The ANSM is setting up a one-stop-shop to simplify the procedures for requesting patients requiring treatment under temporary authorizations for registered use (ATUn).
From September, a one-stop-shop will be made available to healthcare professionals in order to simplify the procedures for requesting patients requiring treatment under temporary authorizations for registered use (ATUn). “This new system aims to guarantee access transparent, rapid and fair to therapeutic innovation for patients “, states theANSM.
Each year, ATUn allows nearly 20,000 patients suffering from serious or rare diseases to have access to drugs that do not have a marketing authorization (AMM) in France. “As part of its modernization and transparency program, the ANSM is transforming from September its system for processing requests for Temporary Authorizations for Registered Use (ATUn) in order to simplify it and strengthen rapid and fair access. to therapeutic innovation for patients, “the agency further indicates.
Treatment cannot be postponed
ATUn are issued by the ANSM, for patients who cannot be included in a clinical trial or for drugs that do not have a marketing authorization, but which can be presumed to provide clinical benefit. to these patients. They allow patients suffering from rare or serious diseases to access treatment when there is no suitable alternative available on the market, and the treatment cannot be postponed.
ANSM will also publish on his website the criteria allowing the rapid granting of these ATUn. These criteria are derived from clinical situations commonly encountered by practitioners. At the end of the year, an e-Saturne web application will be made available to healthcare professionals to allow remote transmission of ATUn requests (replacing the fax system) and thus further simplify exchanges.
3 million French
Rare diseases are generally serious, chronic, progressive, and the prognosis of life is often at stake. A disease is said to be rare when it affects less than one person in 2,000, ie for France less than 30,000 people for a given disease . Thus, more than 3 million French people are affected by one of the 7,000 rare diseases known to date and around 25 million people in Europe.
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