{"id":345,"date":"2024-04-24T15:45:43","date_gmt":"2024-04-24T15:45:43","guid":{"rendered":"http:\/\/annualreport-2025.guerillainteractive.co.uk\/?page_id=345"},"modified":"2025-07-24T13:08:43","modified_gmt":"2025-07-24T13:08:43","slug":"pharmacopee-europeenne","status":"publish","type":"page","link":"https:\/\/annualreport-2025.guerillainteractive.co.uk\/fr\/pharmacopee-europeenne\/","title":{"rendered":"Pharmacop\u00e9e Europ\u00e9enne"},"content":{"rendered":"<div data-elementor-type=\"wp-page\" data-elementor-id=\"345\" class=\"elementor elementor-345\" data-elementor-post-type=\"page\">\n\t\t\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-5ad83a1 elementor-section-height-min-height elementor-section-stretched elementor-section-boxed elementor-section-height-default elementor-section-items-middle elementor-invisible\" data-id=\"5ad83a1\" data-element_type=\"section\" data-e-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;}\" data-no-translation=\"\">\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-b9d87e8\" data-id=\"b9d87e8\" data-element_type=\"column\" data-e-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-9ca0d2f elementor-widget elementor-widget-heading\" data-id=\"9ca0d2f\" data-element_type=\"widget\" data-e-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\">Qualit\u00e9 et utilisation des m\u00e9dicaments<\/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-1c94607 elementor-section-stretched animated-slow elementor-section-boxed elementor-section-height-default elementor-section-height-default elementor-invisible\" data-id=\"1c94607\" data-element_type=\"section\" data-e-type=\"section\" data-settings=\"{&quot;stretch_section&quot;:&quot;section-stretched&quot;,&quot;animation&quot;:&quot;fadeInUp&quot;,&quot;background_background&quot;:&quot;classic&quot;,&quot;animation_mobile&quot;:&quot;fadeIn&quot;}\" data-no-translation=\"\">\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-165a191\" data-id=\"165a191\" data-element_type=\"column\" data-e-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-c5fc619 elementor-widget elementor-widget-heading\" data-id=\"c5fc619\" data-element_type=\"widget\" data-e-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\">Liens utiles<\/h4>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-108e79c elementor-widget__width-auto elementor-widget elementor-widget-button\" data-id=\"108e79c\" data-element_type=\"widget\" data-e-type=\"widget\" data-no-translation=\"\" 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=\"#europeanpharmacopoeia\">\n\t\t\t\t\t\t<span class=\"elementor-button-content-wrapper\">\n\t\t\t\t\t\t\t\t\t<span class=\"elementor-button-text\">Pharmacop\u00e9e Europ\u00e9enne<\/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<div class=\"elementor-element elementor-element-a8dfc71 elementor-widget__width-auto elementor-widget elementor-widget-button\" data-id=\"a8dfc71\" data-element_type=\"widget\" data-e-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:\/\/annualreport-2025.guerillainteractive.co.uk\/fr\/etalons-de-reference\/\">\n\t\t\t\t\t\t<span class=\"elementor-button-content-wrapper\">\n\t\t\t\t\t\t\t\t\t<span class=\"elementor-button-text\">\u00c9talons de r\u00e9f\u00e9rence<\/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<div class=\"elementor-element elementor-element-a8f5202 elementor-widget__width-auto elementor-widget elementor-widget-button\" data-id=\"a8f5202\" data-element_type=\"widget\" data-e-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:\/\/annualreport-2025.guerillainteractive.co.uk\/fr\/certification-de-conformite\/\">\n\t\t\t\t\t\t<span class=\"elementor-button-content-wrapper\">\n\t\t\t\t\t\t\t\t\t<span class=\"elementor-button-text\">Certification de conformit\u00e9 aux monographies de la Ph. Eur.<\/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<div class=\"elementor-element elementor-element-8204e90 elementor-widget__width-auto elementor-widget elementor-widget-button\" data-id=\"8204e90\" data-element_type=\"widget\" data-e-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:\/\/annualreport-2025.guerillainteractive.co.uk\/fr\/reseau-europeen-des-laboratoires-officiels-de-controle-des-medicaments\/\">\n\t\t\t\t\t\t<span class=\"elementor-button-content-wrapper\">\n\t\t\t\t\t\t\t\t\t<span class=\"elementor-button-text\">R\u00e9seau europ\u00e9en des laboratoires officiels de contr\u00f4le des m\u00e9dicaments<\/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<div class=\"elementor-element elementor-element-50e292f elementor-widget__width-auto elementor-widget elementor-widget-button\" data-id=\"50e292f\" data-element_type=\"widget\" data-e-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:\/\/annualreport-2025.guerillainteractive.co.uk\/fr\/activites-antifalsification\/\">\n\t\t\t\t\t\t<span