{"id":13915,"date":"2015-11-25T16:00:30","date_gmt":"2015-11-25T15:00:30","guid":{"rendered":"https:\/\/blogdelarechercheclinique.com\/?p=13915"},"modified":"2024-05-22T16:32:56","modified_gmt":"2024-05-22T14:32:56","slug":"points-importants-du-nouveau-reglement-europeen-2014","status":"publish","type":"post","link":"https:\/\/blogdelarechercheclinique.com\/en\/points-importants-du-nouveau-reglement-europeen-2014\/","title":{"rendered":"Les points importants du nouveau r\u00e8glement europ\u00e9en de 2014"},"content":{"rendered":"

Article r\u00e9dig\u00e9 par la Soci\u00e9t\u00e9 Pharmaspecific, sp\u00e9cialiste en recherche clinique<\/i><\/span><\/p>\n

Te souviens-tu que l\u2019ann\u00e9e derni\u00e8re, la Directive Europ\u00e9enne de 2001 (2001\/20\/CE) avait \u00e9t\u00e9 abrog\u00e9e par le r\u00e8glement europ\u00e9en de 2014<\/a>\u00a0? Ce nouveau r\u00e8glement, applicable aux essais cliniques de m\u00e9dicaments \u00e0 usage humain, entrera en application en 2016. Mais au fait, qu\u2019a-t-il de plus que la directive de 2001 exactement\u00a0?
\nDans cet article, nous te proposons un r\u00e9sum\u00e9 des points importants que pr\u00e9sente ce nouveau r\u00e8glement europ\u00e9en<\/strong><\/a>, afin que tu sois pr\u00eat(e) pour l\u2019ann\u00e9e prochaine\u00a0!<\/p>\n

1. Mais avant, quelques dates\u2026<\/h2>\n

Comme dit pr\u00e9c\u00e9demment, le nouveau r\u00e8glement europ\u00e9en a \u00e9t\u00e9 a adopt\u00e9 le 16 Avril 2014 par le Parlement Europ\u00e9en. Il a \u00e9t\u00e9 publi\u00e9 un mois plus tard (le 27 mai 2014) au Journal Officiel de l\u2019Union Europ\u00e9enne (UE) et entrera en application deux ans apr\u00e8s sa publication, soit en Mai 2016.
\nPour rappel, ce r\u00e8glement s\u2019applique uniquement aux essais cliniques portant sur des m\u00e9dicaments conduits dans l\u2019UE (et non aux essais cliniques non interventionnels\u00a0; essais portant sur des produits autres que les m\u00e9dicaments\u00a0: dispositifs m\u00e9dicaux, cosm\u00e9tiques ou\u00a0hors produits de sant\u00e9).<\/p>\n

2. Ses objectifs<\/h2>\n

L\u2019objectif principal de cette nouvelle r\u00e9glementation est de faciliter les essais ayant lieu dans plusieurs Etats Membres de l\u2019UE, afin de rendre la Recherche Biom\u00e9dicale<\/strong> plus attractive en Europe et pour restaurer sa comp\u00e9titivit\u00e9. Voici les points importants pr\u00e9vus dans cette nouvelle r\u00e9glementation :<\/p>\n

