Le document, dat\u00e9 du 9 octobre 2026 et \u00e9mis par la division des m\u00e9dicaments \u00e0 usage humain de l\u2019Agence europ\u00e9enne des m\u00e9dicaments (EMA), pr\u00e9sente une version r\u00e9vis\u00e9e (Rev. 3) d\u2019un guide de questions-r\u00e9ponses consacr\u00e9 \u00e0 la proc\u00e9dure de v\u00e9rification de la conformit\u00e9 aux plans d\u2019investigation p\u00e9diatrique (PIP) ainsi qu\u2019aux m\u00e9canismes de r\u00e9compense pr\u00e9vus par la r\u00e9glementation p\u00e9diatrique europ\u00e9enne. Il s\u2019adresse aux demandeurs de mises sur le march\u00e9 de m\u00e9dicaments et pr\u00e9cise en particulier la notion de \u00ab validation p\u00e9diatrique \u00bb d\u2019une demande d\u2019autorisation de mise sur le march\u00e9 (AMM), de variation ou d\u2019extension d\u2019AMM, ainsi que les modalit\u00e9s de contr\u00f4le de conformit\u00e9 \u00e0 un PIP approuv\u00e9, condition pr\u00e9alable \u00e0 l\u2019octroi de certaines r\u00e9compenses r\u00e9glementaires.<\/p>\n
Le texte indique que les principales \u00e9volutions par rapport \u00e0 la version ant\u00e9rieure concernent des mises \u00e0 jour des lignes directrices de soumission. Il renvoie \u00e0 plusieurs cadres juridiques europ\u00e9ens de r\u00e9f\u00e9rence : le r\u00e8glement (CE) n\u00b0 1901\/2006 sur les m\u00e9dicaments \u00e0 usage p\u00e9diatrique, modifi\u00e9 par le r\u00e8glement (CE) n\u00b0 1902\/2006, qui constitue la base de la \u00ab r\u00e9glementation p\u00e9diatrique \u00bb ; les lignes directrices de la Commission europ\u00e9enne sur le format et le contenu des demandes d\u2019accord ou de modification d\u2019un PIP et sur le fonctionnement du contr\u00f4le de conformit\u00e9 ; la notice aux demandeurs (EudraLex, volume 2B, module 1) relative aux informations administratives et au formulaire de demande ; le r\u00e8glement (CE) n\u00b0 1234\/2008 encadrant l\u2019examen des variations des termes d\u2019AMM ; et le r\u00e8glement (CE) n\u00b0 469\/2009 relatif aux certificats compl\u00e9mentaires de protection pour les m\u00e9dicaments, qui est li\u00e9 aux r\u00e9compenses potentielles pour les \u00e9tudes p\u00e9diatriques.<\/p>\n
Le document pr\u00e9cise les principaux acteurs institutionnels en charge de ces proc\u00e9dures : les autorit\u00e9s comp\u00e9tentes nationales pour les m\u00e9dicaments autoris\u00e9s par les proc\u00e9dures nationale, de reconnaissance mutuelle ou d\u00e9centralis\u00e9e, et l\u2019EMA avec la Commission europ\u00e9enne pour les m\u00e9dicaments relevant de la proc\u00e9dure centralis\u00e9e. Il d\u00e9finit \u00e9galement les notions utiles pour les op\u00e9rateurs et pour le suivi des politiques publiques, notamment le PIP (plan d\u2019investigation p\u00e9diatrique) et la notion de \u00ab demande r\u00e9glementaire \u00bb, qui couvre les demandes d\u2019AMM, d\u2019extension d\u2019AMM et de variation. L\u2019ensemble s\u2019inscrit dans le cadre de la mise en \u0153uvre et de l\u2019actualisation du dispositif europ\u00e9en visant \u00e0 encadrer le d\u00e9veloppement et l\u2019\u00e9valuation des m\u00e9dicaments pour la population p\u00e9diatrique, avec des implications directes pour les conditions d\u2019acc\u00e8s au march\u00e9 et les incitations r\u00e9glementaires accord\u00e9es aux industriels. (contenu r\u00e9sum\u00e9 en fran\u00e7ais par l’IA)\u00a0\u200bLire la Suite<\/a><\/p>","protected":false},"excerpt":{"rendered":" Le document, dat\u00e9 du 9 octobre 2026 et \u00e9mis par la division des m\u00e9dicaments \u00e0 usage humain de l\u2019Agence europ\u00e9enne des m\u00e9dicaments (EMA), pr\u00e9sente une version r\u00e9vis\u00e9e (Rev. 3) d\u2019un […]<\/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-20449","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\/20449","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=20449"}],"version-history":[{"count":0,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=\/wp\/v2\/posts\/20449\/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=20449"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=20449"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=20449"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}