class=\"elementor-button-content-wrapper\">\n\t\t\t\t\t\t\t\t\t<span class=\"elementor-button-text\">Activit\u00e9s antifalsification<\/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<div class=\"elementor-element elementor-element-1c9e259 elementor-widget__width-auto elementor-widget elementor-widget-button\" data-id=\"1c9e259\" data-element_type=\"widget\" data-e-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:\/\/annualreport-2025.guerillainteractive.co.uk\/fr\/produits-et-suivi-pharmaceutiques\/\">\n\t\t\t\t\t\t<span class=\"elementor-button-content-wrapper\">\n\t\t\t\t\t\t\t\t\t<span class=\"elementor-button-text\">Produits et suivi pharmaceutiques<\/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<div class=\"elementor-element elementor-element-4b26b80 elementor-widget__width-auto elementor-widget elementor-widget-button\" data-id=\"4b26b80\" data-element_type=\"widget\" data-e-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:\/\/annualreport-2025.guerillainteractive.co.uk\/fr\/formulaire-pediatrique-europeen\/\">\n\t\t\t\t\t\t<span class=\"elementor-button-content-wrapper\">\n\t\t\t\t\t\t\t\t\t<span class=\"elementor-button-text\">Formulaire p\u00e9diatrique europ\u00e9en<\/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<section class=\"elementor-section elementor-top-section elementor-element elementor-element-2829404 elementor-section-stretched animated-slow elementor-section-boxed elementor-section-height-default elementor-section-height-default elementor-invisible\" data-id=\"2829404\" data-element_type=\"section\" data-e-type=\"section\" data-settings=\"{&quot;stretch_section&quot;:&quot;section-stretched&quot;,&quot;animation&quot;:&quot;fadeIn&quot;}\" data-no-translation=\"\">\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-ca64f6b\" data-id=\"ca64f6b\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<section class=\"elementor-section elementor-inner-section elementor-element elementor-element-1705a7e elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"1705a7e\" data-element_type=\"section\" data-e-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-100 elementor-inner-column elementor-element elementor-element-7735cb5\" data-id=\"7735cb5\" data-element_type=\"column\" data-e-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-a8ae1f9 elementor-widget elementor-widget-heading\" data-id=\"a8ae1f9\" data-element_type=\"widget\" data-e-type=\"widget\" data-no-translation=\"\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<style>.elementor-element-a8ae1f9{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-343cc7d elementor-widget elementor-widget-text-editor\" data-id=\"343cc7d\" data-element_type=\"widget\" data-e-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>La Pharmacop\u00e9e Europ\u00e9enne (Ph.\u00a0Eur.) est la pierre angulaire du contr\u00f4le qualit\u00e9 des m\u00e9dicaments dans les 39\u00a0\u00c9tats membres ayant ratifi\u00e9 la Convention relative \u00e0 l\u2019\u00e9laboration d\u2019une Pharmacop\u00e9e europ\u00e9enne. En \u00e9laborant des normes qualit\u00e9 harmonis\u00e9es, elle joue un r\u00f4le essentiel dans la protection de la sant\u00e9 publique. En effet, elle fournit ainsi un cadre juridique et scientifique garantissant que les m\u00e9dicaments et leurs composants r\u00e9pondent \u00e0 des exigences qualit\u00e9, depuis leur d\u00e9veloppement jusqu\u2019\u00e0 leur production et leur mise sur le march\u00e9. Les normes qualit\u00e9 de la Ph.\u00a0Eur. sont juridiquement contraignantes pour tous les fabricants qui souhaitent commercialiser leurs produits dans ses \u00c9tats membres. \u00c0 la faveur de l\u2019\u00e9volution du paysage mondial de la production des m\u00e9dicaments, la Ph.\u00a0Eur. est d\u00e9sormais reconnue bien au-del\u00e0 des fronti\u00e8res de l\u2019Europe. Les normes qu\u2019elle \u00e9labore contribuent au d\u00e9veloppement de crit\u00e8res internationaux pour \u00e9valuer la qualit\u00e9 des m\u00e9dicaments. Elles favorisent ainsi l\u2019harmonisation des exigences qualit\u00e9 dans le monde entier et, par cons\u00e9quent, l\u2019utilisation sans danger et efficace des m\u00e9dicaments \u00e0 l\u2019\u00e9chelle plan\u00e9taire.