{"id":383,"date":"2024-04-25T10:07:50","date_gmt":"2024-04-25T10:07:50","guid":{"rendered":"http:\/\/annualreport.edqm.eu\/?page_id=383"},"modified":"2024-06-10T20:41:54","modified_gmt":"2024-06-10T20:41:54","slug":"european-network-of-official-medicines-control-laboratories","status":"publish","type":"page","link":"https:\/\/annualreport2023.edqm.eu\/fr\/european-network-of-official-medicines-control-laboratories\/","title":{"rendered":"R\u00e9seau europ\u00e9en des laboratoires officiels de contr\u00f4le des m\u00e9dicaments"},"content":{"rendered":"<div data-elementor-type=\"wp-page\" data-elementor-id=\"383\" class=\"elementor elementor-383\" data-elementor-post-type=\"page\">\n\t\t\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-4561873 elementor-section-height-min-height elementor-section-stretched elementor-section-boxed elementor-section-height-default elementor-section-items-middle elementor-invisible\" data-id=\"4561873\" data-element_type=\"section\" data-settings=\"{&quot;stretch_section&quot;:&quot;section-stretched&quot;,&quot;background_background&quot;:&quot;classic&quot;,&quot;animation&quot;:&quot;fadeInDown&quot;}\">\n\t\t\t\t\t\t\t<div class=\"elementor-background-overlay\"><\/div>\n\t\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-5ee69826\" data-id=\"5ee69826\" data-element_type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-280dea8 elementor-widget elementor-widget-heading\" data-id=\"280dea8\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Quality &amp; use of medicines<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-c41e3ef elementor-section-stretched animated-slow elementor-section-boxed elementor-section-height-default elementor-section-height-default elementor-invisible\" data-id=\"c41e3ef\" data-element_type=\"section\" data-settings=\"{&quot;stretch_section&quot;:&quot;section-stretched&quot;,&quot;animation&quot;:&quot;fadeIn&quot;}\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-fb2fe31\" data-id=\"fb2fe31\" data-element_type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-482f239 elementor-widget elementor-widget-heading\" data-id=\"482f239\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h1 class=\"elementor-heading-title elementor-size-default\">R\u00e9seau europ\u00e9en des laboratoires officiels de contr\u00f4le des m\u00e9dicaments<\/h1>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<section class=\"elementor-section elementor-inner-section elementor-element elementor-element-7278ec94 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"7278ec94\" data-element_type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-50 elementor-inner-column elementor-element elementor-element-7c5e03bd\" data-id=\"7c5e03bd\" data-element_type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-6c67758 elementor-widget elementor-widget-text-editor\" data-id=\"6c67758\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p><strong>Le r\u00e9seau europ\u00e9en des laboratoires officiels de contr\u00f4le des m\u00e9dicaments (OMCL) r\u00e9unit les laboratoires officiels de 34 \u00c9tats membres europ\u00e9ens et de sept pays non europ\u00e9ens. Ensemble, ils veillent \u00e0 la qualit\u00e9 des m\u00e9dicaments pr\u00e9sents sur le march\u00e9 et \u00e9vitent que des m\u00e9dicaments de qualit\u00e9 inf\u00e9rieure ou falsifi\u00e9s parviennent aux utilisatrices ou utilisateurs finaux, et assurent ainsi la protection de la sant\u00e9 des personnes soign\u00e9es en garantissant des traitements efficaces et sans danger.<\/strong><\/p><p><strong>L\u2019EDQM coordonne les activit\u00e9s et le programme de travail du r\u00e9seau g\u00e9n\u00e9ral europ\u00e9en des OMCL (GEON), cofinanc\u00e9 par l\u2019UE. En 2023, les membres du r\u00e9seau ont fait preuve, encore une fois, de flexibilit\u00e9 et de r\u00e9silience en r\u00e9organisant et red\u00e9ployant les ressources afin de surmonter diverses difficult\u00e9s logistiques, \u00e9conomiques et politiques.<\/strong><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-c21b074 elementor-widget elementor-widget-image\" data-id=\"c21b074\" data-element_type=\"widget\" data-widget_type=\"image.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<img fetchpriority=\"high\" decoding=\"async\" width=\"870\" height=\"165\" src=\"https:\/\/annualreport2023.edqm.eu\/wp-content\/uploads\/2024\/04\/Funded-EU-and-COE-Implemented-COE-quadri-en.png\" class=\"attachment-full size-full wp-image-357\" alt=\"\" srcset=\"https:\/\/annualreport2023.edqm.eu\/wp-content\/uploads\/2024\/04\/Funded-EU-and-COE-Implemented-COE-quadri-en.png 870w, https:\/\/annualreport2023.edqm.eu\/wp-content\/uploads\/2024\/04\/Funded-EU-and-COE-Implemented-COE-quadri-en-300x57.png 300w, https:\/\/annualreport2023.edqm.eu\/wp-content\/uploads\/2024\/04\/Funded-EU-and-COE-Implemented-COE-quadri-en-768x146.png 768w\" sizes=\"(max-width: 870px) 100vw, 870px\" \/>\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t<div class=\"elementor-column elementor-col-50 elementor-inner-column elementor-element elementor-element-766b9eaf\" data-id=\"766b9eaf\" data-element_type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-3dbb777a elementor-widget elementor-widget-image\" data-id=\"3dbb777a\" data-element_type=\"widget\" data-widget_type=\"image.