{"id":11122,"date":"2024-11-21T00:00:00","date_gmt":"2024-11-20T23:00:00","guid":{"rendered":"https:\/\/www.cabinet-magar.fr\/actualites\/essais-cliniques-fin-de-la-periode-transitoire\/"},"modified":"2024-11-21T00:00:00","modified_gmt":"2024-11-20T23:00:00","slug":"essais-cliniques-fin-de-la-periode-transitoire","status":"publish","type":"post","link":"https:\/\/www.cabinet-magar.fr\/de\/actualites\/essais-cliniques-fin-de-la-periode-transitoire\/","title":{"rendered":"Essais cliniques\u202f: fin de la p\u00e9riode transitoire"},"content":{"rendered":"<p>Lors du d\u00e9veloppement d\u2019un m\u00e9dicament ou d\u2019une nouvelle m\u00e9thode de soins, diff\u00e9rentes phases se succ\u00e8dent. Proches de la fin de la phase du d\u00e9veloppement, on retrouve les essais cliniques, c\u2019est-\u00e0-dire les essais sur les humains. Depuis 2022, les r\u00e8gles d\u2019autorisations de ces essais ont \u00e9t\u00e9 modifi\u00e9es par l\u2019Union europ\u00e9enne et il est temps de s\u2019y conformer\u2026<\/p>\n<h2>Essais cliniques\u202f: la transition entre les r\u00e9gimes d\u2019autorisation ne peut plus attendre<\/h2>\n<p>Les essais cliniques, qui font partie des derni\u00e8res \u00e9tapes du d\u00e9veloppement des produits m\u00e9dicaux, permettent d\u2019effectuer des tests sur les \u00eatres humains.<\/p>\n<p>De ce fait, leur contr\u00f4le et leur suivi sont n\u00e9cessairement tr\u00e8s r\u00e9glement\u00e9s.<\/p>\n<p>Le 28 f\u00e9vrier 2022, le r\u00e8glement europ\u00e9en relatif aux essais cliniques de m\u00e9dicaments est entr\u00e9 en vigueur, qui est venu poser un nouveau cadre pour les autorisations d\u2019essais cliniques qui doivent \u00eatre obtenues par les laboratoires d\u00e9veloppant de nouveaux produits.<\/p>\n<p>Cependant, une p\u00e9riode de 3 ans avait \u00e9t\u00e9 fix\u00e9e durant laquelle il \u00e9tait toujours possible de poursuivre des essais cliniques en vertu de l\u2019ancien r\u00e9gime d\u2019autorisation de la directive 2001\/20\/CE.<\/p>\n<p>L\u2019Agence nationale de s\u00e9curit\u00e9 du m\u00e9dicament et des produits de sant\u00e9 rappelle donc que cette p\u00e9riode transitoire arrive \u00e0 son terme.<\/p>\n<p>Ainsi, lorsque ce n\u2019est pas d\u00e9j\u00e0 fait, il est primordial pour les professionnels de formuler une demande d\u2019autorisation de transition dans le syst\u00e8me d\u2019information sur les essais cliniques (CTIS).<\/p>\n<p>L\u2019ANSM indique que les professionnels concern\u00e9s ont jusqu\u2019au 16 d\u00e9cembre 2024 pour entamer leurs d\u00e9marches afin de rentrer dans les d\u00e9lais.<\/p>\n<p>Au-del\u00e0, les professionnels pourraient se voir emp\u00eacher de poursuivre leurs essais.<\/p>\n<div>Sources :  <\/p>\n<ul>\n<li><a href=\"https:\/\/ansm.sante.fr\/actualites\/reglement-europeen-relatif-aux-essais-cliniques-de-medicaments-fin-de-la-periode-de-transition\" rel=\"noopener\" target=\"_blank\">Actualit\u00e9 de l\u2019ANSM du 15 novembre 2024\u202f: \u00ab\u202fR\u00e8glement europ\u00e9en relatif aux essais cliniques de m\u00e9dicaments\u202f: fin de la p\u00e9riode de transition\u202f\u00bb<\/a><\/li>\n<\/ul>\n<\/div>\n<p><a href=\"https:\/\/www.weblex.fr\/weblex-actualite\/essais-cliniques-fin-de-la-periode-transitoire\" target=\"_blank\" rel=\"noopener\">Essais cliniques : fin de la p\u00e9riode transitoire <\/a> &#8211; \u00a9 Copyright WebLex<\/p>\n<p><img decoding=\"async\" src=\"https:\/\/www.weblex.fr\/sites\/default\/files\/actualites\/images\/Shutterstock_essaiscliniquestransitionfin.jpg\"><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Lors du d\u00e9veloppement d\u2019un m\u00e9dicament ou d\u2019une nouvelle m\u00e9thode de soins, diff\u00e9rentes phases se succ\u00e8dent. Proches de la fin de la phase du d\u00e9veloppement, on retrouve les essais cliniques, c\u2019est-\u00e0-dire les essais sur les humains. Depuis 2022, les r\u00e8gles d\u2019autorisations de ces essais ont \u00e9t\u00e9 modifi\u00e9es par l\u2019Union europ\u00e9enne et il est temps de s\u2019y conformer\u2026<\/p>\n","protected":false},"author":0,"featured_media":11123,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[9,7],"tags":[],"class_list":["post-11122","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-actu-juridique","category-actualites"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.2 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Essais cliniques\u202f: fin de la p\u00e9riode transitoire - Cabinet Magar<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.cabinet-magar.fr\/actualites\/essais-cliniques-fin-de-la-periode-transitoire\/\" \/>\n<meta property=\"og:locale\" content=\"de_DE\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Essais cliniques\u202f: fin de la p\u00e9riode transitoire - Cabinet Magar\" \/>\n<meta property=\"og:description\" content=\"Lors du d\u00e9veloppement d\u2019un m\u00e9dicament ou d\u2019une nouvelle m\u00e9thode de soins, diff\u00e9rentes phases se succ\u00e8dent. 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