<\/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-0f0327d elementor-section-stretched animated-slow elementor-section-boxed elementor-section-height-default elementor-section-height-default elementor-invisible\" data-id=\"0f0327d\" data-element_type=\"section\" data-e-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;}\" data-no-translation=\"\">\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-9d99159\" data-id=\"9d99159\" data-element_type=\"column\" data-e-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-180e251 elementor-widget elementor-widget-heading\" data-id=\"180e251\" data-element_type=\"widget\" data-e-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\">Une ann\u00e9e riche en nouveaut\u00e9s et innovations<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-70bdc7e elementor-widget elementor-widget-text-editor\" data-id=\"70bdc7e\" data-element_type=\"widget\" data-e-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>Au cours de l\u2019ann\u00e9e\u00a02024, 202\u00a0textes (nouveaux et r\u00e9vis\u00e9s) ont \u00e9t\u00e9 publi\u00e9s pour enqu\u00eate publique, dans les num\u00e9ros\u00a036.1 \u00e0 36.4 de <span style=\"color: #ffffff;\"><a style=\"color: #ffffff;\" href=\"https:\/\/pharmeuropa.edqm.eu\/home\" target=\"_blank\" rel=\"noopener\"><em>Pharmeuropa<\/em><\/a><\/span> (la plateforme de commentaires en ligne de la Ph.\u00a0Eur.). Au total, 28\u00a0nouvelles monographies, 11\u00a0nouveaux chapitres g\u00e9n\u00e9raux et 230\u00a0textes r\u00e9vis\u00e9s ont \u00e9t\u00e9 adopt\u00e9s lors des trois sessions de la Commission europ\u00e9enne de Pharmacop\u00e9e (EPC), organis\u00e9es en mars, juin et novembre. En offrant son temps et ses comp\u00e9tences techniques, la communaut\u00e9 mondiale d\u2019expert\u00b7es b\u00e9n\u00e9voles de la Ph.\u00a0Eur. poursuit la production de contenus d\u2019une grande richesse dans des domaines vari\u00e9s, comme soulign\u00e9 ci-apr\u00e8s. Ces textes\u00a0\u2013 nouveaux ou r\u00e9vis\u00e9s\u00a0\u2013 int\u00e8grent des proc\u00e9dures analytiques d\u00e9velopp\u00e9es r\u00e9cemment et fournissent des normes qualit\u00e9, fond\u00e9es sur la science et \u00e9tay\u00e9es par des donn\u00e9es, qui couvrent des produits pr\u00e9sentant un grand int\u00e9r\u00eat sur le march\u00e9 et des domaines \u00e9mergents. Ils contribuent ainsi \u00e0 la protection de la sant\u00e9 publique dans les 39\u00a0\u00c9tats membres de la Ph.\u00a0Eur. et dans les 130\u00a0pays o\u00f9 ils sont appliqu\u00e9s. En outre, 156\u00a0textes portant sur d\u2019autres sujets d\u2019int\u00e9r\u00eat ont \u00e9t\u00e9 inscrits au programme de travail.<\/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-db7489b elementor-section-stretched animated-slow elementor-section-boxed elementor-section-height-default elementor-section-height-default elementor-invisible\" data-id=\"db7489b\" data-element_type=\"section\" data-e-type=\"section\" data-settings=\"{&quot;stretch_section&quot;:&quot;section-stretched&quot;,&quot;animation&quot;:&quot;fadeIn&quot;}\" data-no-translation=\"\">\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-fda4fe4\" data-id=\"fda4fe4\" data-element_type=\"column\" data-e-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-5a92fef elementor-widget elementor-widget-heading\" data-id=\"5a92fef\" data-element_type=\"widget\" data-e-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\">Nos expert\u00b7es : une communaut\u00e9 scientifique internationale dynamique<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-ad6b781 elementor-widget elementor-widget-text-editor\" data-id=\"ad6b781\" data-element_type=\"widget\" data-e-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>Les travaux de la Ph.\u00a0Eur. sont pilot\u00e9s par une communaut\u00e9 d\u2019expertes et d\u2019experts internationale dynamique. Ce r\u00e9seau r\u00e9unit des professionnel\u00b7les provenant d\u2019Autorit\u00e9s nationales (Autorit\u00e9s de pharmacop\u00e9e, laboratoires officiels de contr\u00f4le des m\u00e9dicaments, autorit\u00e9s d\u2019enregistrement et corps d\u2019inspection, par exemple), du secteur priv\u00e9 (industries pharmaceutique et chimique), du milieu universitaire, d\u2019organismes de recherche et d\u2019autres secteurs d\u2019activit\u00e9. Hautement qualifi\u00e9es, ces personnes partagent leur expertise et leurs exp\u00e9riences au sein des plus de 60\u00a0groupes d\u2019expert\u00b7es et groupes de travail aupr\u00e8s desquels elles sont nomm\u00e9es pour trois ans par l\u2019EPC. En\u00a02024, pr\u00e8s d\u2019un millier d\u2019expert\u00b7es ont continu\u00e9 \u00e0 consacrer leur temps et leur \u00e9nergie \u00e0 l\u2019\u00e9laboration des normes publiques de la Ph.\u00a0Eur. V\u00e9ritable pilier de la Ph.\u00a0Eur., cette communaut\u00e9 assure le lien essentiel entre travaux exp\u00e9rimentaux et normes documentaires.