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<img decoding=\"async\" width=\"1000\" height=\"563\" src=\"https:\/\/annualreport2023.edqm.eu\/wp-content\/uploads\/2024\/06\/04-OMCLs.jpg\" class=\"attachment-full size-full wp-image-850\" alt=\"\" srcset=\"https:\/\/annualreport2023.edqm.eu\/wp-content\/uploads\/2024\/06\/04-OMCLs.jpg 1000w, https:\/\/annualreport2023.edqm.eu\/wp-content\/uploads\/2024\/06\/04-OMCLs-300x169.jpg 300w, https:\/\/annualreport2023.edqm.eu\/wp-content\/uploads\/2024\/06\/04-OMCLs-768x432.jpg 768w, https:\/\/annualreport2023.edqm.eu\/wp-content\/uploads\/2024\/06\/04-OMCLs-800x450.jpg 800w\" sizes=\"(max-width: 1000px) 100vw, 1000px\" \/>\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-ed3aafc elementor-section-stretched animated-slow elementor-section-boxed elementor-section-height-default elementor-section-height-default elementor-invisible\" data-id=\"ed3aafc\" data-element_type=\"section\" data-settings=\"{&quot;stretch_section&quot;:&quot;section-stretched&quot;,&quot;background_background&quot;:&quot;classic&quot;,&quot;animation&quot;:&quot;fadeIn&quot;}\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-cf68d1f\" data-id=\"cf68d1f\" data-element_type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-b17e6b2 elementor-widget elementor-widget-heading\" data-id=\"b17e6b2\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h3 class=\"elementor-heading-title elementor-size-default\">Management de la qualit\u00e9<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-969cc15 elementor-widget elementor-widget-heading\" data-id=\"969cc15\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h4 class=\"elementor-heading-title elementor-size-default\">Programme de travail<\/h4>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-6f124e2 elementor-widget elementor-widget-text-editor\" data-id=\"6f124e2\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p><strong>Programme d\u2019audits mutuels conjoints\/visites mutuelles conjointes (AMC\/VMC) et de visites de formation (VF)<\/strong><\/p><p>L\u2019harmonisation des syst\u00e8mes de management de la qualit\u00e9 entre OMCL et l\u2019atteinte de niveaux de qualit\u00e9 appropri\u00e9s demeurent les objectifs principaux de ce programme d\u2019audit. L\u2019id\u00e9e est de permettre la reconnaissance mutuelle des r\u00e9sultats exp\u00e9rimentaux entre membres : essais de lib\u00e9ration officielle des lots de produits biologiques, surveillance du march\u00e9 des m\u00e9dicaments autoris\u00e9s et analyse des m\u00e9dicaments falsifi\u00e9s, par exemple.<\/p><p>En 2023, il a, de nouveau, \u00e9t\u00e9 possible de mener des \u00e9valuations sur site, dans les laboratoires, tout en continuant \u00e0 effectuer des \u00e9valuations \u00e0 distance chaque fois que n\u00e9cessaire.<\/p><p>En tout, 15 AMC de r\u00e9\u00e9valuation compl\u00e8te, un AMC de surveillance et une VF ont \u00e9t\u00e9 r\u00e9alis\u00e9s. Depuis le lancement du programme de management de la qualit\u00e9 pour les OMCL, en 1997, 239 AMC, 52 VMC et 28 VF\/tutoriels ont \u00e9t\u00e9 men\u00e9s.<\/p><p><strong>Formations\/ateliers<\/strong><\/p><p>L\u2019EDQM a organis\u00e9 un atelier pratique de deux jours, intitul\u00e9 \u00ab Evaluation and Reporting of Results \u00bb, pour aider ses partenaires travaillant dans les OMCL \u00e0 comprendre et \u00e0 mettre en application les exigences d\u00e9finies dans la norme ISO\/CEI 17025:2017.<\/p><p><strong>Essais d\u2019aptitude (PTS)<\/strong><\/p><p>Le programme d\u2019essais d\u2019aptitude (PTS) de l\u2019EDQM offre aux laboratoires un moyen objectif d\u2019\u00e9valuer et de d\u00e9montrer la fiabilit\u00e9 de leurs donn\u00e9es. En 2023, cinq \u00e9tudes physicochimiques et cinq \u00e9tudes biologiques ont \u00e9t\u00e9 r\u00e9alis\u00e9es.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<section class=\"elementor-section elementor-inner-section elementor-element elementor-element-f3ffb7d elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"f3ffb7d\" data-element_type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-50 elementor-inner-column elementor-element elementor-element-6a632f0\" data-id=\"6a632f0\" data-element_type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-795277c elementor-widget elementor-widget-heading\" data-id=\"795277c\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h4 class=\"elementor-heading-title elementor-size-default\">Coop\u00e9ration internationale<\/h4>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-5038f28 elementor-widget elementor-widget-text-editor\" data-id=\"5038f28\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>L\u2019EDQM est une intervenante \u00e0 part enti\u00e8re (\u00ab <em>recognised stakeholder<\/em> \u00bb) de la Coop\u00e9ration europ\u00e9enne pour l\u2019accr\u00e9ditation (EA). Elle participe r\u00e9guli\u00e8rement aux r\u00e9unions du Comit\u00e9 du laboratoire de l\u2019EA (EA\/LC) afin de renforcer sa collaboration avec les membres de ce comit\u00e9, de clarifier les questions techniques d\u2019int\u00e9r\u00eat pour le r\u00e9seau OMCL li\u00e9es \u00e0 l\u2019interpr\u00e9tation des exigences de la norme ISO\/CEI 17025:2017.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t<div class=\"elementor-column elementor-col-50 elementor-inner-column elementor-element elementor-element-2f3b760\" data-id=\"2f3b760\" data-element_type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-990e51c elementor-widget elementor-widget-heading\" data-id=\"990e51c\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h4 class=\"elementor-heading-title elementor-size-default\">Publications, bases de donn\u00e9es et site web<\/h4>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-cf0184f elementor-widget elementor-widget-text-editor\" data-id=\"cf0184f\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p class=\"translation-block\">Des <em>guidelines<\/em> de management de la qualit\u00e9 (MQ) communs visant \u00e0 aider les laboratoires \u00e0 se conformer aux exigences de la norme ISO\/CEI 17025:2017 sont r\u00e9dig\u00e9s par des expert\u00b7es du r\u00e9seau, et r\u00e9guli\u00e8rement mis \u00e0 jour, sous la coordination du Secr\u00e9tariat de l\u2019EDQM. En 2023, sept guidelines ou documents de recommandation ont \u00e9t\u00e9 publi\u00e9s ; deux autres documents sont en cours de r\u00e9vision (voir tableau <span style=\"color: #ffffff\"><a style=\"color: #ffffff\" href=\"#qm-table-fr\" target=\"_self\"><span style=\"text-decoration: underline\"><em>Documents de management de la qualit\u00e9 \u00e9labor\u00e9s en 2023<\/em><\/span><\/a><\/span>).