A. Une harmonisation<\/strong> du contenu de demande d\u2019autorisation pour tous les Etats Membres.<\/h3>\n

Pour simplifier les d\u00e9marches de tout essai clinique men\u00e9 dans au moins un Etat Membre de l\u2019UE, un dossier de demande d\u2019Autorisation d\u2019Essai Clinique sera d\u00e9pos\u00e9 par le promoteur, sur le portail informatique <\/u>unique<\/u> (g\u00e9r\u00e9 par l\u2019Agence Europ\u00e9enne du M\u00e9dicament\u00a0: EMA) et un Etat Membre Rapporteur sera d\u00e9sign\u00e9.
\nConcr\u00e8tement, le dossier unique comprendra 2 parties\u00a0: une partie scientifique sera revue conjointement par les Etats Membres concern\u00e9s, et pour la partie\u00a0\u00e9thique, elle sera revue par le comit\u00e9 d\u2019\u00e9thique national de chaque Etat Membre ; le tout coordonn\u00e9 par l\u2019Etat Membre Rapporteur, dont appartient la d\u00e9cision nationale d\u2019autorisation unique.
\nEn ce qui concerne les d\u00e9lais\u00a0de revue, tu trouveras ci-dessous un tableau r\u00e9capitulatif de l\u2019ANSM<\/a>.<\/p>\n

\"Demandes<\/p>\n

Ainsi gr\u00e2ce \u00e0 ce portail, la coop\u00e9ration entre les Etats Membres sera renforc\u00e9e, mais surtout, le gain de temps sera consid\u00e9rable puisque cela \u00e9vite au promoteur de devoir pr\u00e9senter \u00e0 plusieurs Etats Membres des informations en grande partie identiques sur l\u2019essai clinique<\/strong>\u00a0: fini les d\u00e9lais d\u2019attente\u00a0! Fini les formalit\u00e9s administratives trop longues\u00a0!<\/p>\n

Pour se pr\u00e9parer \u00e0 l\u2019application de ce nouveau r\u00e8glement, l\u2019ANSM a mis en place une phase pilote, dans laquelle participent des promoteurs et une dizaine de CPP. Tu trouveras plus d\u2019informations \u00e0 ce sujet ici<\/a>.<\/p>\n

B. Une transparence<\/strong> des essais cliniques<\/h3>\n

La transparence est l\u2019un des points majeurs de ce nouveau r\u00e8glement. En effet, l\u2019ensemble des informations relatives aux essais cliniques sera regroup\u00e9 dans une base de donn\u00e9es de l\u2019UE. Cependant, des exceptions concernant la publication de certaines donn\u00e9es, jug\u00e9es confidentielles sont \u00e0 noter : protection des donn\u00e9es \u00e0 caract\u00e8re personnel, protection d\u2019informations confidentielles \u00e0 caract\u00e8re commercial (pouvant nuire \u00e0 la comp\u00e9titivit\u00e9 du laboratoire)\u2026 Le masquage des informations se fera au cas par cas, sous r\u00e9serve de demandes explicites de la soci\u00e9t\u00e9.<\/p>\n

Plus pr\u00e9cis\u00e9ment, dans un d\u00e9lai d\u2019un an \u00e0 compter de la fin de l\u2019\u00e9tude dans tous les Etats-Membres concern\u00e9s, un r\u00e9sum\u00e9 des r\u00e9sultats devra \u00eatre accessible gratuitement au public via cette base, et ce, quels que soient les r\u00e9sultats (positifs ou n\u00e9gatifs). Ce r\u00e9sum\u00e9 sera r\u00e9dig\u00e9 de fa\u00e7on \u00e0 ce qu\u2019il soit compr\u00e9hensible par le public.
\nPour une utilisation optimale, l\u2019interface utilisateur de la base de donn\u00e9es sera disponible dans toutes les langues officielles de l\u2019UE.<\/p>\n

C. R\u00e9alisation des essais cliniques transfrontaliers<\/strong><\/h3>\n

Pour relancer la recherche europ\u00e9enne, des essais cliniques transfrontaliers pourront \u00eatre r\u00e9alis\u00e9s. Cela concerne notamment les maladies rares pour lesquelles il est difficile de regrouper les patients dans un seul pays. Ainsi, \u00e0 l\u2019\u00e9chelle europ\u00e9enne, les \u00e9chantillons de patients seront plus importants, ce qui permettra de d\u00e9velopper ou d\u2019am\u00e9liorer les traitements.<\/p>\n

