{"id":345,"date":"2024-04-24T15:45:43","date_gmt":"2024-04-24T15:45:43","guid":{"rendered":"http:\/\/annualreport.edqm.eu\/?page_id=345"},"modified":"2024-06-11T11:20:44","modified_gmt":"2024-06-11T11:20:44","slug":"the-european-pharmacopoeia","status":"publish","type":"page","link":"https:\/\/annualreport2023.edqm.eu\/fr\/the-european-pharmacopoeia\/","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-2f95b880 elementor-section-height-min-height elementor-section-stretched elementor-section-boxed elementor-section-height-default elementor-section-items-middle elementor-invisible\" data-id=\"2f95b880\" 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<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-380f7e76\" data-id=\"380f7e76\" 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;fadeInUp&quot;,&quot;background_background&quot;:&quot;classic&quot;,&quot;animation_mobile&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-bdca665 elementor-widget elementor-widget-heading\" data-id=\"bdca665\" 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\">Liens rapides<\/h4>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-671e64c elementor-widget__width-auto elementor-widget elementor-widget-button\" data-id=\"671e64c\" data-element_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<style>.elementor-element-671e64c{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-4477a78 elementor-widget__width-auto elementor-widget elementor-widget-button\" data-id=\"4477a78\" data-element_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-be028d5 elementor-widget__width-auto elementor-widget elementor-widget-button\" data-id=\"be028d5\" 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\/reference-standards\/\">\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-e7bd6fd elementor-widget__width-auto elementor-widget elementor-widget-button\" data-id=\"e7bd6fd\" 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\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-6f22971 elementor-widget__width-auto elementor-widget elementor-widget-button\" data-id=\"6f22971\" 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\/european-network-of-official-medicines-control-laboratories\/\">\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-8aab23e elementor-widget__width-auto elementor-widget elementor-widget-button\" data-id=\"8aab23e\" 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\t\t\t<span class=\"elementor-button-text\">Contamination par des nitrosamines : les r\u00e9ponses apport\u00e9es par l\u2019EDQM<\/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-0f82131 elementor-widget__width-auto elementor-widget elementor-widget-button\" data-id=\"0f82131\" 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\/anti-falsification-activities\/\">\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-208397b elementor-widget__width-auto elementor-widget elementor-widget-button\" data-id=\"208397b\" 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\/pharmaceuticals-and-pharmaceutical-care\/\">\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-d231807 elementor-widget__width-auto elementor-widget elementor-widget-button\" data-id=\"d231807\" 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\/european-paediatric-formulary\/\">\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-3c6a80b elementor-section-stretched animated-slow elementor-section-boxed elementor-section-height-default elementor-section-height-default elementor-invisible\" data-id=\"3c6a80b\" data-element_type=\"section\" id=\"europeanpharmacopoeia\" 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-1dc04a5\" data-id=\"1dc04a5\" data-element_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-31aa2d4 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"31aa2d4\" 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-d399ded\" data-id=\"d399ded\" 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-8ba7195 elementor-widget elementor-widget-heading\" data-id=\"8ba7195\" data-element_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-8ba7195{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-9becd7a elementor-widget elementor-widget-heading\" data-id=\"9becd7a\" data-element_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<h1 class=\"elementor-heading-title elementor-size-default\">Pharmacop\u00e9e Europ\u00e9enne<\/h1>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-2fff979 elementor-widget elementor-widget-text-editor\" data-id=\"2fff979\" 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>La Pharmacop\u00e9e Europ\u00e9enne (Ph. Eur.) est un ouvrage de r\u00e9f\u00e9rence unique en mati\u00e8re de contr\u00f4le qualit\u00e9 des m\u00e9dicaments dans les 39 \u00c9tats membres de la Ph. Eur. ayant ratifi\u00e9 la Convention relative \u00e0 l\u2019\u00e9laboration d\u2019une Pharmacop\u00e9e europ\u00e9enne. Elle fournit une base