<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-e4fff5b elementor-section-stretched animated-slow elementor-section-boxed elementor-section-height-default elementor-section-height-default elementor-invisible\" data-id=\"e4fff5b\" data-element_type=\"section\" data-settings=\"{&quot;stretch_section&quot;:&quot;section-stretched&quot;,&quot;animation&quot;:&quot;fadeIn&quot;}\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-50318a1\" data-id=\"50318a1\" data-element_type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-dfd8eef elementor-widget elementor-widget-heading\" data-id=\"dfd8eef\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h3 class=\"elementor-heading-title elementor-size-default\">Activit\u00e9s du GEON<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-296c791 elementor-widget elementor-widget-heading\" data-id=\"296c791\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h4 class=\"elementor-heading-title elementor-size-default\">Programme de travail<\/h4>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<section class=\"elementor-section elementor-inner-section elementor-element elementor-element-1133dd3 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"1133dd3\" data-element_type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-50 elementor-inner-column elementor-element elementor-element-d91cb40\" data-id=\"d91cb40\" data-element_type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-04bcf6d elementor-widget elementor-widget-text-editor\" data-id=\"04bcf6d\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p><strong>Assembl\u00e9e g\u00e9n\u00e9rale annuelle du GEON<\/strong><\/p><p>L\u2019assembl\u00e9e g\u00e9n\u00e9rale annuelle du GEON s\u2019est tenue en pr\u00e9sentiel, du 5 au 9 juin 2023, \u00e0 Madrid. Plus de 260 personnes ont particip\u00e9 aux neuf sessions propos\u00e9es. Les quatre objectifs strat\u00e9giques du r\u00e9seau, illustr\u00e9s par des exemples sp\u00e9cifiques, ont de nouveau servi de fil conducteur tout au long de la semaine.<\/p><p>Des th\u00e8mes pr\u00e9cis ont \u00e9t\u00e9 abord\u00e9s, notamment l\u2019application des techniques d\u2019\u00e9lectrophor\u00e8se capillaire dans les OMCL \u00e0 des fins analytiques vari\u00e9es. La collaboration a \u00e9galement \u00e9t\u00e9 un sujet d\u2019attention, avec des exemples de soutien par la formation et d\u2019\u00e9change d\u2019informations \u00e0 l\u2019initiative individuelle de membres du r\u00e9seau. Par ailleurs, une nouvelle pr\u00e9sidence et quelques membres du Comit\u00e9 consultatif du GEON ont \u00e9t\u00e9 \u00e9lu\u00b7es pendant la session g\u00e9n\u00e9rale.<\/p><p><strong>\u00c9tudes g\u00e9n\u00e9rales de surveillance du march\u00e9<\/strong><\/p><p>En 2023, deux \u00e9tudes de surveillance du march\u00e9 (MSS) ont \u00e9t\u00e9 cl\u00f4tur\u00e9es : l\u2019\u00e9tude MSS060 qui portait sur l\u2019olanzapine (substance active et comprim\u00e9s) et l\u2019\u00e9tude MSS061 qui couvrait la casse des ampoules de verre. Une nouvelle MSS sur la rosuvastatine (substance active et comprim\u00e9s) (MSS063) a \u00e9galement \u00e9t\u00e9 lanc\u00e9e.<\/p><p><strong>Groupe de Travail API (Substances actives)<\/strong><\/p><p class=\"translation-block\">Les r\u00e9sultats de l\u2019\u00e9tude MSSFP005 portant sur des \u00e9chantillons de substance active de tadalafil ont \u00e9t\u00e9 publi\u00e9s dans la revue <a href=\"https:\/\/doi.org\/10.1016\/j.xphs.2023.05.015\" target=\"_blank\" rel=\"noopener\"><span style=\"text-decoration: underline\"><em>Journal of Pharmaceutical Sciences<\/em> (Deconinck et al. 2023)<\/span><\/a>. Des discussions ont \u00e9t\u00e9 amorc\u00e9es, au sein du r\u00e9seau, pour r\u00e9fl\u00e9chir \u00e0 la r\u00e9orientation de la port\u00e9e des \u00e9tudes <em>fingerprint<\/em>.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t<div class=\"elementor-column elementor-col-50 elementor-inner-column elementor-element elementor-element-d013901\" data-id=\"d013901\" data-element_type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-e9f5315 elementor-widget elementor-widget-text-editor\" data-id=\"e9f5315\" data-element_type=\"widget\" data-no-translation=\"\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<style>.elementor-element-e9f5315{display:none !important}<\/style>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-1d6dbd4 elementor-widget elementor-widget-text-editor\" data-id=\"1d6dbd4\" data-element_type=\"widget\" data-no-translation=\"\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p><strong>Groupe de Travail OMCL sur les m\u00e9dicaments falsifi\u00e9s<\/strong><\/p><p>La sixi\u00e8me \u00e9tude de surveillance du march\u00e9 sur des produits pr\u00e9sum\u00e9s ill\u00e9gaux (MSSIP) a \u00e9t\u00e9 cl\u00f4tur\u00e9e. Elle portait sur les modulateurs s\u00e9lectifs des r\u00e9cepteurs aux androg\u00e8nes (SARM), les modulateurs m\u00e9taboliques et les s\u00e9cr\u00e9tagogues de l\u2019hormone de croissance \u00e0 petites mol\u00e9cules utilis\u00e9s pour l\u2019am\u00e9lioration des performances sportives. Plus de 300 r\u00e9sultats ont \u00e9t\u00e9 recueillis aupr\u00e8s de 14 OMCL. Une grande vari\u00e9t\u00e9 de substances ont \u00e9t\u00e9 identifi\u00e9es par les OMCL, les plus fr\u00e9quemment rencontr\u00e9es \u00e9tant l\u2019ibutamoren, l\u2019ostarine et la cardarine.<\/p><p>La septi\u00e8me MSSIP sur les nootropes a \u00e9t\u00e9 lanc\u00e9e. Il a \u00e9t\u00e9 d\u00e9cid\u00e9 de lancer une nouvelle MSSIP sur les antibiotiques provenant de sources ill\u00e9gales en 2024.<\/p><p>Dans le cadre du programme de contr\u00f4le des produits inconnus suspects (SUP), une nouvelle \u00e9tude (SUP012) a \u00e9t\u00e9 amorc\u00e9e en 2023. Impliquant 29 OMCL, elle vise \u00e0 identifier la substance pr\u00e9sente dans un \u00e9chantillon en aveugle.<\/p><p><strong>Groupe de Travail OMCL sur les m\u00e9dicaments de th\u00e9rapie g\u00e9nique (GTWG)<\/strong><\/p><p class=\"translation-block\">Actuellement compos\u00e9 de 11 OMCL, le GTWG a tenu sa 13<sup>e<\/sup> r\u00e9union annuelle, accueillie par l\u2019Agence danoise du m\u00e9dicament, \u00e0 Copenhague. Les r\u00e9sultats de l\u2019\u00e9tude intitul\u00e9e \u00ab Validation of a qPCR method for determination of viral genome titres of AAV2-based vector preparations \u00bb ont \u00e9t\u00e9 publi\u00e9s dans <a href=\"https:\/\/pbiosn.edqm.eu\/app\/pbiosn\/search?chapter=165869&amp;title=2023\" target=\"_blank\" rel=\"noopener\"><em>Pharmeuropa Bio and Scientific Notes<\/em>\u00a0(Ridoux et al. 2023)<\/a>. Le GTWG a achev\u00e9 le livre blanc sur les difficult\u00e9s que pose le contr\u00f4le des m\u00e9dicaments de th\u00e9rapie g\u00e9nique (MTG) au sein du GEON. Des progr\u00e8s ont \u00e9galement \u00e9t\u00e9 r\u00e9alis\u00e9s en ce qui concerne la validation des m\u00e9thodes standardis\u00e9es relatives au contr\u00f4le qualit\u00e9 des vecteurs AAV (virus ad\u00e9noassoci\u00e9s).