Le document \u00e9mane de l\u2019Agence europ\u00e9enne des m\u00e9dicaments (EMA), agence de l\u2019Union europ\u00e9enne situ\u00e9e \u00e0 Amsterdam (Pays-Bas), et concerne une proc\u00e9dure de coordination des inspections des Bonnes Pratiques Cliniques (BPC, \u00ab GCP \u00bb) demand\u00e9es par le Comit\u00e9 des m\u00e9dicaments \u00e0 usage humain (CHMP). Cette proc\u00e9dure, r\u00e9f\u00e9renc\u00e9e EMA\/INS\/GCP\/55482\/2013 \u2013 R\u00e9v.1, rel\u00e8ve de la division \u00ab Human Medicines Division \u2013 Quality and Safety of Medicines \u00bb. Elle s\u2019applique \u00e0 l\u2019EMA et aux autorit\u00e9s d\u2019inspection des \u00c9tats membres de l\u2019UE\/EEE (National Competent Authorities \u2013 NCAs).<\/p>\n
Le texte pr\u00e9cise que la proc\u00e9dure a \u00e9t\u00e9 initialement adopt\u00e9e par le groupe de travail des inspecteurs BPC (GCP Inspectors\u2019 Working Group \u2013 GCP IWG) le 18 mars 2014, puis par le CHMP le 20 mars 2014, date \u00e9galement de son entr\u00e9e en vigueur. Une r\u00e9vision est dat\u00e9e du 17 juin 2026, rempla\u00e7ant la proc\u00e9dure ant\u00e9rieure INS\/GCP\/1 (r\u00e9f\u00e9rence EMEA\/INS\/GCP\/197225\/2005). Le document est publi\u00e9 par l\u2019EMA, qui en autorise la reproduction sous r\u00e9serve de mention de la source.<\/p>\n
La proc\u00e9dure vise \u00e0 encadrer la coordination des inspections BPC, en particulier lorsqu\u2019elles sont demand\u00e9es par le CHMP dans le cadre de l\u2019\u00e9valuation des m\u00e9dicaments \u00e0 usage humain. Elle d\u00e9finit le champ d\u2019application, les \u00e9tapes de la proc\u00e9dure et un ensemble de termes op\u00e9rationnels relatifs \u00e0 l\u2019organisation des inspections. Sont ainsi pr\u00e9cis\u00e9s les r\u00f4les respectifs de diff\u00e9rentes cat\u00e9gories d\u2019acteurs : l\u2019inspectorat rapporteur (\u00ab reporting inspectorate \u00bb) et l\u2019inspecteur rapporteur (\u00ab reporting inspector \u00bb) charg\u00e9s de la conduite et du rapport de l\u2019inspection, l\u2019inspecteur principal (\u00ab lead inspector \u00bb), les inspectorats et inspecteurs de soutien (\u00ab supporting inspectorate \u00bb, \u00ab supporting inspector \u00bb), l\u2019inspecteur stagiaire (\u00ab trainee inspector \u00bb), l\u2019observateur, ainsi que le coordinateur des inspections au sein de l\u2019EMA (\u00ab EMA inspection coordinator \u00bb). Le document distingue notamment la notion de proc\u00e9dure d\u2019inspection, d\u2019inspection de site (\u00ab site inspection \u00bb) et pr\u00e9cise que la proc\u00e9dure s\u2019applique aux autorit\u00e9s et inspecteurs concern\u00e9s au sein de l\u2019UE\/EEE.<\/p>\n
Le contenu disponible indique que la proc\u00e9dure comprend un r\u00e9sum\u00e9 de son champ d\u2019application, une introduction, une section sur l\u2019applicabilit\u00e9 et les d\u00e9finitions, puis la description des \u00e9tapes de la proc\u00e9dure d\u2019inspection. Les pays et acteurs concern\u00e9s sont l\u2019ensemble des \u00c9tats membres de l\u2019UE\/EEE via leurs autorit\u00e9s nationales comp\u00e9tentes d\u2019inspection, l\u2019EMA, le CHMP et le groupe de travail des inspecteurs BPC. L\u2019enjeu principal est l\u2019harmonisation et la coordination des inspections BPC au niveau europ\u00e9en pour les essais cliniques li\u00e9s aux m\u00e9dicaments \u00e0 usage humain, avec des implications en mati\u00e8re de qualit\u00e9 et de s\u00e9curit\u00e9 des m\u00e9dicaments et de surveillance r\u00e9glementaire. Aucune information chiffr\u00e9e ni \u00e9l\u00e9ment d\u00e9taill\u00e9 sur le contenu op\u00e9rationnel des \u00e9tapes n\u2019est fourni dans l\u2019extrait disponible. (contenu r\u00e9sum\u00e9 en fran\u00e7ais par l’IA)\u00a0\u200bLire la Suite<\/a><\/p>","protected":false},"excerpt":{"rendered":" Le document \u00e9mane de l\u2019Agence europ\u00e9enne des m\u00e9dicaments (EMA), agence de l\u2019Union europ\u00e9enne situ\u00e9e \u00e0 Amsterdam (Pays-Bas), et concerne une proc\u00e9dure de coordination des inspections des Bonnes Pratiques Cliniques (BPC, […]<\/p>\n","protected":false},"author":1,"featured_media":17698,"comment_status":"","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"site-sidebar-layout":"default","site-content-layout":"","ast-site-content-layout":"default","site-content-style":"default","site-sidebar-style":"default","ast-global-header-display":"","ast-banner-title-visibility":"","ast-main-header-display":"","ast-hfb-above-header-display":"","ast-hfb-below-header-display":"","ast-hfb-mobile-header-display":"","site-post-title":"","ast-breadcrumbs-content":"","ast-featured-img":"","footer-sml-layout":"","ast-disable-related-posts":"","theme-transparent-header-meta":"","adv-header-id-meta":"","stick-header-meta":"","header-above-stick-meta":"","header-main-stick-meta":"","header-below-stick-meta":"","astra-migrate-meta-layouts":"default","ast-page-background-enabled":"default","ast-page-background-meta":{"desktop":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"ast-content-background-meta":{"desktop":{"background-color":"var(--ast-global-color-4)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"var(--ast-global-color-4)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"var(--ast-global-color-4)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"footnotes":""},"categories":[36,31],"tags":[257,227,226],"class_list":["post-18681","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-droit-social-sante-travail-et-securite-sociale","category-politiques-europeennes-sante-social-travail","tag-ema","tag-ia","tag-sources-etrangeres"],"_links":{"self":[{"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=\/wp\/v2\/posts\/18681","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=18681"}],"version-history":[{"count":0,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=\/wp\/v2\/posts\/18681\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=\/wp\/v2\/media\/17698"}],"wp:attachment":[{"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=18681"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=18681"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=18681"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}