juridique et scientifique au contr\u00f4le qualit\u00e9 des m\u00e9dicaments et de leurs composants pendant les phases de d\u00e9veloppement, de production et de commercialisation, dans le but de promouvoir et de prot\u00e9ger la sant\u00e9 publique. Ses normes qualit\u00e9 sont juridiquement contraignantes pour tous les producteurs de m\u00e9dicaments et\/ou de substances pour usage pharmaceutique souhaitant commercialiser leurs produits dans les \u00c9tats membres de la Ph. Eur. En outre, elles facilitent la libre circulation des m\u00e9dicaments en Europe et au-del\u00e0. La Ph. Eur. est largement utilis\u00e9e \u00e0 travers le globe, car la mondialisation et l\u2019expansion du commerce international rendent plus que jamais n\u00e9cessaire l\u2019\u00e9laboration de normes qualit\u00e9 r\u00e9gissant les m\u00e9dicaments \u00e0 l\u2019\u00e9chelle mondiale.<\/strong><\/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-436b7b7\" data-id=\"436b7b7\" 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-f068433 elementor-widget elementor-widget-image\" data-id=\"f068433\" 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=\"2560\" height=\"1521\" src=\"https:\/\/annualreport2023.edqm.eu\/wp-content\/uploads\/2024\/06\/PhEur-11th-Visual-EN-vials-FINAL-scaled.jpg\" class=\"attachment-full size-full wp-image-741\" alt=\"\" srcset=\"https:\/\/annualreport2023.edqm.eu\/wp-content\/uploads\/2024\/06\/PhEur-11th-Visual-EN-vials-FINAL-scaled.jpg 2560w, https:\/\/annualreport2023.edqm.eu\/wp-content\/uploads\/2024\/06\/PhEur-11th-Visual-EN-vials-FINAL-300x178.jpg 300w, https:\/\/annualreport2023.edqm.eu\/wp-content\/uploads\/2024\/06\/PhEur-11th-Visual-EN-vials-FINAL-1024x608.jpg 1024w, https:\/\/annualreport2023.edqm.eu\/wp-content\/uploads\/2024\/06\/PhEur-11th-Visual-EN-vials-FINAL-768x456.jpg 768w, https:\/\/annualreport2023.edqm.eu\/wp-content\/uploads\/2024\/06\/PhEur-11th-Visual-EN-vials-FINAL-1536x912.jpg 1536w, https:\/\/annualreport2023.edqm.eu\/wp-content\/uploads\/2024\/06\/PhEur-11th-Visual-EN-vials-FINAL-2048x1216.jpg 2048w\" sizes=\"(max-width: 2560px) 100vw, 2560px\" \/>\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-6d4de0a elementor-section-stretched animated-slow elementor-section-boxed elementor-section-height-default elementor-section-height-default elementor-invisible\" data-id=\"6d4de0a\" 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-b8711f9\" data-id=\"b8711f9\" 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-ddf966f elementor-widget elementor-widget-heading\" data-id=\"ddf966f\" 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\">Une croissance continue au service de nos parties int\u00e9ress\u00e9es<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-439b29f elementor-widget elementor-widget-text-editor\" data-id=\"439b29f\" 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\">Au cours de l\u2019ann\u00e9e 2023, 172 textes (nouveaux et r\u00e9vis\u00e9s) ont \u00e9t\u00e9 publi\u00e9s pour enqu\u00eate publique, dans les num\u00e9ros 35.1 \u00e0 35.4 de <em>Pharmeuropa<\/em> (la plateforme de commentaires en ligne de la Ph. Eur.) et, au total, 32 nouvelles monographies, cinq nouveaux chapitres g\u00e9n\u00e9raux et 192 textes 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 b\u00e9n\u00e9volement son temps et ses comp\u00e9tences techniques, la communaut\u00e9 mondiale d\u2019expert\u00b7es de la Ph. Eur. poursuit la production de contenus d\u2019une grande richesse dans des domaines vari\u00e9s, comme soulign\u00e9 ci-apr\u00e8s. Ces textes \u2013 nouveaux ou r\u00e9vis\u00e9s \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 sont applicables \u00e0 des produits pr\u00e9sentant un grand int\u00e9r\u00eat sur le march\u00e9 et \u00e0 des domaines \u00e9mergents. Ils contribuent ainsi \u00e0 la protection de la sant\u00e9 publique dans les 39 \u00c9tats membres de la Ph. Eur. et dans les 130 pays o\u00f9 ils sont appliqu\u00e9s. En outre, 43 textes portant sur d\u2019autres sujets d\u2019int\u00e9r\u00eat ont \u00e9t\u00e9 inscrits au programme de travail et l\u2019EPC, toujours soucieuse de pr\u00e9parer l\u2019avenir, a cr\u00e9\u00e9 cinq nouveaux groupes de travail (GT).