<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<div class=\"elementor-element elementor-element-22baff9 elementor-widget elementor-widget-heading\" data-id=\"22baff9\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h4 class=\"elementor-heading-title elementor-size-default\">Coop\u00e9ration internationale<\/h4>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-3e9b5f5 elementor-widget elementor-widget-text-editor\" data-id=\"3e9b5f5\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>Le Groupe de Travail OMCL sur les m\u00e9dicaments falsifi\u00e9s a poursuivi sa collaboration avec le R\u00e9seau europ\u00e9en des laboratoires des douanes (CLEN), chaque organisme ayant invit\u00e9 l\u2019autre \u00e0 participer \u00e0 des MSS ou \u00e0 des conf\u00e9rences\/symposiums organis\u00e9s par ses soins.<\/p><p>Des repr\u00e9sentant\u00b7es de l\u2019EDQM ont particip\u00e9 \u00e0 plusieurs r\u00e9unions et formations organis\u00e9es par l\u2019OMS et par l\u2019Agence de d\u00e9veloppement de l\u2019Union africaine \u2013 Nouveau partenariat pour le d\u00e9veloppement de l\u2019Afrique (AUDA-NEPAD), avec le soutien de divers partenaires internationaux, en vue de promouvoir le renforcement des capacit\u00e9s des OMCL africains.\u00a0<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-b6904e5 elementor-widget elementor-widget-heading\" data-id=\"b6904e5\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h4 class=\"elementor-heading-title elementor-size-default\">Publications, bases de donn\u00e9es et site web<\/h4>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-f5a2dfc elementor-widget elementor-widget-text-editor\" data-id=\"f5a2dfc\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>En 2023, deux documents g\u00e9n\u00e9raux du r\u00e9seau OMCL ont \u00e9t\u00e9 achev\u00e9s, et deux autres r\u00e9vis\u00e9s.<\/p><p>CombiStats est un outil de r\u00e9f\u00e9rence reconnu pour l\u2019analyse statistique des r\u00e9sultats de titrages biologiques, qui contribue \u00e0 la reconnaissance mutuelle des donn\u00e9es et des r\u00e9sultats par l\u2019ensemble des parties int\u00e9ress\u00e9es. En 2023, son utilisation, d\u00e9j\u00e0 r\u00e9pandue, est rest\u00e9e stable, avec 960 licences distribu\u00e9es. CombiStats est utilis\u00e9 dans 68 pays, dont la moiti\u00e9 en Europe.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-8aa3de0 elementor-section-stretched animated-slow elementor-section-boxed elementor-section-height-default elementor-section-height-default elementor-invisible\" data-id=\"8aa3de0\" data-element_type=\"section\" data-settings=\"{&quot;stretch_section&quot;:&quot;section-stretched&quot;,&quot;background_background&quot;:&quot;classic&quot;,&quot;animation&quot;:&quot;fadeIn&quot;}\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-6904f0e\" data-id=\"6904f0e\" data-element_type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-3a8933b elementor-widget elementor-widget-heading\" data-id=\"3a8933b\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h3 class=\"elementor-heading-title elementor-size-default\">Activit\u00e9s concernant sp\u00e9cifiquement les pays de l\u2019UE\/EEE<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-3711d2c elementor-widget elementor-widget-heading\" data-id=\"3711d2c\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h4 class=\"elementor-heading-title elementor-size-default\">Programme de travail<\/h4>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-3946e34 elementor-widget elementor-widget-text-editor\" data-id=\"3946e34\" data-element_type=\"widget\" data-no-translation=\"\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<style>.elementor-element-3946e34{display:none !important}<\/style>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-1654fc7 elementor-widget elementor-widget-text-editor\" data-id=\"1654fc7\" data-element_type=\"widget\" data-no-translation=\"\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p><strong>Surveillance du march\u00e9 des produits autoris\u00e9s selon la proc\u00e9dure centralis\u00e9e<\/strong><\/p><p>Le programme r\u00e9gulier couvrant les produits autoris\u00e9s selon la proc\u00e9dure centralis\u00e9e (CAP) porte sur une liste annuelle de produits pr\u00e9par\u00e9e par le Secr\u00e9tariat de l\u2019EMA, en collaboration avec les comit\u00e9s scientifiques de l\u2019Organisation, et avec la contribution finale du Comit\u00e9 consultatif OMCL CAP. En 2023, 38 m\u00e9dicaments pour usage humain, six m\u00e9dicaments pour usage v\u00e9t\u00e9rinaire et une substance active ont \u00e9t\u00e9 d\u00e9sign\u00e9s pour les contr\u00f4les.<\/p><p>Le programme de surveillance des g\u00e9n\u00e9riques CAP 2023 a couvert des produits contenant de la desloratadine, de l\u2019acide ibandronique et du p\u00e9m\u00e9trexed.<\/p><p>Les projets du programme de surveillance des biosimilaires CAP portant sur l\u2019\u00e9tanercept et le rituximab ont \u00e9t\u00e9 men\u00e9s \u00e0 bien.<\/p><p>Un autre programme de surveillance du march\u00e9 des CAP est consacr\u00e9 aux contr\u00f4les d\u2019authenticit\u00e9 des produits faisant l\u2019objet d\u2019une distribution parall\u00e8le. Trois produits ont \u00e9t\u00e9 contr\u00f4l\u00e9s dans ce cadre en 2023.<\/p><p>Les r\u00e9sultats ont montr\u00e9 que la grande majorit\u00e9 des produits contr\u00f4l\u00e9s \u00e9taient de la qualit\u00e9 attendue et conformes aux sp\u00e9cifications autoris\u00e9es. Au 31 d\u00e9cembre 2023, un seul r\u00e9sultat hors sp\u00e9cifications avait \u00e9t\u00e9 identifi\u00e9 et quelques probl\u00e8mes d\u2019ordre r\u00e9glementaire ou technique avaient \u00e9t\u00e9 signal\u00e9s et suivis par l\u2019EMA.