Le document \u00e9mane de l\u2019Agence europ\u00e9enne des m\u00e9dicaments (EMA), plus pr\u00e9cis\u00e9ment du Comit\u00e9 des m\u00e9dicaments v\u00e9t\u00e9rinaires (CVMP) et de son groupe de travail sur la pharmacovigilance (PhVWP). Il s\u2019agit d\u2019une mise \u00e0 jour, dat\u00e9e du 18 juin 2026, de notes d\u2019orientation relatives \u00e0 l\u2019utilisation de la terminologie VeDDRA (Veterinary Dictionary for Drug Related Affairs) pour la d\u00e9claration des effets ind\u00e9sirables suspect\u00e9s chez les animaux et chez l\u2019humain. L\u2019entr\u00e9e en vigueur de cette version est fix\u00e9e au 1er octobre 2026, en lien avec la version 22 de la mise en \u0153uvre EVVet.<\/p>\n
VeDDRA est d\u00e9crite comme une terminologie structur\u00e9e pour la pharmacovigilance v\u00e9t\u00e9rinaire, organis\u00e9e selon une hi\u00e9rarchie \u00e0 quatre niveaux : classe de syst\u00e8mes d\u2019organes (SOC), terme de haut niveau (HLT), terme pr\u00e9f\u00e9r\u00e9 (PT) et terme de bas niveau (LLT). La relation entre SOC et LLT est mono-axiale : chaque LLT n\u2019appartient qu\u2019\u00e0 une seule SOC. Lorsque des termes proches existent dans d\u2019autres SOC, des renvois crois\u00e9s sont pr\u00e9vus. Les intitul\u00e9s au niveau des SOC et des HLT sont au pluriel, alors que les PT et LLT sont au singulier, sauf exception m\u00e9dicale. Tout PT est \u00e9galement disponible comme LLT.<\/p>\n
Le document pr\u00e9cise que les LLT peuvent \u00eatre soit des synonymes, soit des sous-cat\u00e9gories d\u2019un PT. Un exemple est donn\u00e9 avec le PT \u00ab Anaphylaxis \u00bb, qui regroupe les LLT \u00ab Anaphylaxis \u00bb et \u00ab Anaphylactoid reaction \u00bb. La s\u00e9lection des termes pour d\u00e9crire un effet ind\u00e9sirable doit se faire au niveau LLT, en ad\u00e9quation avec les signes cliniques rapport\u00e9s, tout en veillant \u00e0 ce que le PT et la SOC correspondants soient pertinents pour l\u2019analyse. Les LLT comportant la mention \u00ab NOS \u00bb (not otherwise specified) ne doivent \u00eatre utilis\u00e9s que lorsqu\u2019aucun terme plus sp\u00e9cifique n\u2019est disponible. L\u2019analyse des donn\u00e9es de pharmacovigilance est en principe r\u00e9alis\u00e9e au niveau PT.<\/p>\n
Les notes signalent que diverses situations peuvent conduire \u00e0 plusieurs choix possibles de LLT, parfois entra\u00eenant des classements diff\u00e9rents au niveau des SOC. L\u2019objectif affich\u00e9 n\u2019est pas de restreindre ces choix, mais de promouvoir une approche harmonis\u00e9e afin de garantir la coh\u00e9rence et la validit\u00e9 des analyses des effets ind\u00e9sirables. Le texte rappelle \u00e9galement que, lorsque les signes cliniques sont clairement ant\u00e9rieurs \u00e0 l\u2019administration du produit ou imputables \u00e0 la maladie trait\u00e9e ou \u00e0 une autre cause identifi\u00e9e, ceci doit \u00eatre pris en compte lors du codage.<\/p>\n
Du point de vue des politiques publiques, ce document illustre un cadre europ\u00e9en harmonis\u00e9 pour la collecte et l\u2019analyse des donn\u00e9es de pharmacovigilance v\u00e9t\u00e9rinaire, incluant les \u00e9v\u00e9nements chez l\u2019humain en lien avec ces m\u00e9dicaments. Il peut servir de r\u00e9f\u00e9rence pour les autorit\u00e9s nationales de s\u00e9curit\u00e9 sanitaire et de pharmacovigilance v\u00e9t\u00e9rinaire, en particulier pour aligner les pratiques de codage et de reporting sur les standards europ\u00e9ens en vigueur \u00e0 compter d\u2019octobre 2026. (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), plus pr\u00e9cis\u00e9ment du Comit\u00e9 des m\u00e9dicaments v\u00e9t\u00e9rinaires (CVMP) et de son groupe de travail sur la pharmacovigilance (PhVWP). Il s\u2019agit d\u2019une […]<\/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-17741","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\/17741","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=17741"}],"version-history":[{"count":0,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=\/wp\/v2\/posts\/17741\/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=17741"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=17741"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=17741"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}