D. Et puis sinon, quoi d\u2019autre\u00a0?<\/h3>\n

De nouvelles terminologies et d\u00e9finitions seront int\u00e9gr\u00e9es dans ce r\u00e8glement, de m\u00eame que la notion de \u00abrisque \u00bb (et oui, encore\u00a0!). Plus concr\u00e8tement, ce nouveau r\u00e8glement tiendra compte des diff\u00e9rents risques que font courir les essais cliniques<\/strong> aux participants (les essais non interventionnels ne sont pas concern\u00e9s). Ainsi, une nouvelle cat\u00e9gorie d\u2019essai clinique \u00ab\u00a0\u00e0 faible intervention\u00a0\u00bb sera cr\u00e9\u00e9e.<\/p>\n

Quant aux personnes dites \u00ab\u00a0vuln\u00e9rables\u00a0\u00bb, leur protection est \u00e9tendue dans le r\u00e8glement. Pour rappel, les personnes consid\u00e9r\u00e9es comme \u00ab\u00a0vuln\u00e9rables\u00a0\u00bb sont\u00a0les \u00ab\u00a0participants incapables, les mineurs, les femmes enceintes ou allaitantes, les participants des essais men\u00e9s dans des situations d\u2019urgence\u00a0\u00bb.<\/p>\n

De m\u00eame, la notion de caducit\u00e9 de l\u2019autorisation d\u2019essai clinique\u00a0est int\u00e9gr\u00e9e\u00a0: si aucun participant n\u2019a \u00e9t\u00e9 inclus dans les 2 ans suivant l\u2019autorisation de l\u2019essai, celle-ci sera consid\u00e9r\u00e9e comme caduque (\u00e0 noter que la dur\u00e9e \u00e9tait initialement de 1 an dans la pr\u00e9c\u00e9dente directive, comme l\u2019indique l\u2019article R1123-33<\/a> du Code de la Sant\u00e9 Publique).<\/p>\n

Pour r\u00e9sumer, l\u2019un des mots clefs de ce nouveau r\u00e8glement de 2014 est la Transparence des informations vis-\u00e0-vis du public. Pour y r\u00e9pondre, le portail unique de l\u2019UE\u00a0sera cr\u00e9\u00e9 pour permettre \u00e0 l\u2019Europe d\u2019acc\u00e9der plus rapidement \u00e0 l\u2019innovation, mais aussi de renforcer son attractivit\u00e9 face \u00e0 ses comp\u00e9titeurs mondiaux \u00a0tels que les Etats-Unis par exemple. Gr\u00e2ce \u00e0 cette nouvelle directive, un plus grand nombre de patients pourront b\u00e9n\u00e9ficier de traitements innovants, tout en garantissant leur s\u00e9curit\u00e9.<\/p>\n

Sources\u00a0:\u00a0ansm.sante.fr<\/em><\/p>\n

Si tu es d\u00e9butant ou en cours de formation d’ARC, n’oublie pas te participer au Challenge 2016 du blog<\/a> ! (Tu as jusqu’au 15 Janvier 2016 pour t’inscrire au concours)<\/em><\/p>\n

Tu peux te rendre sur la page Facebook du \u00ab\u00a0Blog de la Recherche Clinique\u00a0\u00bb et de \u00ab\u00a0Pharmaspecific\u00a0\u00bb et cliquer sur \u00ab\u00a0J\u2019aime\u00a0\u00bb pour faire partie de notre cercle de professionnels.<\/p>\n

Retrouve\u00a0\u00ab\u00a0Pharmaspecific\u00a0\u00bb et\u00a0\u00ab\u00a0Vanessa Montanari\u00a0\u00bb \u00a0sur LinkedIn pour avoir plus d\u2019\u2019actualit\u00e9s en recherche clinique en cliquant\u00a0ici<\/a>\u00a0et\u00a0ici
\n<\/a>Retrouve nous \u00e9galement sur Viadeo en cliquant\u00a0ici<\/a>\u00a0et\u00a0ici<\/a><\/p>\n