<\/p><p><strong>Programme de surveillance apr\u00e8s commercialisation des produits autoris\u00e9s selon la proc\u00e9dure de reconnaissance mutuelle ou selon la proc\u00e9dure d\u00e9centralis\u00e9e<\/strong><\/p><p>L\u2019ann\u00e9e 2023 a vu se d\u00e9rouler le 19<sup>e<\/sup> programme r\u00e9gulier, avec quelque 1 300 projets de contr\u00f4le (cl\u00f4tur\u00e9s). Des rapports de contr\u00f4le ont \u00e9t\u00e9 produits par 28 OMCL et 15 % des produits contr\u00f4l\u00e9s \u00e9taient pour usage v\u00e9t\u00e9rinaire. Des probl\u00e8mes d\u2019ordre r\u00e9glementaire ont \u00e9t\u00e9 constat\u00e9s dans 0,5 % des projets. Dans 3,4 % des cas, un ou plusieurs r\u00e9sultats hors sp\u00e9cifications ont \u00e9t\u00e9 signal\u00e9s. Les OMCL impliqu\u00e9s dans cette activit\u00e9 se sont rencontr\u00e9s deux fois en 2023 (en juin et en novembre) pour \u00e9valuer le programme et discuter des moyens d\u2019optimiser leur collaboration.<\/p><p>En octobre 2023, le groupe de travail du r\u00e9seau Heads of Medicines Agencies (HMA) sur l\u2019outil d\u2019\u00e9valuation des risques apr\u00e8s commercialisation a organis\u00e9 une formation \u00e0 destination des personnes charg\u00e9es de l\u2019\u00e9valuation de la qualit\u00e9, en collaboration avec l\u2019Agence estonienne du m\u00e9dicament et l\u2019EU NTC (EU Network Training Centre). Des repr\u00e9sentant\u00b7es de 24 pays y ont particip\u00e9. Cette formation avait pour but de clarifier la finalit\u00e9 de l\u2019outil de recommandation d\u2019essai\/\u00e9valuation des risques avant autorisation, dans sa version actuelle, et son lien avec les programmes de surveillance apr\u00e8s commercialisation. En outre, le futur outil d\u2019\u00e9valuation des risques apr\u00e8s commercialisation a \u00e9t\u00e9 pr\u00e9sent\u00e9.<\/p><p><strong>Produits biologiques pour usage humain : lib\u00e9ration officielle des lots par les autorit\u00e9s de contr\u00f4le (OCABR)<\/strong><\/p><p>Les activit\u00e9s du r\u00e9seau cr\u00e9ent les conditions n\u00e9cessaires \u00e0 la reconnaissance mutuelle obligatoire de la lib\u00e9ration des lots de vaccins pour usage humain et de m\u00e9dicaments d\u00e9riv\u00e9s du sang et du plasma humains. Les OMCL examinent la qualit\u00e9 de chaque lot en effectuant des analyses et des \u00e9valuations de protocole.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<section class=\"elementor-section elementor-inner-section elementor-element elementor-element-42b85cb5 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"42b85cb5\" data-element_type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-33 elementor-inner-column elementor-element elementor-element-1a26947\" data-id=\"1a26947\" data-element_type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-3dd33a8c elementor-widget elementor-widget-image\" data-id=\"3dd33a8c\" data-element_type=\"widget\" data-widget_type=\"image.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<img decoding=\"async\" width=\"486\" height=\"583\" src=\"https:\/\/annualreport2023.edqm.eu\/wp-content\/uploads\/2024\/06\/Icon-06-OMCLs-Biologicals.png\" class=\"attachment-full size-full wp-image-785\" alt=\"\" srcset=\"https:\/\/annualreport2023.edqm.eu\/wp-content\/uploads\/2024\/06\/Icon-06-OMCLs-Biologicals.png 486w, https:\/\/annualreport2023.edqm.eu\/wp-content\/uploads\/2024\/06\/Icon-06-OMCLs-Biologicals-250x300.png 250w\" sizes=\"(max-width: 486px) 100vw, 486px\" \/>\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-22e5c143 elementor-widget elementor-widget-counter\" data-id=\"22e5c143\" data-element_type=\"widget\" data-widget_type=\"counter.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-counter\">\n\t\t\t<div class=\"elementor-counter-title\">lots finaux de vaccins pour usage humain et de m\u00e9dicaments d\u00e9riv\u00e9s du sang humain<\/div>\t\t\t<div class=\"elementor-counter-number-wrapper\">\n\t\t\t\t<span class=\"elementor-counter-number-prefix\"><\/span>\n\t\t\t\t<span class=\"elementor-counter-number\" data-duration=\"2000\" data-to-value=\"11895\" data-from-value=\"0\" data-delimiter=\" \">0<\/span>\n\t\t\t\t<span class=\"elementor-counter-number-suffix\"><\/span>\n\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t<div class=\"elementor-column elementor-col-33 elementor-inner-column elementor-element elementor-element-70181b57\" data-id=\"70181b57\" data-element_type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-4b2b509 elementor-widget elementor-widget-image\" data-id=\"4b2b509\" data-element_type=\"widget\" data-widget_type=\"image.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<img loading=\"lazy\" decoding=\"async\" width=\"486\" height=\"583\" src=\"https:\/\/annualreport2023.edqm.eu\/wp-content\/uploads\/2024\/06\/Icon-07-OMCLs-Biologicals.png\" class=\"attachment-full size-full wp-image-786\" alt=\"\" srcset=\"https:\/\/annualreport2023.edqm.eu\/wp-content\/uploads\/2024\/06\/Icon-07-OMCLs-Biologicals.png 486w, https:\/\/annualreport2023.edqm.eu\/wp-content\/uploads\/2024\/06\/Icon-07-OMCLs-Biologicals-250x300.png 250w\" sizes=\"(max-width: 486px) 100vw, 486px\" \/>\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-59bf3bc9 elementor-widget elementor-widget-counter\" data-id=\"59bf3bc9\" data-element_type=\"widget\" data-widget_type=\"counter.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-counter\">\n\t\t\t<div class=\"elementor-counter-title\">m\u00e9langes de plasma soumis \u00e0 des contr\u00f4les d\u2019innocuit\u00e9<\/div>\t\t\t<div class=\"elementor-counter-number-wrapper\">\n\t\t\t\t<span class=\"elementor-counter-number-prefix\"><\/span>\n\t\t\t\t<span class=\"elementor-counter-number\" data-duration=\"2000\" data-to-value=\"12460\" data-from-value=\"0\" data-delimiter=\" \">0<\/span>\n\t\t\t\t<span class=\"elementor-counter-number-suffix\"><\/span>\n\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t<div class=\"elementor-column elementor-col-33 elementor-inner-column elementor-element elementor-element-31422604\" data-id=\"31422604\" data-element_type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-138decc2 elementor-widget elementor-widget-image\" data-id=\"138decc2\" data-element_type=\"widget\" data-widget_type=\"image.