<\/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-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\">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-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>Les travaux de la Ph. Eur. sont pilot\u00e9s par une communaut\u00e9 internationale dynamique d\u2019expert\u00b7es. Ce r\u00e9seau comprend des repr\u00e9sentant\u00b7es des Autorit\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 monde universitaire, d\u2019organismes de recherche et d\u2019autres secteurs d\u2019activit\u00e9. Hautement qualifi\u00e9es, ces personnes partagent leur expertise et leur exp\u00e9rience au sein des 61 groupes d\u2019expert\u00b7es et GT aupr\u00e8s desquels elles sont nomm\u00e9es pour trois ans par l\u2019EPC. Les mandats co\u00efncident donc avec le cycle de publication de chaque nouvelle \u00e9dition de la Ph. Eur. En 2023, 955 expert\u00b7es ont continu\u00e9 \u00e0 consacrer leur temps et leur \u00e9nergie \u00e0 l\u2019\u00e9laboration des normes publiques de la Ph. Eur. Ces expert\u00b7es forment l\u2019\u00e9pine dorsale de la Ph. Eur. et assurent le lien essentiel entre exp\u00e9rimentation pratique 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-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\">Pr\u00e9parer l\u2019avenir : trois nouveaux GT<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-a73805e elementor-widget elementor-widget-text-editor\" data-id=\"a73805e\" 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-a73805e{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-dd31a8c elementor-widget elementor-widget-text-editor\" data-id=\"dd31a8c\" 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>Dans le cadre de la strat\u00e9gie d\u2019anticipation d\u00e9ploy\u00e9e par la Ph. Eur., il est essentiel de pr\u00e9voir les besoins relatifs \u00e0 l\u2019application de nouvelles technologies d\u2019analyse afin d\u2019ouvrir, en temps opportun, les r\u00e9flexions et discussions sur les tendances et difficult\u00e9s potentielles. \u00c0 cette fin, en 2023, trois nouveaux GT ont d\u00e9but\u00e9 leurs travaux.<\/p><p>Le <strong>GT EXS (Strat\u00e9gie relative aux excipients)<\/strong>, cr\u00e9\u00e9 par l\u2019EPC en 2022, est charg\u00e9, depuis 2023, de se pencher sur les sp\u00e9cificit\u00e9s des excipients dans les monographies de la Ph. Eur. et de r\u00e9fl\u00e9chir \u00e0 la meilleure mani\u00e8re de poursuivre le d\u00e9veloppement de la strat\u00e9gie de la Ph. Eur. relative \u00e0 ces ingr\u00e9dients pharmaceutiques majeurs.<\/p><p>Le <strong>GT ALU (Aluminium dans les solutions de nutrition parent\u00e9rale)<\/strong> a \u00e9t\u00e9 mis sur pied en 2023 pour s\u2019atteler \u00e0 une t\u00e2che bien particuli\u00e8re, \u00e0 savoir \u00e9tablir une norme europ\u00e9enne pour limiter la teneur maximale en aluminium des solutions de nutrition parent\u00e9rale.<\/p><p>Le <strong>GT NANO (Nanom\u00e9dicaments)<\/strong> n\u2019est pas exactement une nouveaut\u00e9 : il s\u2019agit de l\u2019ancien GT NBC (Complexes non biologiques), renomm\u00e9 afin de mieux refl\u00e9ter les types de substances et de produits couverts par ses travaux. Les r\u00e9flexions relatives aux nanom\u00e9dicaments se sont intensifi\u00e9es en r\u00e9ponse aux observations dont les parties int\u00e9ress\u00e9es ont fait part lors du symposium organis\u00e9 sur ce sujet par l\u2019EDQM, en juin 2022. Les expert\u00b7es de ce GT \u00e9largi entendent travailler sur d\u2019autres types de nanom\u00e9dicaments que les complexes fer\/hydrates de carbone, notamment les formulations liposomales.<\/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-88d2513 elementor-section-stretched animated-slow elementor-section-boxed elementor-section-height-default elementor-section-height-default elementor-invisible\" data-id=\"88d2513\" 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-8ffe394\" data-id=\"8ffe394\" 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-5acecab elementor-widget elementor-widget-heading\" data-id=\"5acecab\" 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\">Autres activit\u00e9s men\u00e9es en 2023<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-9d2d99c elementor-widget elementor-widget-heading\" data-id=\"9d2d99c\" 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\">Principe des 3R<\/h4>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-a4880ae elementor-widget elementor-widget-text-editor\" data-id=\"a4880ae\" 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-a4880ae{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-890eb09 elementor-widget elementor-widget-text-editor\" data-id=\"890eb09\" 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 class=\"translation-block\">Depuis l\u2019adoption de la\u00a0<span style=\"text-decoration: underline;\"><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><\/span> (Conseil de l\u2019Europe, STE n\u1d52 123) en 1986, l\u2019EPC et ses expert\u00b7es veillent \u00e0 proposer un programme de travail visant \u00e0 <strong>remplacer, r\u00e9duire et raffiner<\/strong> l\u2019utilisation des animaux \u00e0 des fins exp\u00e9rimentales (principe des 3R). \u00c0 l\u2019\u00e9chelle de l\u2019Union europ\u00e9enne (UE), la\u00a0<a href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2010\/63\/oj?locale=fr\" target=\"_blank\" rel=\"noopener\"><span style=\"text-decoration: underline;\">directive 2010\/63\/UE relative \u00e0 la protection des animaux utilis\u00e9s \u00e0 des fins scientifiques<\/span><\/a>\u00a0d\u00e9conseille fortement l\u2019utilisation d\u2019animaux pour tester des m\u00e9dicaments.