Tu peux \u00e9galement t\u2019inscrire \u00e0 la newsletter du blog, nous t\u2019informerons des nouveaux articles d\u00e8s qu\u2019ils seront post\u00e9s.<\/p>\n

\n

Vous avez besoin d\u2019une prestation en recherche clinique? contactez PHARMASPECIFIC en vous rendant sur notre site en cliquant ici : <\/i><\/b>https:\/\/pharmaspecific.com\/devis<\/i><\/b><\/span><\/a><\/span><\/p>\n

Si tu as des questions sur le m\u00e9tier d\u2019attach\u00e9 de recherche clinique ou sur une carri\u00e8re dans la recherche clinique, tu peux la mettre dans les commentaires ci-dessous. Nous te r\u00e9pondrons dans les plus brefs d\u00e9lais.<\/i><\/span><\/p>\n

Si tu veux \u00eatre coach\u00e9, si tu veux une r\u00e9ponse personnalis\u00e9e \u00e0 tes questions ou \u00eatre en contact avec d\u2019autres professionnels de la recherche clinique, tu peux te rendre sur <\/i>https:\/\/pharmaspecific-training.com\/<\/i><\/span><\/a><\/span><\/p>","protected":false},"excerpt":{"rendered":"

Te souviens-tu que l\u2019ann\u00e9e derni\u00e8re, la Directive Europ\u00e9enne de 2001 (2001\/20\/CE) avait \u00e9t\u00e9 abrog\u00e9e par le r\u00e8glement europ\u00e9en de 2014\u00a0? Ce nouveau r\u00e8glement, applicable aux essais cliniques de m\u00e9dicaments \u00e0 usage humain, entrera en application en 2016. Mais au fait, qu\u2019a-t-il de plus que la directive de 2001 exactement\u00a0?<\/p>","protected":false},"author":4,"featured_media":13918,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"om_disable_all_campaigns":false,"rop_custom_images_group":[],"rop_custom_messages_group":[],"rop_publish_now":"initial","rop_publish_now_accounts":{"facebook_122143508198123560_331463380343150":""},"rop_publish_now_history":[],"rop_publish_now_status":"pending","_sitemap_exclude":false,"_sitemap_priority":"","_sitemap_frequency":"","_exactmetrics_skip_tracking":false,"_exactmetrics_sitenote_active":false,"_exactmetrics_sitenote_note":"","_exactmetrics_sitenote_category":0,"_jetpack_memberships_contains_paid_content":false,"footnotes":""},"categories":[389],"tags":[16,66,46,206,110],"class_list":["post-13915","post","type-post","status-publish","format-standard","has-post-thumbnail","category-reglementaires","tag-arc","tag-attache-de-recherche-clinique","tag-chef-de-projet-clinique","tag-directive-europeenne","tag-emploi-attache-de-recherche-clinique"],"translation":{"provider":"WPGlobus","version":"3.0.2","language":"en","enabled_languages":["fr","en"],"languages":{"fr":{"title":true,"content":true,"excerpt":true},"en":{"title":false,"content":false,"excerpt":false}}},"yoast_head":"\nLa Directive Europ\u00e9enne de 2014<\/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:\/\/blogdelarechercheclinique.com\/en\/points-importants-du-nouveau-reglement-europeen-2014\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Les points importants du nouveau r\u00e8glement europ\u00e9en de 2014 - Blog de la recherche\" \/>\n<meta property=\"og:url\" content=\"https:\/\/blogdelarechercheclinique.com\/en\/points-importants-du-nouveau-reglement-europeen-2014\/\" \/>\n<meta property=\"og:site_name\" content=\"Blog de la recherche\" \/>\n<meta property=\"article:publisher\" content=\"https:\/\/www.facebook.com\/blogdelarechercheclinique\" \/>\n<meta property=\"article:published_time\" content=\"2015-11-25T15:00:30+00:00\" \/>\n<meta property=\"article:modified_time\" 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