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<img loading=\"lazy\" decoding=\"async\" width=\"486\" height=\"583\" src=\"https:\/\/annualreport2023.edqm.eu\/wp-content\/uploads\/2024\/06\/Icon-08-OMCLs-Biologicals.png\" class=\"attachment-full size-full wp-image-787\" alt=\"\" srcset=\"https:\/\/annualreport2023.edqm.eu\/wp-content\/uploads\/2024\/06\/Icon-08-OMCLs-Biologicals.png 486w, https:\/\/annualreport2023.edqm.eu\/wp-content\/uploads\/2024\/06\/Icon-08-OMCLs-Biologicals-250x300.png 250w\" sizes=\"(max-width: 486px) 100vw, 486px\" \/>\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-40cd288c elementor-widget elementor-widget-counter\" data-id=\"40cd288c\" data-element_type=\"widget\" data-widget_type=\"counter.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-counter\">\n\t\t\t<div class=\"elementor-counter-title\">lots de vaccins contre le COVID-19<\/div>\t\t\t<div class=\"elementor-counter-number-wrapper\">\n\t\t\t\t<span class=\"elementor-counter-number-prefix\"><\/span>\n\t\t\t\t<span class=\"elementor-counter-number\" data-duration=\"1000\" data-to-value=\"320\" data-from-value=\"0\" data-delimiter=\",\">0<\/span>\n\t\t\t\t<span class=\"elementor-counter-number-suffix\"><\/span>\n\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<div class=\"elementor-element elementor-element-f1330bf elementor-widget elementor-widget-text-editor\" data-id=\"f1330bf\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>L\u2019assembl\u00e9e annuelle du r\u00e9seau OCABR pour les produits biologiques \u00e0 usage humain a principalement port\u00e9 sur les produits du sang, les vaccins et les probl\u00e8mes communs, et s\u2019est av\u00e9r\u00e9e l\u2019occasion de partager les expertises, d\u2019optimiser les ressources et de mettre au point des strat\u00e9gies afin de d\u00e9velopper l\u2019approche commune.<\/p><p class=\"translation-block\">Les activit\u00e9s prioritaires en 2023 comprenaient, notamment, le maintien de la lib\u00e9ration r\u00e9guli\u00e8re des lots, afin d\u2019assurer un approvisionnement constant du grand public en m\u00e9dicaments essentiels \u2013 tels que les vaccins p\u00e9diatriques et les facteurs de coagulation humains \u2013, et la pr\u00e9paration de la mise sur le march\u00e9 de nouveaux produits. Les OMCL ont \u00e9valu\u00e9 quelque 11 900 lots finaux de vaccins pour usage humain et de m\u00e9dicaments d\u00e9riv\u00e9s du sang humain, et ont contr\u00f4l\u00e9 l\u2019innocuit\u00e9 d\u2019environ 12 460 m\u00e9langes de plasma. Environ 320 lots de vaccins contre le COVID-19 ont \u00e9t\u00e9 lib\u00e9r\u00e9s en 2023, ce qui contraste avec les plus de 1 700 lots lib\u00e9r\u00e9s l\u2019ann\u00e9e pr\u00e9c\u00e9dente. Ces chiffres refl\u00e8tent la fin tant attendue de la pand\u00e9mie et de la crise sanitaire mondiale. Des membres du personnel de l\u2019EDQM et du r\u00e9seau OCABR ont cor\u00e9dig\u00e9 un article sur les contributions du r\u00e9seau au contr\u00f4le des vaccins contre le COVID-19 pendant la pand\u00e9mie. Publi\u00e9 en f\u00e9vrier dans la revue <em>npj Vaccines<\/em>, il d\u00e9crit les d\u00e9fis rencontr\u00e9s, les bons r\u00e9sultats obtenus et les enseignements \u00e0 tirer pour l\u2019avenir <a href=\"https:\/\/doi.org\/10.1038\/s41541-023-00617-x\" target=\"_blank\" rel=\"noopener\"><span style=\"text-decoration: underline\">(Milne et\u00a0al. 2023)<\/span><\/a>. La quantit\u00e9 de vaccins en cours de d\u00e9veloppement ne cessant de cro\u00eetre, les OMCL travaillent continuellement \u00e0 l\u2019\u00e9laboration et \u00e0 la r\u00e9vision de nombreux documents de recommandation et mettent en \u0153uvre de nouvelles m\u00e9thodes en pr\u00e9paration de la lib\u00e9ration des lots. La proc\u00e9dure OCABR permet de confirmer, de mani\u00e8re ind\u00e9pendante, que la qualit\u00e9 de ces produits r\u00e9pond aux crit\u00e8res \u00e9tablis avant qu\u2019ils ne parviennent aux personnes auxquelles ils seront administr\u00e9s.<\/p><p class=\"translation-block\">En vertu du principe des 3R, c\u2019est-\u00e0-dire l\u2019engagement \u00e0 r\u00e9duire, raffiner et remplacer l\u2019utilisation des animaux dans les essais de contr\u00f4le qualit\u00e9 dans le cadre de la lib\u00e9ration des lots, les OMCL ont pr\u00e9sent\u00e9 plusieurs initiatives men\u00e9es \u00e0 bien, notamment la mise en \u0153uvre des essais in vitro des vaccins contre l\u2019enc\u00e9phalite \u00e0 tiques, des exemples de contr\u00f4le des endotoxines par la m\u00e9thode du facteur C recombinant (rFC) et le passage \u00e0 une strat\u00e9gie multiplex pour le contr\u00f4le s\u00e9rologique de la dipht\u00e9rie (D), du t\u00e9tanos (T) et de la coqueluche acellulaire (Ca). Ces techniques permettent de r\u00e9duire significativement le nombre d\u2019animaux utilis\u00e9s. Les travaux en cours pour passer \u00e0 une approche de DTCa compl\u00e8tement <em>in vitro<\/em> sont suivis de pr\u00e8s par le r\u00e9seau, l\u2019objectif \u00e9tant de pouvoir la mettre en \u0153uvre \u00e0 l\u2019avenir.<\/p><p>En novembre, une formation sur la proc\u00e9dure OCABR pour les produits biologiques a \u00e9t\u00e9 organis\u00e9e, au format hybride, \u00e0 destination des novices en la mati\u00e8re. Elle a rencontr\u00e9 un grand succ\u00e8s : 44 personnes issues d\u2019OMCL, d\u2019ANC et de fabricants de l\u2019UE et du monde entier y ont assist\u00e9 sur place et 156 l\u2019ont suivie en ligne.<\/p><p><strong>Lib\u00e9ration des lots de m\u00e9dicaments immunologiques v\u00e9t\u00e9rinaires<\/strong><\/p><p>Le Comit\u00e9 consultatif du Veterinary Batch Release Network (VBRN) \u2013 le r\u00e9seau charg\u00e9 de la lib\u00e9ration des lots de m\u00e9dicaments v\u00e9t\u00e9rinaires \u2013 a tenu deux r\u00e9unions en 2023 afin de progresser sur des questions importantes et de pr\u00e9parer l\u2019assembl\u00e9e annuelle, qui s\u2019est d\u00e9roul\u00e9e en juin. Cette ann\u00e9e marquait le renouvellement du comit\u00e9, qui comprend d\u00e9sormais des repr\u00e9sentant\u00b7es de l\u2019Allemagne, de la Belgique, de la Pologne et de la R\u00e9publique slovaque.<\/p><p>Le recours \u00e0 des mod\u00e8les communs visant \u00e0 mieux coordonner les activit\u00e9s de surveillance apr\u00e8s commercialisation des produits s\u2019est poursuivi ; six OMCL ont communiqu\u00e9 des donn\u00e9es en 2023 au sujet de futurs plans et des activit\u00e9s de 2022.