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The Authorization for Launching a Drug on the Market: An Administrative Decision in Both Medical and Economic Terms

Par : Type de matériel : TexteTexteLangue : français Détails de publication : 2001. Ressources en ligne : Abrégé : Apparently any authorisation to launch a drug on the market is a specific intervention by the public powers in the history of a drug which, at some given date, makes a division between an authority which is assumed by the public powers, and the life of the molecule on the market. In fact, the articulation between the market and the concerns of the public powers is not limited to such dual roles. On the contrary, at any moment in the “AMM” (“Authorisation to launch”) process, and at various levels, there is a constant articulation between medical concerns and business problems, both marketing and industrial strategies. The article shows up the intricate links between the medical and business sectors in the three components of the French “AMM” system: the “AMM” commission itself, the criteria and references for any evaluation, and the role of the “AMM” in the chain of public decisions relative to drug releases in general.
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Apparently any authorisation to launch a drug on the market is a specific intervention by the public powers in the history of a drug which, at some given date, makes a division between an authority which is assumed by the public powers, and the life of the molecule on the market. In fact, the articulation between the market and the concerns of the public powers is not limited to such dual roles. On the contrary, at any moment in the “AMM” (“Authorisation to launch”) process, and at various levels, there is a constant articulation between medical concerns and business problems, both marketing and industrial strategies. The article shows up the intricate links between the medical and business sectors in the three components of the French “AMM” system: the “AMM” commission itself, the criteria and references for any evaluation, and the role of the “AMM” in the chain of public decisions relative to drug releases in general.

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