<\/p><p class=\"translation-block\">L\u2019essai des pyrog\u00e8nes sur lapin a \u00e9t\u00e9 d\u00e9crit pour la premi\u00e8re fois dans la Ph. Eur. en 1986. Il consiste \u00e0 mesurer l\u2019\u00e9l\u00e9vation de temp\u00e9rature induite chez le lapin par l\u2019injection intraveineuse d\u2019une solution st\u00e9rile de la substance \u00e0 examiner. Lors de sa 170<sup>e<\/sup> session (juin 2021), l\u2019EPC s\u2019est engag\u00e9e \u00e0 proc\u00e9der, dans un d\u00e9lai de cinq ans, au remplacement total de l\u2019essai des pyrog\u00e8nes sur lapin dans la Ph. Eur. Cette strat\u00e9gie a \u00e9t\u00e9 pr\u00e9cis\u00e9e en 2022, ce qui a abouti \u00e0 l\u2019\u00e9laboration du chapitre g\u00e9n\u00e9ral <em>Pyrog\u00e9nicit\u00e9 (5.1.13)<\/em>, qui guidera les utilisateurs et utilisatrices dans le choix et la mise en \u0153uvre d\u2019un essai appropri\u00e9 pour contr\u00f4ler la pyrog\u00e9nicit\u00e9 de leurs produits (essai des endotoxines bact\u00e9riennes [EEB] ou essai d\u2019activation des monocytes [MAT]). La r\u00e9vision des 59 textes faisant r\u00e9f\u00e9rence \u00e0 l\u2019essai des pyrog\u00e8nes sur lapin a \u00e9galement \u00e9t\u00e9 engag\u00e9e. Ces textes, qui couvrent des sujets aussi divers que les vaccins pour usage humain, les produits du sang, les antibiotiques, les produits radiopharmaceutiques ou les r\u00e9cipients, ont \u00e9t\u00e9 publi\u00e9s pour enqu\u00eate publique dans\u00a0<em>Pharmeuropa 35.1<\/em>, en janvier 2023. Les commentaires re\u00e7us ont depuis \u00e9t\u00e9 compil\u00e9s, dans l\u2019optique de soumettre l\u2019ensemble \u00e0 l\u2019EPC en 2024.<\/p><p>Par ailleurs, en f\u00e9vrier 2023, l\u2019EDQM et le Partenariat europ\u00e9en pour la promotion des m\u00e9thodes de substitution \u00e0 l\u2019exp\u00e9rimentation animale (EPAA) ont co-organis\u00e9, dans les locaux de la Commission europ\u00e9enne et en ligne, un \u00e9v\u00e9nement de trois jours ax\u00e9 sur l\u2019avenir du contr\u00f4le de la pyrog\u00e9nicit\u00e9 et sur la promotion d\u2019une strat\u00e9gie globale d\u2019essais ne n\u00e9cessitant pas le recours aux animaux.<\/p><p class=\"translation-block\">En 2023, le chapitre g\u00e9n\u00e9ral\u00a0<em>Essai d\u2019activation des monocytes (2.6.30)<\/em>\u00a0a \u00e9t\u00e9 r\u00e9vis\u00e9 afin de rationaliser l\u2019essai et de le mettre en phase avec les pratiques actuelles, ce qui repr\u00e9sente un pas significatif vers l\u2019\u00e9limination de l\u2019essai des pyrog\u00e8nes sur lapin de la Ph. Eur. De la m\u00eame mani\u00e8re, l\u2019EPC a adopt\u00e9 un nouveau MAT pour les vaccins contenant des compos\u00e9s intrins\u00e8quement pyrog\u00e8nes\u00a0<em>(2.6.40)<\/em>. Ce texte couvre le recours au MAT pour surveiller la reproductibilit\u00e9 de la production des vaccins intrins\u00e8quement pyrog\u00e8nes et sera d\u2019une grande aide aux parties int\u00e9ress\u00e9es souhaitant le mettre en \u0153uvre pour ces vaccins.<\/p><p class=\"translation-block\">L\u2019EPC est d\u00e9sireuse de promouvoir les technologies de pointe et d\u2019\u00e9viter l\u2019utilisation de r\u00e9actifs d\u2019origine animale. Par cons\u00e9quent, deux monographies couvrant l\u2019eau de qualit\u00e9 pharmaceutique\u00a0<em>(Eau pour pr\u00e9parations injectables (0169)<\/em>\u00a0et\u00a0<em>Eau purifi\u00e9e (0008)<\/em>) ont \u00e9t\u00e9 r\u00e9vis\u00e9es afin d\u2019y introduire la possibilit\u00e9 d\u2019effectuer l\u2019EEB par la m\u00e9thode du facteur C recombinant (rFC).<\/p><p class=\"translation-block\">Dans le domaine des m\u00e9dicaments v\u00e9t\u00e9rinaires, 14 monographies de vaccins v\u00e9t\u00e9rinaires ont \u00e9t\u00e9 r\u00e9vis\u00e9es comme suit afin de promouvoir le bien-\u00eatre animal : r\u00e9duction, dans huit d\u2019entre elles, du nombre de contr\u00f4les effectu\u00e9s dans le cadre des essais d\u2019activit\u00e9 du lot\u00a0<em>in vivo<\/em>\u00a0; ajout, dans trois de ces monographies, de points limites plus pr\u00e9coces (pouvoir immunog\u00e8ne) ; suppression, dans neuf de ces textes, de l\u2019essai\u00a0<em>in vivo<\/em>\u00a0du virus vivant r\u00e9siduel au stade du produit final (lorsqu\u2019il n\u2019y a pas de retour \u00e0 la virulence), remplac\u00e9 par l\u2019essai en cours de fabrication, effectu\u00e9 de pr\u00e9f\u00e9rence sur cultures cellulaires. Tous les essais du virus vivant r\u00e9siduel restants sont effectu\u00e9s\u00a0<em>in vitro<\/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\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\">Faits marquants<\/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-440e462 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"440e462\" 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-c23921d\" data-id=\"c23921d\" 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-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\">Nouvelle monographie : <i>Oxyg\u00e8ne \u00e0 98 