<\/p><p>Outre ses activit\u00e9s habituelles, qui incluent l\u2019\u00e9valuation officielle des protocoles de contr\u00f4le des lots (OBPR) et la proc\u00e9dure OCABR pour les produits inscrits sur la liste r\u00e9duite, le r\u00e9seau est rest\u00e9 vigilant et a coordonn\u00e9 une strat\u00e9gie de contr\u00f4le \u00e0 court terme en r\u00e9ponse \u00e0 un probl\u00e8me qualit\u00e9 sp\u00e9cifique pour un produit donn\u00e9, qui a \u00e9t\u00e9 signal\u00e9 lors de son assembl\u00e9e annuelle.<\/p><p class=\"translation-block\">Plusieurs OMCL impliqu\u00e9s dans la lib\u00e9ration des lots de m\u00e9dicaments immunologiques v\u00e9t\u00e9rinaires (MIV) ont \u00e9galement contribu\u00e9 aux efforts en mati\u00e8re de 3R en mettant en application des essais d\u2019activit\u00e9 <em>in vitro<\/em> pour le vaccin antirabique inactiv\u00e9 pour usage v\u00e9t\u00e9rinaire.<\/p><p>Le Comit\u00e9 consultatif a termin\u00e9 la mise \u00e0 jour des <em>guidelines<\/em> et des documents du r\u00e9seau afin de rester en phase avec la mise en \u0153uvre du nouveau r\u00e8glement (UE) n\u00ba 2019\/6 relatif aux m\u00e9dicaments v\u00e9t\u00e9rinaires, entr\u00e9 en vigueur le 28 janvier 2022.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<section class=\"elementor-section elementor-inner-section elementor-element elementor-element-9eabbd5 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"9eabbd5\" data-element_type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-50 elementor-inner-column elementor-element elementor-element-df6e569\" data-id=\"df6e569\" data-element_type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-47f4a40 elementor-widget elementor-widget-heading\" data-id=\"47f4a40\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h4 class=\"elementor-heading-title elementor-size-default\">Coop\u00e9ration internationale<\/h4>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-76d3321 elementor-widget elementor-widget-text-editor\" data-id=\"76d3321\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>Le r\u00e9seau OCABR pour les produits biologiques \u00e0 usage humain a poursuivi sa coop\u00e9ration mondiale par le biais des protocoles d\u2019entente conclus avec les autorit\u00e9s du Canada, du Royaume-Uni, d\u2019Australie et d\u2019Isra\u00ebl, ainsi qu\u2019avec la Taiwan Food and Drug Administration (TFDA). En novembre, \u00e0 l\u2019occasion de l\u2019atelier de recherche comparative des meilleures pratiques concernant le r\u00f4le des r\u00e9seaux dans la lib\u00e9ration des lots de vaccins, organis\u00e9 par l\u2019Autorit\u00e9 \u00e9gyptienne des m\u00e9dicaments au Caire, l\u2019EDQM a fait part de son exp\u00e9rience en la mati\u00e8re. L\u2019EDQM et les membres du r\u00e9seau OCABR de l\u2019UE ont \u00e9galement contribu\u00e9 aux activit\u00e9s du R\u00e9seau OMS-Laboratoires nationaux de contr\u00f4le pour les produits biologiques pr\u00e9qualifi\u00e9s par l\u2019OMS.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t<div class=\"elementor-column elementor-col-50 elementor-inner-column elementor-element elementor-element-1d5bd0c\" data-id=\"1d5bd0c\" data-element_type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-f508cda elementor-widget elementor-widget-heading\" data-id=\"f508cda\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h4 class=\"elementor-heading-title elementor-size-default\">Publications, bases de donn\u00e9es et site web<\/h4>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-d347e87 elementor-widget elementor-widget-text-editor\" data-id=\"d347e87\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>Fin 2023, la base de donn\u00e9es regroupant les \u00e9tudes sur les produits autoris\u00e9s selon la proc\u00e9dure de reconnaissance mutuelle (PRM) ou selon la proc\u00e9dure d\u00e9centralis\u00e9e (PDC) (cr\u00e9\u00e9e en 2007 dans le but de renforcer la coop\u00e9ration relative aux activit\u00e9s de planification, d\u2019\u00e9chantillonnage et de communication des r\u00e9sultats concernant les produits PRM\/PDC men\u00e9es au sein du r\u00e9seau OMCL) comptait plus de 17 800 enregistrements, auxquels avaient contribu\u00e9 37 OMCL. L\u2019acc\u00e8s \u00e0 cette base de donn\u00e9es est r\u00e9serv\u00e9 aux OMCL et aux Autorit\u00e9s de sant\u00e9.<\/p><p>Depuis mars 2020, des mod\u00e8les d\u2019\u00e9valuation des risques contenant \u00e9galement des recommandations relatives au contr\u00f4le des produits PRM\/PDC ont \u00e9t\u00e9 r\u00e9guli\u00e8rement transf\u00e9r\u00e9s dans cette base de donn\u00e9es, qui en comptait environ 2 200, \u00e0 la fin de l\u2019ann\u00e9e 2023.<\/p><p>Un nouveau <em>guideline<\/em> et 13 <em>guidelines<\/em> r\u00e9vis\u00e9s concernant la lib\u00e9ration des lots de vaccins pour usage humain, ainsi qu\u2019un <em>guideline<\/em> r\u00e9vis\u00e9 concernant les m\u00e9dicaments d\u00e9riv\u00e9s du sang et du plasma humains sont entr\u00e9s en vigueur.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-32556c1 elementor-section-stretched elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"32556c1\" data-element_type=\"section\" data-settings=\"{&quot;stretch_section&quot;:&quot;section-stretched&quot;}\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-50 elementor-top-column elementor-element elementor-element-32ab12c elementor-invisible\" data-id=\"32ab12c\" data-element_type=\"column\" data-settings=\"{&quot;animation&quot;:&quot;fadeInLeft&quot;}\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-2bd603c elementor-widget elementor-widget-button\" data-id=\"2bd603c\" data-element_type=\"widget\" data-widget_type=\"button.