Amélioration du processus décisionnel pour l'application du décret APSIÂ : l'expérience française

New requirements for the preparation and delivery of named patient products (NPPs) were introduced by the French authorities in February 2004. A working group composed of representatives of allergist and manufacturers, named “APSI”, was created. This group set up a decision-making process to establish a list of clinically relevant allergen extracts in line with these new requirements. This list was then submitted for validation to the French Drug Regulatory Agency (Agence française de sécurité sanitaire des produits de santé [Afssaps]). A list of 66 mother preparations was published by Afssaps in December 2007. This procedure guaranteed French allergists that the available allergen extracts are clinically relevant and that their quality is consistent with international recommendations, which benefits patients, the medical community and manufacturers. It is the first time in Europe that NPPs have been registered by governmental authorities. This action needs to go on.