pour cent (3098)<\/i><\/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 class=\"translation-block\">L\u2019EPC a adopt\u00e9 une nouvelle monographie, <em>Oxyg\u00e8ne \u00e0 98 pour cent (3098)<\/em>, qui permettra aux \u00e9tablissements de sant\u00e9 de contr\u00f4ler la qualit\u00e9 de l\u2019oxyg\u00e8ne produit sur place \u00e0 l\u2019aide d\u2019un proc\u00e9d\u00e9 d\u2019adsorption \u00ab double \u00e9tage \u00bb permettant d\u2019\u00e9liminer l\u2019azote et l\u2019argon de l\u2019air. L\u2019\u00e9laboration de ce texte s\u2019est accompagn\u00e9e de d\u00e9fis consid\u00e9rables, tels que l\u2019adaptation de la production de ce type d\u2019oxyg\u00e8ne selon un proc\u00e9d\u00e9 continu dans des environnements non industriels (dans les h\u00f4pitaux, par exemple). Des interrogations ont \u00e9galement \u00e9t\u00e9 soulev\u00e9es quant \u00e0 l\u2019applicabilit\u00e9 des essais d\u00e9crits dans les monographies existantes de la Ph. Eur. couvrant l\u2019oxyg\u00e8ne. Par cons\u00e9quent, l\u2019EPC a d\u00e9cid\u00e9 de r\u00e9viser les monographies <em>Oxyg\u00e8ne (0417)<\/em> et <em>Oxyg\u00e8ne \u00e0 93 pour cent (2455)<\/em> pour en harmoniser les strat\u00e9gies de contr\u00f4le avec celle de la monographie <em>Oxyg\u00e8ne \u00e0 98 pour cent<\/em> tout juste adopt\u00e9e.<\/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-15d70f1\" data-id=\"15d70f1\" 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-6650c46 elementor-widget elementor-widget-heading\" data-id=\"6650c46\" 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\">Informations essentielles destin\u00e9es aux utilisateurs et utilisatrices des monographies<\/h4>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-0340d0e elementor-widget elementor-widget-text-editor\" data-id=\"0340d0e\" 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\">En juin 2023, l\u2019EPC a adopt\u00e9 un nouveau chapitre g\u00e9n\u00e9ral, intitul\u00e9 <em>Comparabilit\u00e9 des proc\u00e9dures analytiques alternatives (5.27)<\/em>, depuis publi\u00e9 \u2013 \u00e0 titre informatif \u2013 dans le Suppl\u00e9ment 11.5 de la Ph. Eur. (janvier 2024). Il ne contient aucune nouvelle exigence qui ne figure d\u00e9j\u00e0 dans la section 1.1.2.5 des <em>Prescriptions g\u00e9n\u00e9rales<\/em> de la Ph. Eur. Le chapitre g\u00e9n\u00e9ral <em>5.27<\/em> contient des informations pratiques pour aider les utilisateurs et utilisatrices souhaitant appliquer une proc\u00e9dure analytique alternative au lieu de la proc\u00e9dure de pharmacop\u00e9e, dans le cadre de leur strat\u00e9gie de contr\u00f4le, \u00e0 d\u00e9montrer la comparabilit\u00e9 desdites proc\u00e9dures. Il pr\u00e9cise, par ailleurs, que cette comparabilit\u00e9 doit \u00eatre maintenue tout au long du cycle de vie des deux proc\u00e9dures analytiques.<\/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-5ab5a987 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"5ab5a987\" 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-6300ba55\" data-id=\"6300ba55\" 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-44dcf700 elementor-widget elementor-widget-image\" data-id=\"44dcf700\" data-element_type=\"widget\" data-no-translation=\"\" data-widget_type=\"image.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<style>.elementor-element-44dcf700{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-38687c0 no-margin elementor-widget elementor-widget-image\" data-id=\"38687c0\" data-element_type=\"widget\" data-no-translation=\"\" 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<figure class=\"wp-caption\">\n\t\t\t\t\t\t\t\t\t\t\t<a href=\"https:\/\/www.edqm.eu\/fr\/-\/edqm-publishes-2nd-edition-of-herbal-guide\" target=\"_blank\">\n\t\t\t\t\t\t\t<img decoding=\"async\" width=\"1810\" height=\"2560\" src=\"https:\/\/annualreport2023.edqm.eu\/wp-content\/uploads\/2024\/06\/07-PHEUR-EN-Guide-for-the-elaboration-of-monographs-on-herbal-drugs-2023-COVER-scaled.jpg\" class=\"attachment-full size-full wp-image-987\" alt=\"\" srcset=\"https:\/\/annualreport2023.edqm.eu\/wp-content\/uploads\/2024\/06\/07-PHEUR-EN-Guide-for-the-elaboration-of-monographs-on-herbal-drugs-2023-COVER-scaled.jpg 1810w, https:\/\/annualreport2023.edqm.eu\/wp-content\/uploads\/2024\/06\/07-PHEUR-EN-Guide-for-the-elaboration-of-monographs-on-herbal-drugs-2023-COVER-212x300.jpg 212w, https:\/\/annualreport2023.edqm.eu\/wp-content\/uploads\/2024\/06\/07-PHEUR-EN-Guide-for-the-elaboration-of-monographs-on-herbal-drugs-2023-COVER-724x1024.jpg 724w, https:\/\/annualreport2023.edqm.eu\/wp-content\/uploads\/2024\/06\/07-PHEUR-EN-Guide-for-the-elaboration-of-monographs-on-herbal-drugs-2023-COVER-768x1086.jpg 768w, https:\/\/annualreport2023.edqm.eu\/wp-content\/uploads\/2024\/06\/07-PHEUR-EN-Guide-for-the-elaboration-of-monographs-on-herbal-drugs-2023-COVER-1086x1536.jpg 