<\/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-8fdbb03 elementor-section-stretched animated-slow elementor-section-boxed elementor-section-height-default elementor-section-height-default elementor-invisible\" data-id=\"8fdbb03\" data-element_type=\"section\" data-e-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;}\" data-no-translation=\"\">\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-4296407\" data-id=\"4296407\" data-element_type=\"column\" data-e-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-130111b elementor-widget elementor-widget-heading\" data-id=\"130111b\" data-element_type=\"widget\" data-e-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\">Accomplissements majeurs dans le domaine des 3R<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-e4eedb6 elementor-widget elementor-widget-text-editor\" data-id=\"e4eedb6\" data-element_type=\"widget\" data-e-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>Depuis l\u2019adoption de la <a href=\"https:\/\/www.coe.int\/fr\/web\/conventions\/full-list?module=treaty-detail&amp;treatynum=123\" target=\"_blank\" rel=\"noopener\">Convention europ\u00e9enne sur la protection des animaux vert\u00e9br\u00e9s utilis\u00e9s \u00e0 des fins exp\u00e9rimentales ou \u00e0 d\u2019autres fins scientifiques<\/a> (Conseil de l\u2019Europe, STE n\u00ba\u00a0123) en\u00a01986, l\u2019EPC et ses expert\u00b7es veillent \u00e0 proposer un programme de travail visant \u00e0 remplacer, r\u00e9duire et raffiner l\u2019utilisation des animaux \u00e0 des fins exp\u00e9rimentales (principe des 3R). \u00c0 l\u2019\u00e9chelle de l\u2019UE, la <a href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2010\/63\/oj\/eng?eliuri=eli%3Adir%3A2010%3A63%3Aoj&amp;locale=fr\" target=\"_blank\" rel=\"noopener\">Directive\u00a02010\/63\/UE relative \u00e0 la protection des animaux utilis\u00e9s \u00e0 des fins scientifiques d\u00e9conseille fortement l\u2019utilisation d\u2019animaux pour tester des m\u00e9dicaments<\/a>.<\/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-4da5097 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"4da5097\" data-element_type=\"section\" data-e-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-769857b\" data-id=\"769857b\" data-element_type=\"column\" data-e-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-5fca32c elementor-widget elementor-widget-heading\" data-id=\"5fca32c\" data-element_type=\"widget\" data-e-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\">Suppression de l\u2019essai des pyrog\u00e8nes sur lapin<\/h4>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-bab0252 elementor-widget elementor-widget-text-editor\" data-id=\"bab0252\" data-element_type=\"widget\" data-e-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>Dans une d\u00e9cision historique du point de vue du bien-\u00eatre animal comme de celui de la science, l\u2019EPC a d\u00e9cid\u00e9 de supprimer l\u2019essai des pyrog\u00e8nes sur lapin de ses monographies lors de sa 179<sup>e<\/sup>\u00a0session (juin\u00a02024), puis le chapitre correspondant lors de sa 180<sup>e<\/sup>\u00a0session (novembre\u00a02024).<\/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-080ddbd\" data-id=\"080ddbd\" data-element_type=\"column\" data-e-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-c48e9ee elementor-widget elementor-widget-heading\" data-id=\"c48e9ee\" data-element_type=\"widget\" data-e-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\">Fin des essais de d\u00e9tection de l\u2019histamine et des substances hypotensives pratiqu\u00e9s sur des animaux<\/h4>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-b35ae6f elementor-widget elementor-widget-text-editor\" data-id=\"b35ae6f\" data-element_type=\"widget\" data-e-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>Lors de sa 180<sup>e<\/sup>\u00a0session (novembre\u00a02024), l\u2019EPC a d\u00e9cid\u00e9 de supprimer de la Ph.\u00a0Eur. les essais de d\u00e9tection de l\u2019histamine et des substances hypotensives pratiqu\u00e9s sur animaux. Cette d\u00e9cision met fin \u00e0 l\u2019utilisation des animaux dans les essais d\u2019innocuit\u00e9 g\u00e9n\u00e9rale.<\/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-bf4ec06 elementor-section-stretched animated-slow elementor-section-boxed elementor-section-height-default elementor-section-height-default elementor-invisible\" data-id=\"bf4ec06\" data-element_type=\"section\" data-e-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;}\" data-no-translation=\"\">\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-874b993\" data-id=\"874b993\" data-element_type=\"column\" data-e-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-9652635 elementor-widget elementor-widget-heading\" data-id=\"9652635\" data-element_type=\"widget\" data-e-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\">\u00c0 noter \u00e9galement<\/h3>\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-6eafd4f elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"6eafd4f\" data-element_type=\"section\" data-e-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-8a9800e\" data-id=\"8a9800e\" data-element_type=\"column\" data-e-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-2ee5439 elementor-widget elementor-widget-heading\" data-id=\"2ee5439\" data-element_type=\"widget\" data-e-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\">\u00c9l\u00e9ments extractibles dans les plastiques pour usage pharmaceutique<\/h4>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-fe6506b elementor-widget elementor-widget-text-editor\" data-id=\"fe6506b\" data-element_type=\"widget\" data-e-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\u2019EPC a adopt\u00e9 un nouveau chapitre g\u00e9n\u00e9ral sur les <em>\u00c9l\u00e9ments extractibles dans les mati\u00e8res plastiques pour usage pharmaceutique (2.4.35).