[Drugs under temporary use authorisation: 50 years of French drug development]

Abstract

Drug under temporary use authorisation (authorisation temporaire d' utilisation - ATU) was created in 1994 in France. Before this date, various procedures controlled patients' use of imported drug and drug in process. The AIDS pandemy development in 80's and the need to control news drugs patients' use contributed to the ATU statement setting up. This regulatory statement allows companies to sell drugs without market drug authorisation (autorisation de mise sur le marché - AMM), the letter being done in adequation with good pharmaceutical quality and a satisfactory level of benefices/ risks ratio. It's a recent French drug evaluation evolution.