1086w, https:\/\/annualreport2023.edqm.eu\/wp-content\/uploads\/2024\/06\/07-PHEUR-EN-Guide-for-the-elaboration-of-monographs-on-herbal-drugs-2023-COVER-1448x2048.jpg 1448w, https:\/\/annualreport2023.edqm.eu\/wp-content\/uploads\/2024\/06\/07-PHEUR-EN-Guide-for-the-elaboration-of-monographs-on-herbal-drugs-2023-COVER-8x12.jpg 8w\" sizes=\"(max-width: 1810px) 100vw, 1810px\" \/>\t\t\t\t\t\t\t\t<\/a>\n\t\t\t\t\t\t\t\t\t\t\t<figcaption class=\"widget-image-caption wp-caption-text\"><\/figcaption>\n\t\t\t\t\t\t\t\t\t\t<\/figure>\n\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-abed845 elementor-widget elementor-widget-text-editor\" data-id=\"abed845\" 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>Guide for the elaboration of monographs on herbal drugs and herbal drug preparations, 2<sup>e<\/sup> \u00e9dition (en anglaise uniquement)<\/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-2fed2cd0\" data-id=\"2fed2cd0\" 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\">Drogues v\u00e9g\u00e9tales<\/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-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-5038f28{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-a729e2a elementor-widget elementor-widget-text-editor\" data-id=\"a729e2a\" 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>En raison de l\u2019int\u00e9r\u00eat croissant suscit\u00e9 par les applications m\u00e9dicinales du cannabis et de la n\u00e9cessit\u00e9 d\u2019\u00e9tablir des normes scientifiques en r\u00e9gissant la qualit\u00e9, l\u2019EPC a ajout\u00e9 cette plante \u00e0 son programme de travail, il y a plusieurs ann\u00e9es. Depuis lors, l\u2019\u00e9laboration d\u2019une monographie a \u00e9t\u00e9 confi\u00e9e au Groupe d\u2019Experts 13B, dont les membres ont travaill\u00e9 sans rel\u00e2che pour faire le point sur les r\u00e9glementations nationales tr\u00e8s diverses qui coexistent et pour recueillir des informations aupr\u00e8s de diff\u00e9rentes Autorit\u00e9s nationales sur l\u2019utilisation de cette drogue v\u00e9g\u00e9tale dans leurs juridictions respectives, ainsi que sur sa qualit\u00e9. La monographie Fleur de cannabis (3028) a \u00e9t\u00e9 adopt\u00e9e par l\u2019EPC, en juin 2023. Elle a \u00e9t\u00e9 publi\u00e9e dans le Suppl\u00e9ment 11.5 de la Ph. Eur. (janvier 2024) et sera applicable \u00e0 compter du 1<sup>er<\/sup> juillet 2024. Elle couvre la drogue v\u00e9g\u00e9tale pouvant \u00eatre employ\u00e9e comme mati\u00e8re premi\u00e8re pour la production d\u2019extraits ou \u00eatre prescrite telle quelle aux personnes trait\u00e9es, en vue d\u2019une administration par inhalation ou par voie orale.<\/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-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-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\">Section Caract\u00e9ristiques li\u00e9es \u00e0 la fonctionnalit\u00e9<\/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>Cinq monographies d\u2019excipients ont \u00e9t\u00e9 r\u00e9vis\u00e9es, puis publi\u00e9es dans le Suppl\u00e9ment 11.2 (janvier 2023), pour y inclure une section Caract\u00e9ristiques li\u00e9es \u00e0 la fonctionnalit\u00e9 (CLF), ce qui porte \u00e0 plus d\u2019une centaine le nombre total de monographies de la Ph. Eur. dot\u00e9es d\u2019une section de ce genre. Cette \u00e9tape importante met en lumi\u00e8re le travail consid\u00e9rable accompli par le GT EXP (Performance des excipients) depuis que la Ph. Eur. a pris la d\u00e9cision novatrice d\u2019introduire pour la premi\u00e8re fois une section CLF dans une monographie, en 2008. Les sections CLF d\u00e9crivent les caract\u00e9ristiques physiques ou chimiques d\u2019un excipient influant sur une ou plusieurs de ses fonctions, lors de son utilisation pour des applications sp\u00e9cifiques dans le produit final.<\/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-38a33cc elementor-widget elementor-widget-heading\" data-id=\"38a33cc\" 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\">Contamination par l\u2019\u00e9thyl\u00e8neglycol et le di\u00e9thyl\u00e8neglycol : les actions prises par l\u2019EPC<\/h4>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-b585986 elementor-widget elementor-widget-text-editor\" data-id=\"b585986\" 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\">Afin de r\u00e9pondre au risque pour la sant\u00e9 publique li\u00e9 \u00e0 la contamination de plusieurs m\u00e9dicaments par l\u2019\u00e9thyl\u00e8neglycol (EG) et le di\u00e9thyl\u00e8neglycol (DEG), mise au jour dans plusieurs pays d\u2019Afrique et d\u2019Asie (<span style=\"text-decoration: underline;color: #ffffff\"><a style=\"color: #ffffff;text-decoration: underline\" href=\"https:\/\/www.who.int\/teams\/regulation-prequalification\/incidents-and-SF\/full-list-of-who-medical-product-alerts\" target=\"_blank\" rel=\"noopener\">alertes n\u00ba 6-7\/2022, n\u00ba 1\/2023 et n\u00ba 4-6\/2023 de l\u2019OMS<\/a><\/span>), l\u2019EPC a adopt\u00e9 une version r\u00e9vis\u00e9e de la monographie <em>Propyl\u00e8neglycol (0430)<\/em>. Devant l\u2019urgence de ce probl\u00e8me de sant\u00e9 publique, l\u2019EPC a d\u00e9cid\u00e9 de rendre la monographie imm\u00e9diatement disponible sur le site web de l\u2019EDQM pour permettre aux utilisateurs et utilisatrices d\u2019anticiper le changement \u00e0 venir et de se familiariser avec la proc\u00e9dure analytique correspondante. En outre, l\u2019EPC et ses groupes de travail \u00e9valuent actuellement la n\u00e9cessit\u00e9 d\u2019actualiser d\u2019autres monographies.