<\/em> Il d\u00e9finit les exigences relatives au contr\u00f4le des \u00e9l\u00e9ments extractibles, qui permettent de garantir l\u2019innocuit\u00e9 et la qualit\u00e9 des produits pharmaceutiques.<\/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-f403284\" data-id=\"f403284\" data-element_type=\"column\" data-e-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-60bce0d elementor-widget elementor-widget-heading\" data-id=\"60bce0d\" data-element_type=\"widget\" data-e-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\">M\u00e9dicaments utilis\u00e9s en phagoth\u00e9rapie<\/h4>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-8736662 elementor-widget elementor-widget-text-editor\" data-id=\"8736662\" data-element_type=\"widget\" data-e-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>Dans le domaine des produits biologiques, l\u2019EPC a adopt\u00e9 un nouveau chapitre g\u00e9n\u00e9ral sur les <em>M\u00e9dicaments utilis\u00e9s en phagoth\u00e9rapie (5.31).<\/em> Il fournit des recommandations compl\u00e8tes concernant les exigences qualit\u00e9 applicables aux produits de phagoth\u00e9rapie, qui suscitent un int\u00e9r\u00eat croissant en tant que traitements potentiels des infections bact\u00e9riennes antibior\u00e9sistantes.<\/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-inner-section elementor-element elementor-element-21b6938 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"21b6938\" data-element_type=\"section\" data-e-type=\"section\" data-no-translation=\"\">\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-inner-column elementor-element elementor-element-b6440e2\" data-id=\"b6440e2\" data-element_type=\"column\" data-e-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-444147a elementor-widget elementor-widget-heading\" data-id=\"444147a\" data-element_type=\"widget\" data-e-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\">M\u00e9dicaments de th\u00e9rapie g\u00e9nique<\/h4>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-e055442 elementor-widget elementor-widget-text-editor\" data-id=\"e055442\" data-element_type=\"widget\" data-e-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>Avec l\u2019introduction de la monographie g\u00e9n\u00e9rale sur les <em>M\u00e9dicaments de th\u00e9rapie g\u00e9nique pour usage humain (3186)<\/em>, l\u2019EPC a adopt\u00e9 une nouvelle approche de la th\u00e9rapie g\u00e9nique, en se concentrant sur la qualit\u00e9 et l\u2019innocuit\u00e9 de ces m\u00e9dicaments. L\u2019objectif est de fournir des recommandations claires et compl\u00e8tes pour le d\u00e9veloppement et la production de ces th\u00e9rapies innovantes.<\/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-b5392b9 elementor-section-stretched animated-slow elementor-section-boxed elementor-section-height-default elementor-section-height-default elementor-invisible\" data-id=\"b5392b9\" data-element_type=\"section\" data-e-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;}\" data-no-translation=\"\">\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-b52d2a2\" data-id=\"b52d2a2\" data-element_type=\"column\" data-e-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-ceceed9 elementor-widget elementor-widget-heading\" data-id=\"ceceed9\" data-element_type=\"widget\" data-e-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\">Strat\u00e9gie de la Ph. Eur. relative \u00e0 la contamination par les nitrosamines<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-cc559b6 elementor-widget elementor-widget-text-editor\" data-id=\"cc559b6\" data-element_type=\"widget\" data-e-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>D\u00e9but\u00a02024, l\u2019EPC a mis au point une nouvelle strat\u00e9gie pour r\u00e9pondre \u00e0 la probl\u00e9matique des impuret\u00e9s <em>N<\/em>-nitrosamine dans les monographies de la Ph.\u00a0Eur. L\u2019objectif est de clarifier les exigences de d\u00e9tection et de contr\u00f4le de ces impuret\u00e9s potentiellement nocives, afin de garantir l\u2019innocuit\u00e9 et la qualit\u00e9 des m\u00e9dicaments. Cette strat\u00e9gie est d\u00e9taill\u00e9e sur la <a href=\"https:\/\/www.edqm.eu\/fr\/n-nitrosamine-contamination-in-brief\" target=\"_blank\" rel=\"noopener\">page web de l\u2019EDQM consacr\u00e9e aux nitrosamines<\/a>.