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<div class=\"elementor-button-wrapper\">\n\t\t\t\t\t<a class=\"elementor-button elementor-button-link elementor-size-sm\" href=\"https:\/\/annualreport2023.edqm.eu\/fr\/certification-of-suitability\/\">\n\t\t\t\t\t\t<span class=\"elementor-button-content-wrapper\">\n\t\t\t\t\t\t<span class=\"elementor-button-icon\">\n\t\t\t\t<svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-arrow-left\" viewbox=\"0 0 448 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M257.5 445.1l-22.2 22.2c-9.4 9.4-24.6 9.4-33.9 0L7 273c-9.4-9.4-9.4-24.6 0-33.9L201.4 44.7c9.4-9.4 24.6-9.4 33.9 0l22.2 22.2c9.5 9.5 9.3 25-.4 34.3L136.6 216H424c13.3 0 24 10.7 24 24v32c0 13.3-10.7 24-24 24H136.6l120.5 114.8c9.8 9.3 10 24.8.4 34.3z\"><\/path><\/svg>\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t<span class=\"elementor-button-text\">Page pr\u00e9c\u00e9dente<\/span>\n\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/a>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t<div class=\"elementor-column elementor-col-50 elementor-top-column elementor-element elementor-element-80f43ff elementor-invisible\" data-id=\"80f43ff\" data-element_type=\"column\" data-settings=\"{&quot;animation&quot;:&quot;fadeInRight&quot;,&quot;animation_mobile&quot;:&quot;fadeInLeft&quot;}\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-870764a elementor-align-right elementor-mobile-align-left elementor-widget elementor-widget-button\" data-id=\"870764a\" data-element_type=\"widget\" data-widget_type=\"button.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<div class=\"elementor-button-wrapper\">\n\t\t\t\t\t<a class=\"elementor-button elementor-button-link elementor-size-sm\" href=\"https:\/\/annualreport2023.edqm.eu\/fr\/response-to-nitrosamine-contamination\/\">\n\t\t\t\t\t\t<span class=\"elementor-button-content-wrapper\">\n\t\t\t\t\t\t<span class=\"elementor-button-icon\">\n\t\t\t\t<svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-arrow-right\" viewbox=\"0 0 448 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M190.5 66.9l22.2-22.2c9.4-9.4 24.6-9.4 33.9 0L441 239c9.4 9.4 9.4 24.6 0 33.9L246.6 467.3c-9.4 9.4-24.6 9.4-33.9 0l-22.2-22.2c-9.5-9.5-9.3-25 .4-34.3L311.4 296H24c-13.3 0-24-10.7-24-24v-32c0-13.3 10.7-24 24-24h287.4L190.9 101.2c-9.8-9.3-10-24.8-.4-34.3z\"><\/path><\/svg>\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t<span class=\"elementor-button-text\">Page suivante<\/span>\n\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/a>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<\/div>","protected":false},"excerpt":{"rendered":"<p>Quality &#038; use of medicines The European Network of Official Medicines Control Laboratories The OMCL Network brings together official laboratories based in 34 European member states and in seven non-European countries. Together, they ensure the quality of medicines on the market and prevent substandard and falsified medicinal products from reaching their final users. This safeguards [&hellip;]<\/p>","protected":false},"author":1,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"ocean_post_layout":"","ocean_both_sidebars_style":"","ocean_both_sidebars_content_width":0,"ocean_both_sidebars_sidebars_width":0,"ocean_sidebar":"","ocean_second_sidebar":"","ocean_disable_margins":"enable","ocean_add_body_class":"","ocean_shortcode_before_top_bar":"","ocean_shortcode_after_top_bar":"","ocean_shortcode_before_header":"","ocean_shortcode_after_header":"","ocean_has_shortcode":"","ocean_shortcode_after_title":"","ocean_shortcode_before_footer_widgets":"","ocean_shortcode_after_footer_widgets":"","ocean_shortcode_before_footer_bottom":"","ocean_shortcode_after_footer_bottom":"","ocean_display_top_bar":"default","ocean_display_header":"default","ocean_header_style":"","ocean_center_header_left_menu":"","ocean_custom_header_template":"","ocean_custom_logo":0,"ocean_custom_retina_logo":0,"ocean_custom_logo_max_width":0,"ocean_custom_logo_tablet_max_width":0,"ocean_custom_logo_mobile_max_width":0,"ocean_custom_logo_max_height":0,"ocean_custom_logo_tablet_max_height":0,"ocean_custom_logo_mobile_max_height":0,"ocean_header_custom_menu":"","ocean_menu_typo_font_family":"","ocean_menu_typo_font_subset":"","ocean_menu_typo_font_size":0,"ocean_menu_typo_font_size_tablet":0,"ocean_menu_typo_font_size_mobile":0,"ocean_menu_typo_font_size_unit":"px","ocean_menu_typo_font_weight":"","ocean_menu_typo_font_weight_tablet":"","ocean_menu_typo_font_weight_mobile":"","ocean_menu_typo_transform":"","ocean_menu_typo_transform_tablet":"","ocean_menu_typo_transform_mobile":"","ocean_menu_typo_line_height":0,"ocean_menu_typo_line_height_tablet":0,"ocean_menu_typo_line_height_mobile":0,"ocean_menu_typo_line_height_unit":"","ocean_menu_typo_spacing":0,"ocean_menu_typo_spacing_tablet":0,"ocean_menu_typo_spacing_mobile":0,"ocean_menu_typo_spacing_unit":"","ocean_menu_link_color":"","ocean_menu_link_color_hover":"","ocean_menu_link_color_active":"","ocean_menu_link_background":"","ocean_menu_link_hover_background":"","ocean_menu_link_active_background":"","ocean_menu_social_links_bg":"","ocean_menu_social_hover_links_bg":"","ocean_menu_social_links_color":"","ocean_menu_social_hover_links_color":"","ocean_disable_title":"default","ocean_disable_heading":"default","ocean_post_title":"","ocean_post_subheading":"","ocean_post_title_style":"","ocean_post_title_background_color":"","ocean_post_title_background":0,"ocean_post_title_bg_image_position":"","ocean_post_title_bg_image_attachment":"","ocean_post_title_bg_image_repeat":"","ocean_post_title_bg_image_size":"","ocean_post_title_height":0,"ocean_post_title_bg_overlay":0.5,"ocean_post_title_bg_overlay_color":"","ocean_disable_breadcrumbs":"default","ocean_breadcrumbs_color":"","ocean_breadcrumbs_separator_color":"","ocean_breadcrumbs_links_color":"","ocean_breadcrumbs_links_hover_color":"","ocean_display_footer_widgets":"default","ocean_display_footer_bottom":"default","ocean_custom_footer_template":"","footnotes":""},"class_list":["post-383","page","type-page","status-publish","hentry","entry"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v25.5 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>The European Network of Official Medicines Control Laboratories | Quality &amp; use of medicines - EDQM<\/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:\/\/annualreport2023.edqm.eu\/fr\/european-network-of-official-medicines-control-laboratories\/\" \/>\n<meta property=\"og:locale\" content=\"fr_FR\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"The European Network of Official Medicines Control Laboratories | Quality &amp; use of medicines - EDQM\" \/>\n<meta property=\"og:description\" content=\"Quality &#038; use of medicines The European Network of Official Medicines Control Laboratories The OMCL Network brings together official laboratories based in 34 European member states and in seven non-European countries. 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