second step usually takes place in a laboratory certified research and aims to test the efficacy, safety, satisfaction, impact on quality of life and usefulness of the intervention. The third step is to assign a degree of efficiency and recommendation via one (or more) company (s) learned (s) for a given population. This step is based in particular on meta-analyzes. The fourth step is to enter the health authorities so that they advise on the procedure. The fifth step is to ensure that Parliament is informed to enable them to make decisions to take economic burden, health and / or social about innovative interventions. The sixth relates directly unions may reimburse all or part of the intervention. The latter rightly want to have key comparison innovations for knowingly choose. The seventh step allows healthcare professionals to use innovation in the regulatory framework and secure while being encouraged to strictly follow a set of specifications.

As part of health product, it is requested to the manufacturer to affix the CE mark following a procedure for assessing conformity with the essential requirements set out in European Directives. These European provisions were transposed into French law in the Code of Health (French National Security Agency of Medicines and Health Products, 2013).


Reference

Agence Nationale de Sécurité du Médicament et des Produits de Santé (2013). Website (in French).


To reference this Blog en Sante © article.

Ninot G (2014). Definition of authorization of health market. Blog en Sante, L17.

© Copyright 2014 Grégory Ninot. All rights reserved.