<\/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-09bda3c elementor-section-stretched animated-slow elementor-section-boxed elementor-section-height-default elementor-section-height-default elementor-invisible\" data-id=\"09bda3c\" data-element_type=\"section\" data-e-type=\"section\" data-settings=\"{&quot;stretch_section&quot;:&quot;section-stretched&quot;,&quot;animation&quot;:&quot;fadeIn&quot;}\" data-no-translation=\"\">\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-7d45673\" data-id=\"7d45673\" data-element_type=\"column\" data-e-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-4881547 no-margin elementor-widget elementor-widget-heading\" data-id=\"4881547\" data-element_type=\"widget\" data-e-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\">Programmes conjoints<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-0eaf407 elementor-widget elementor-widget-heading\" data-id=\"0eaf407\" data-element_type=\"widget\" data-e-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 standardisation biologique<\/h4>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-0c861a9 elementor-widget elementor-widget-text-editor\" data-id=\"0c861a9\" data-element_type=\"widget\" data-e-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 programme de standardisation biologique (BSP) est une initiative conjointe de l\u2019UE et du Conseil de l\u2019Europe, financ\u00e9e en partie par l\u2019UE. Il a pour mission d\u2019\u00e9tablir des \u00e9talons de r\u00e9f\u00e9rence (ER) destin\u00e9s \u00e0 l\u2019analyse de produits biologiques, et de d\u00e9velopper et valider de nouvelles proc\u00e9dures analytiques pour le contr\u00f4le qualit\u00e9 de ces derniers, notamment des m\u00e9thodes alternatives aux essais de laboratoire sur animaux, selon le principe des 3R.<\/p><p>En\u00a02024, dans le cadre de ce programme, 25\u00a0projets ont \u00e9t\u00e9 men\u00e9s dans diff\u00e9rents domaines, des vaccins pour usage humain ou v\u00e9t\u00e9rinaire aux produits d\u00e9riv\u00e9s du plasma, en passant par les produits biotechnologiques. Trois projets relatifs \u00e0 l\u2019\u00e9tablissement d\u2019\u00e9talons de r\u00e9f\u00e9rence sont arriv\u00e9s \u00e0 leur terme\u00a0: l\u2019un menant \u00e0 l\u2019\u00e9tablissement d\u2019un nouvel ER et les deux autres \u00e0 celui de pr\u00e9parations biologiques de r\u00e9f\u00e9rence (PBR)\/substances chimiques de r\u00e9f\u00e9rence (SCR) de remplacement (voir <a href=\"https:\/\/annualreport-2025.guerillainteractive.co.uk\/fr\/etalons-de-reference\/\"><em>\u00c9talons de r\u00e9f\u00e9rence<\/em><\/a>).<\/p><p>L\u2019EDQM a men\u00e9 15\u00a0autres projets portant sur l\u2019\u00e9tablissement de lots de remplacement d\u2019ER existants et trois portant sur l\u2019\u00e9tablissement de nouveaux ER pour des produits biologiques.<\/p><p>Trois projets en cours sont ax\u00e9s sur le d\u00e9veloppement de nouvelles m\u00e9thodes de pharmacop\u00e9e. Ils concernent tous l\u2019application du principe des\u00a03R dans le domaine du contr\u00f4le qualit\u00e9 des produits biologiques.<\/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-f69c21e elementor-widget elementor-widget-image\" data-id=\"f69c21e\" data-element_type=\"widget\" data-e-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=\"1636\" height=\"388\" src=\"https:\/\/annualreport-2025.guerillainteractive.co.uk\/wp-content\/uploads\/2024\/06\/Funded-EU-and-COE-Implemented-COE-quadri-fr.png\" class=\"attachment-full size-full wp-image-939\" alt=\"\" srcset=\"https:\/\/annualreport-2025.guerillainteractive.co.uk\/wp-content\/uploads\/2024\/06\/Funded-EU-and-COE-Implemented-COE-quadri-fr.png 1636w, https:\/\/annualreport-2025.guerillainteractive.co.uk\/wp-content\/uploads\/2024\/06\/Funded-EU-and-COE-Implemented-COE-quadri-fr-300x71.png 300w, https:\/\/annualreport-2025.guerillainteractive.co.uk\/wp-content\/uploads\/2024\/06\/Funded-EU-and-COE-Implemented-COE-quadri-fr-1024x243.png 1024w, https:\/\/annualreport-2025.guerillainteractive.co.uk\/wp-content\/uploads\/2024\/06\/Funded-EU-and-COE-Implemented-COE-quadri-fr-768x182.png 768w, https:\/\/annualreport-2025.guerillainteractive.co.uk\/wp-content\/uploads\/2024\/06\/Funded-EU-and-COE-Implemented-COE-quadri-fr-1536x364.png 1536w, https:\/\/annualreport-2025.guerillainteractive.co.uk\/wp-content\/uploads\/2024\/06\/Funded-EU-and-COE-Implemented-COE-quadri-fr-18x4.png 18w\" sizes=\"(max-width: 1636px) 100vw, 1636px\" \/>\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<section class=\"elementor-section elementor-top-section elementor-element