Lors du d\u00e9veloppement d\u2019un m\u00e9dicament, diff\u00e9rentes phases se succ\u00e8dent. Proche de la fin du d\u00e9veloppement, se trouvent les essais cliniques, c\u2019est-\u00e0-dire les essais sur les humains. Ils font l\u2019objet d\u2019un encadrement tr\u00e8s important au niveau europ\u00e9en\u2026<\/p>\n
\n
Autorisation d\u2019essais cliniques : harmonisation europ\u00e9enne de la proc\u00e9dure<\/h2>\n
Les essais cliniques repr\u00e9sentent l\u2019une des derni\u00e8res \u00e9tapes du d\u00e9veloppement d\u2019un m\u00e9dicament. Cela marque le d\u00e9but des tests sur les humains apr\u00e8s les essais en laboratoires et ceux sur les animaux. Ils visent \u00e0 tester la tol\u00e9rance des patients et l\u2019efficacit\u00e9 du produit.<\/p>\n
Pour proc\u00e9der \u00e0 ces essais, les laboratoires doivent au pr\u00e9alable obtenir une autorisation de l\u2019Agence europ\u00e9enne des m\u00e9dicaments (European M\u00e9dicines Agency, EMA).<\/p>\n
\u00c0 compter du 31 janvier 2023, la proc\u00e9dure pour obtenir ces autorisations \u00e9volue.<\/p>\n
Les 30 \u00c9tats de l\u2019Espace \u00e9conomique europ\u00e9en (EEE), c\u2019est-\u00e0-dire les 27 \u00c9tats membres de l\u2019Union europ\u00e9enne auxquels s\u2019ajoutent l\u2019Islande, le Liechtenstein et la Norv\u00e8ge, devront n\u00e9cessairement passer par le Clinical Trials Information System (CTIS), une plateforme sur laquelle les laboratoires peuvent pr\u00e9senter leurs demandes et communiquer avec l\u2019EMA sur l\u2019avanc\u00e9e du projet.<\/p>\n
Lorsqu\u2019une autorisation d\u2019essais cliniques a \u00e9t\u00e9 attribu\u00e9e avant le 31 janvier 2023, les d\u00e9marches en lien avec l\u2019essai en cours pourront toujours \u00eatre faites selon les anciennes modalit\u00e9s. Notez qu\u2019\u00e0 compter du 31 janvier 2025, toutes les d\u00e9marches, ind\u00e9pendamment de la date d\u2019autorisation, devront \u00eatre faites par le biais du CTIS.<\/p>\n
Pour finir, retenez que le grand public pourra \u00e9galement utiliser le CTIS, par l\u2019interm\u00e9diaire d\u2019un espace d\u00e9di\u00e9, afin de s\u2019informer sur les essais cliniques en cours.<\/p>\n
Source<\/span> : Actualit\u00e9 de l\u2019ANSM du 19 janvier 2023 : \u00ab Essais cliniques m\u00e9dicaments : le portail CTIS devient l\u2019unique point d\u2019entr\u00e9e pour les nouvelles demandes au 31 janvier 2023 \u00bb<\/p>\nEssais cliniques : une plateforme unique en Europe<\/a> \u00a9 Copyright WebLex – 2023<\/p>\n<\/div>\n
<\/p>\n","protected":false},"excerpt":{"rendered":"
Lors du d\u00e9veloppement d\u2019un m\u00e9dicament, diff\u00e9rentes phases se succ\u00e8dent. Proche de la fin du d\u00e9veloppement, se trouvent les essais cliniques, c\u2019est-\u00e0-dire les essais sur les humains. Ils font l\u2019objet d\u2019un encadrement tr\u00e8s important au niveau europ\u00e9en\u2026<\/p>\n","protected":false},"author":0,"featured_media":4990,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[9,7],"tags":[],"class_list":["post-7390","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-actu-juridique","category-actualites"],"acf":[],"yoast_head":"\n
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