<\/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-377782e elementor-section-stretched animated-slow elementor-section-boxed elementor-section-height-default elementor-section-height-default elementor-invisible\" data-id=\"377782e\" 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-9257dff\" data-id=\"9257dff\" 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-1133056 no-margin elementor-widget elementor-widget-heading\" data-id=\"1133056\" 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\">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-4e08e19 elementor-widget elementor-widget-heading\" data-id=\"4e08e19\" 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 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-51bdb81 elementor-widget elementor-widget-text-editor\" data-id=\"51bdb81\" 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 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 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 visant \u00e0 remplacer les essais de laboratoire sur animaux, selon le principe des 3R.<\/p><p class=\"translation-block\">En 2023, dans le cadre de ce programme, 21 projets 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. Six d\u2019entre eux sont arriv\u00e9s \u00e0 leur terme au cours de l\u2019ann\u00e9e : deux projets li\u00e9s \u00e0 l\u2019\u00e9valuation de nouvelles m\u00e9thodes et quatre ayant permis l\u2019\u00e9tablissement de PBR\/RBR de remplacement (voir <a href=\"http:\/\/annualreport2023.edqm.eu\/fr\/reference-standards\/\" target=\"_self\"><span style=\"text-decoration: underline\"><em>\u00c9talons de r\u00e9f\u00e9rence<\/em><\/span><\/a>).<\/p><p>L\u2019EDQM a men\u00e9 huit autres projets portant sur l\u2019\u00e9tablissement de lots de remplacement d\u2019\u00e9talons de r\u00e9f\u00e9rence existants et trois sur l\u2019\u00e9tablissement d\u2019un nouvel \u00e9talon de r\u00e9f\u00e9rence pour des produits biologiques.<\/p><p>Quatre projets en cours sont ax\u00e9s sur le d\u00e9veloppement de nouvelles m\u00e9thodes de pharmacop\u00e9e. Trois d\u2019entre eux concernent l\u2019application du principe des 3R 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-fbaadd6 elementor-widget elementor-widget-image\" data-id=\"fbaadd6\" 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=\"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\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-d4f24b7 elementor-section-stretched animated-slow elementor-section-boxed elementor-section-height-default elementor-section-height-default elementor-invisible\" data-id=\"d4f24b7\" 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-442487c\" data-id=\"442487c\" 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-40b39da elementor-widget elementor-widget-heading\" data-id=\"40b39da\" 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\">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-7481e16 elementor-widget elementor-widget-heading\" data-id=\"7481e16\" 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\">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-4e32b69 elementor-widget elementor-widget-text-editor\" data-id=\"4e32b69\" 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 octobre 2023, le Groupe de discussion des pharmacop\u00e9es (GDP) a eu l\u2019honneur d\u2019accueillir, pour la premi\u00e8re fois en 34 ans d\u2019existence, un nouveau membre : la Commission indienne de Pharmacop\u00e9e (IPC) \u00e0 l\u2019issue d\u2019un projet pilote d\u2019un an. L\u2019IPC joint donc ses forces \u00e0 celles de la Ph. Eur., de la Pharmacop\u00e9e japonaise (JP) et de la Pharmacop\u00e9e des \u00c9tats-Unis (USP) \u2013 membres fondateurs du groupe \u2013, qui \u0153uvrent, aux c\u00f4t\u00e9s de l\u2019OMS \u2013 membre observateur \u2013, en faveur d\u2019une plus grande reconnaissance des normes de pharmacop\u00e9e harmonis\u00e9es, dans l\u2019objectif de parvenir \u00e0 une convergence mondiale. Les enseignements tir\u00e9s de cette exp\u00e9rience serviront \u00e0 ajuster et \u00e0 affiner les m\u00e9thodes de travail du groupe et \u00e0 identifier les changements n\u00e9cessaires pour veiller \u00e0 ce que le GDP continue \u00e0 fonctionner efficacement avec davantage de membres.