elementor-element-63a5ac3 elementor-section-stretched animated-slow elementor-section-boxed elementor-section-height-default elementor-section-height-default elementor-invisible\" data-id=\"63a5ac3\" data-element_type=\"section\" data-e-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;}\" data-no-translation=\"\">\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-16b9566\" data-id=\"16b9566\" data-element_type=\"column\" data-e-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-ab86e9b elementor-widget elementor-widget-heading\" data-id=\"ab86e9b\" data-element_type=\"widget\" data-e-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\">Initiatives de coop\u00e9ration et d\u2019harmonisation internationales<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-b70d2a1 elementor-widget elementor-widget-heading\" data-id=\"b70d2a1\" data-element_type=\"widget\" data-e-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\">Groupe de discussion des pharmacop\u00e9es<\/h4>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-e384def elementor-widget elementor-widget-text-editor\" data-id=\"e384def\" data-element_type=\"widget\" data-e-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>Depuis l\u2019int\u00e9gration en octobre\u00a02023 de la Commission indienne de Pharmacop\u00e9e (IPC), qui a rejoint la Ph.\u00a0Eur., la Pharmacop\u00e9e japonaise (JP) et la Pharmacop\u00e9e des \u00c9tats-Unis (USP) en tant que quatri\u00e8me membre du Groupe de discussion des pharmacop\u00e9es (GDP), le groupe a r\u00e9alis\u00e9 des progr\u00e8s significatifs dans trois domaines\u00a0: son programme de travail, la mise \u00e0 jour du <em>guideline <\/em>ICH\u00a0Q4B et de ses annexes, et son programme d\u2019ouverture \u00e0 de nouveaux membres.<\/p><p>Une \u00e9tape importante a \u00e9t\u00e9 franchie en\u00a02024, avec l\u2019approbation, par l\u2019Assembl\u00e9e de l\u2019ICH, de la version modifi\u00e9e du <em>guideline\u00a0<\/em>ICH\u00a0Q4B et de la version r\u00e9vis\u00e9e de la proc\u00e9dure de travail (annexe\u00a05 de la proc\u00e9dure op\u00e9ratoire standardis\u00e9e (POS) des groupes de travail de l\u2019ICH), toutes deux relatives \u00e0 l\u2019harmonisation des pharmacop\u00e9es. Ces textes ont \u00e9t\u00e9 \u00e9labor\u00e9s par le GDP, puis pass\u00e9s en revue avec les membres de l\u2019ICH afin de parvenir \u00e0 un consensus. Au cours des ann\u00e9es \u00e0 venir, les travaux seront consacr\u00e9s \u00e0 la mise \u00e0 jour des d\u00e9clarations d\u2019interchangeabilit\u00e9 dans toutes les annexes du <em>guideline<\/em>\u00a0ICH\u00a0Q4B.<\/p><p>\u00c0 la suite de l\u2019int\u00e9gration de l\u2019IPC, le GDP a entrepris de se pencher sur les enseignements tir\u00e9s de son processus d\u2019ouverture \u00e0 des nouveaux membres. Fort de cette exp\u00e9rience, il a lanc\u00e9 la phase suivante, qui consiste \u00e0 inviter d\u2019autres pharmacop\u00e9es du monde \u00e0 faire acte de candidature. Cela lui permettra d\u2019\u00e9largir son rayonnement international et de renforcer l\u2019harmonisation des normes de pharmacop\u00e9e \u00e0 l\u2019\u00e9chelle plan\u00e9taire. Ce lancement marque le d\u00e9but du processus d\u2019accueil de nouvelles pharmacop\u00e9es au cours des prochaines ann\u00e9es. Le GDP proc\u00e8de \u00e9galement \u00e0 l\u2019\u00e9valuation et \u00e0 l\u2019am\u00e9lioration de ses m\u00e9thodes de travail afin de rester efficace malgr\u00e9 l\u2019augmentation du nombre de ses membres.<\/p><p>Le GDP a, en outre, entam\u00e9 une s\u00e9rie d\u2019\u00e9changes productifs sur les impuret\u00e9s nitrosamine \u2013 un sujet de haute importance. Les membres du groupe ont partag\u00e9 leurs connaissances et leurs exp\u00e9riences, abord\u00e9 des difficult\u00e9s sp\u00e9cifiques et explor\u00e9 des possibilit\u00e9s de collaboration pour l\u2019avenir.<\/p><p>Lors de sa r\u00e9union d\u2019octobre, le GDP a sign\u00e9 la version harmonis\u00e9e du chapitre g\u00e9n\u00e9ral sur les impuret\u00e9s \u00e9l\u00e9mentaires (G-07). La mise en \u0153uvre de ce chapitre harmonis\u00e9 et l\u2019application des concepts du <em>guideline\u00a0<\/em>ICH\u00a0Q3D favorisent l\u2019\u00e9laboration de monographies sp\u00e9cifiques dont les exigences en mati\u00e8re d\u2019impuret\u00e9s \u00e9l\u00e9mentaires sont uniformis\u00e9es entre les r\u00e9gions couvertes par les pharmacop\u00e9es membres. En tout, le GDP a harmonis\u00e9 avec succ\u00e8s et continue de tenir \u00e0 jour les 31\u00a0chapitres g\u00e9n\u00e9raux inscrits \u00e0 son programme de travail, dont des proc\u00e9dures analytiques aussi importantes que la chromatographie, l\u2019essai de dissolution, l\u2019essai de st\u00e9rilit\u00e9 et les essais de contr\u00f4le microbiologique. Il a, en outre, harmonis\u00e9 48\u00a0monographies d\u2019excipients. Une vingtaine de nouveaux textes figurent actuellement \u00e0 son programme de travail (<a href=\"https:\/\/www.edqm.eu\/fr\/harmonisation-status-for-general-texts-pdg-\" target=\"_blank\" rel=\"noopener\">chapitres g\u00e9n\u00e9raux<\/a>, <a href=\"https:\/\/www.edqm.eu\/fr\/harmonisation-status-for-excipient-monographs-pdg-\" target=\"_blank\" rel=\"noopener\">excipients<\/a>). Le groupe reste engag\u00e9 vers une plus grande reconnaissance des normes de pharmacop\u00e9e harmonis\u00e9es, dans le but de parvenir \u00e0 une convergence mondiale.