<\/p><p>L\u2019une des principales r\u00e9ussites du GDP en 2023 a \u00e9t\u00e9 l\u2019obtention, en juin, du consensus de l\u2019Assembl\u00e9e de l\u2019ICH sur l\u2019\u00e9tude de validation de principe en cours pour la mise \u00e0 jour des annexes du guideline ICH Q4B. Le GDP a ainsi examin\u00e9 et actualis\u00e9 le guideline ICH Q4B et l\u2019annexe 5 de la proc\u00e9dure op\u00e9ratoire standardis\u00e9e des groupes de travail de l\u2019ICH, qu\u2019il a ensuite pr\u00e9sent\u00e9s, en novembre, lors de la r\u00e9union de l\u2019ICH qui s\u2019est tenue \u00e0 Prague. D\u2019apr\u00e8s les commentaires re\u00e7us, des ajustements s\u2019av\u00e8rent n\u00e9cessaires et seront mis en place courant 2024.<\/p><p>Les pharmacop\u00e9es du GDP ont, \u00e0 ce jour, harmonis\u00e9 30 des 31 chapitres g\u00e9n\u00e9raux et 48 des 62 monographies d\u2019excipients figurant au programme de travail du groupe.<\/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-9b6c4fd elementor-section-stretched animated-slow elementor-section-boxed elementor-section-height-default elementor-section-height-default elementor-invisible\" data-id=\"9b6c4fd\" 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-54b28f4\" data-id=\"54b28f4\" 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-465d531 elementor-widget elementor-widget-heading\" data-id=\"465d531\" 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\">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-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\">Drogues v\u00e9g\u00e9tales et pr\u00e9parations \u00e0 base de drogues v\u00e9g\u00e9tales<\/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-7ba9aa4 elementor-widget elementor-widget-text-editor\" data-id=\"7ba9aa4\" 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>Lors de sa 175<sup>e<\/sup>\u00a0session (mars 2023), l\u2019EPC a approuv\u00e9 la deuxi\u00e8me \u00e9dition du <a href=\"https:\/\/www.edqm.eu\/fr\/-\/edqm-publishes-2nd-edition-of-herbal-guide\" target=\"_blank\" rel=\"noopener\"><em><span style=\"text-decoration: underline;\">Guide pour l\u2019\u00e9laboration des monographies de drogues v\u00e9g\u00e9tales et pr\u00e9parations \u00e0 base de drogues v\u00e9g\u00e9tales<\/span><\/em><\/a> , qui constitue une aide pr\u00e9cieuse pour les personnes charg\u00e9es de r\u00e9diger des monographies couvrant ce type de substances. Il permet, par ailleurs, aux utilisateurs et utilisatrices de la Ph. Eur. de comprendre les principes d\u2019\u00e9laboration et de r\u00e9vision des monographies de drogues v\u00e9g\u00e9tales. La publication de la premi\u00e8re \u00e9dition remontant \u00e0 2005, une r\u00e9vision approfondie du texte s\u2019imposait pour int\u00e9grer les progr\u00e8s techniques et les nouvelles politiques adopt\u00e9es depuis lors. Tout comme d\u2019autres guides techniques de la Ph. Eur. \u2013 ressources utiles traitant de th\u00e8mes vari\u00e9s \u2013, cet ouvrage est disponible sur la <span style=\"text-decoration: underline;\"><a href=\"https:\/\/www.edqm.eu\/fr\/ph-eur-technical-guides\" target=\"_blank\" rel=\"noopener\">page du site web de l\u2019EDQM pr\u00e9vue \u00e0 cet effet<\/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<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 no-margin 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\">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-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>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. Elle comprend \u00e9galement une section Mapped terms, 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, et des services web (\u00e9galement appel\u00e9s \u00ab interfaces de programmation \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>\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-c6c7e02 elementor-widget elementor-widget-image\" data-id=\"c6c7e02\" 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=\"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\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\" 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Eur. monographs The European Network of Official Medicines Control Laboratories The EDQM&#8217;s response to nitrosamine contamination Anti-falsification activities Pharmaceuticals and pharmaceutical care European Pediatric Formulary The European Pharmacopoeia The European Pharmacopoeia (Ph. Eur.) is a single reference [&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-345","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 Pharmacopoeia | 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\/the-european-pharmacopoeia\/\" \/>\n<meta property=\"og:locale\" content=\"fr_FR\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"The European Pharmacopoeia | Quality &amp; use of medicines - EDQM\" \/>\n<meta property=\"og:description\" content=\"Quality &#038; use of medicines Quick links The European Pharmacopoeia Reference standards Certification of suitability to the Ph. 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