<\/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-302fa6a elementor-section-stretched animated-slow elementor-section-boxed elementor-section-height-default elementor-section-height-default elementor-invisible\" data-id=\"302fa6a\" data-element_type=\"section\" data-e-type=\"section\" data-settings=\"{&quot;stretch_section&quot;:&quot;section-stretched&quot;,&quot;animation&quot;:&quot;fadeIn&quot;}\" data-no-translation=\"\">\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-95b3241\" data-id=\"95b3241\" data-element_type=\"column\" data-e-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-741f05a elementor-widget elementor-widget-heading\" data-id=\"741f05a\" data-element_type=\"widget\" data-e-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\">Publications, bases de donn\u00e9es et site web<\/h3>\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-be0660b elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"be0660b\" data-element_type=\"section\" data-e-type=\"section\" data-no-translation=\"\">\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-inner-column elementor-element elementor-element-28db27c\" data-id=\"28db27c\" data-element_type=\"column\" data-e-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-34bbb94 elementor-widget elementor-widget-heading\" data-id=\"34bbb94\" data-element_type=\"widget\" data-e-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\">Base de donn\u00e9es Standard Terms<\/h4>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-03f4da3 elementor-widget elementor-widget-text-editor\" data-id=\"03f4da3\" data-element_type=\"widget\" data-e-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>Initialement \u00e9labor\u00e9e \u00e0 la demande de la Commission europ\u00e9enne pour les dossiers d\u2019autorisation de mise sur le march\u00e9, la base de donn\u00e9es Standard Terms contient des termes normalis\u00e9s permettant aux utilisateurs et utilisatrices comme aux prescripteurs et prescriptrices de disposer d\u2019un vocabulaire harmonis\u00e9 pour d\u00e9crire les formes pharmaceutiques, les voies d\u2019administration, les unit\u00e9s de pr\u00e9sentation, ainsi que les r\u00e9cipients, les fermetures et les dispositifs d\u2019administration des m\u00e9dicaments. La liste des termes normalis\u00e9s est disponible en 35\u00a0langues.<\/p><p>La base de donn\u00e9es comprend \u00e9galement une section \u00ab\u00a0Mapped terms\u00a0\u00bb, qui permet l\u2019introduction de termes issus de bases de donn\u00e9es externes du monde entier et leur mise en correspondance avec les termes normalis\u00e9s, ainsi que des services web (\u00e9galement appel\u00e9s \u00ab\u00a0interfaces de programmation\u00a0\u00bb) qui permettent aux personnes inscrites d\u2019extraire des donn\u00e9es directement \u00e0 partir de la base pour les int\u00e9grer dans leurs propres syst\u00e8mes.<\/p><p>En\u00a02024, 13\u00a0termes normalis\u00e9s ont \u00e9t\u00e9 ajout\u00e9s, huit ont \u00e9t\u00e9 r\u00e9vis\u00e9s et plus de 450\u00a0traductions ont \u00e9t\u00e9 ajout\u00e9es ou mises \u00e0 jour. Plus de 3\u00a0700 comptes utilisateur ont \u00e9t\u00e9 cr\u00e9\u00e9s et le site web a re\u00e7u pr\u00e8s de 40\u00a0000\u00a0visites.<\/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-82ae2b6 elementor-widget elementor-widget-image\" data-id=\"82ae2b6\" data-element_type=\"widget\" data-e-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=\"1636\" height=\"388\" src=\"https:\/\/annualreport-2025.guerillainteractive.co.uk\/wp-content\/uploads\/2024\/06\/Funded-EU-and-COE-Implemented-COE-quadri-fr.png\" class=\"attachment-full size-full wp-image-939\" alt=\"\" srcset=\"https:\/\/annualreport-2025.guerillainteractive.co.uk\/wp-content\/uploads\/2024\/06\/Funded-EU-and-COE-Implemented-COE-quadri-fr.png 1636w, 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Eur. monographs The European Network of Official Medicines Control Laboratories Anti-falsification activities Pharmaceuticals and pharmaceutical care European Pediatric Formulary Liens utiles \u00c9talons de r\u00e9f\u00e9rence Certification de conformit\u00e9 aux monographies de la Ph. 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