{"id":5387,"date":"2026-05-27T15:00:08","date_gmt":"2026-05-27T15:00:08","guid":{"rendered":"http:\/\/annualreport.edqm.eu\/?page_id=5387"},"modified":"2026-06-19T05:00:11","modified_gmt":"2026-06-19T05:00:11","slug":"edqm-initiatives-on-medicine-shortages","status":"publish","type":"page","link":"https:\/\/annualreport.edqm.eu\/en\/edqm-initiatives-on-medicine-shortages\/","title":{"rendered":"EDQM initiatives on medicine shortages"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-page\" data-elementor-id=\"5387\" class=\"elementor elementor-5387\" data-elementor-post-type=\"page\">\n\t\t\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-7562bc42 elementor-section-height-min-height elementor-section-stretched elementor-section-boxed elementor-section-height-default elementor-section-items-middle elementor-invisible\" data-id=\"7562bc42\" 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-fdad170\" data-id=\"fdad170\" 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-28a07516 elementor-widget elementor-widget-heading\" data-id=\"28a07516\" 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<h1 class=\"elementor-heading-title elementor-size-default\">Tackling public health challenges<\/h1>\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-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-fb2fe31\" data-id=\"fb2fe31\" 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-b942010 elementor-widget elementor-widget-heading\" data-id=\"b942010\" 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<h1 class=\"elementor-heading-title elementor-size-default\">EDQM initiatives on medicine shortages<\/h1>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-8911b14 elementor-widget elementor-widget-text-editor\" data-id=\"8911b14\" 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><strong>Medicine shortages continue to place a strain on healthcare systems across Europe, affecting patient care and driving up costs. Although not a new challenge, the problem has intensified in recent years due to the COVID\u201119 pandemic and geopolitical instability, exposing weaknesses across the pharmaceutical supply chain and underscoring the need for stronger co\u2011ordinated responses.<\/strong><\/p><p><strong>Hospital and community pharmacists are at the forefront of efforts to mitigate the impact of these shortages, notably by preparing extemporaneous and stock preparations when authorised products are unavailable. In this context, the European Committee on Pharmaceuticals and Pharmaceutical Care (CD-P-PH) and the EPC have initiated two complementary projects, aligned with other international efforts, to help ensure the continued availability of safe pharmaceutical preparations of appropriate quality.<\/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\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-e04a210 elementor-section-stretched animated-slow elementor-section-boxed elementor-section-height-default elementor-section-height-default elementor-invisible\" data-id=\"e04a210\" data-element_type=\"section\" data-e-type=\"section\" data-settings=\"{&quot;stretch_section&quot;:&quot;section-stretched&quot;,&quot;animation&quot;:&quot;fadeIn&quot;,&quot;background_background&quot;:&quot;classic&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-bcb4b30 wl-expand-block\" data-id=\"bcb4b30\" 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-81099d7 elementor-widget elementor-widget-heading\" data-id=\"81099d7\" 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\">EDQM tackles medicine shortages<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-6e5e7f3 elementor-widget elementor-widget-image\" data-id=\"6e5e7f3\" 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=\"870\" height=\"489\" src=\"https:\/\/annualreport.edqm.eu\/wp-content\/uploads\/2026\/05\/European-Drug-Shortages-Formulary-blisters.jpg\" class=\"attachment-full size-full wp-image-5389\" alt=\"\" srcset=\"https:\/\/annualreport.edqm.eu\/wp-content\/uploads\/2026\/05\/European-Drug-Shortages-Formulary-blisters.jpg 870w, https:\/\/annualreport.edqm.eu\/wp-content\/uploads\/2026\/05\/European-Drug-Shortages-Formulary-blisters-300x169.jpg 300w, https:\/\/annualreport.edqm.eu\/wp-content\/uploads\/2026\/05\/European-Drug-Shortages-Formulary-blisters-768x432.jpg 768w, https:\/\/annualreport.edqm.eu\/wp-content\/uploads\/2026\/05\/European-Drug-Shortages-Formulary-blisters-18x10.jpg 18w, https:\/\/annualreport.edqm.eu\/wp-content\/uploads\/2026\/05\/European-Drug-Shortages-Formulary-blisters-800x450.jpg 800w\" 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<div class=\"elementor-element elementor-element-ed536a7 elementor-widget elementor-widget-text-editor\" data-id=\"ed536a7\" 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><em><strong>The EDQM is leading three complementary initiatives to help authorities and pharmacists anticipate, manage and mitigate medicine shortages with safe, quality\u2011assured alternatives.<\/strong><\/em><\/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-1a69069 wl-expand-content elementor-widget elementor-widget-text-editor\" data-id=\"1a69069\" 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>The <em>Methodological guide to select medicines at risk of shortages<\/em> aims to equip national competent authorities and hospital and community pharmacists with a structured approach for identifying medicines that could become scarce during public health emergencies. Once finalised, the guide will support strategic planning by helping determine which products can be safely prepared in pharmacies when industrially manufactured medicines are unavailable.<\/p><p>To provide practical tools during active shortages, the EDQM has also set up the European Drug Shortages Formulary (EDSForm). Its monographs offer standardised methods for preparing and controlling unlicensed pharmaceutical preparations that can temporarily replace essential medicines. This long-term, proactive resource is complemented by technical recommendations from the EDSForm Working Party (EDSForm WP), providing short-term, reactive guidance for preparing extemporaneous or stock formulations when no EDSForm monograph exists.<\/p><p><span class=\"TextRun  BCX8 SCXO123484882\" lang=\"EN-GB\" xml:lang=\"EN-GB\" data-contrast=\"auto\"><span class=\"NormalTextRun  BCX8 SCXO123484882\">When a shortage is caused by limited availability of an active pharmaceutical ingredient (API), the EDQM aims to support stakeholders by considering requests for fast-track assessment of CEP applications and revisions. Eligibility requirements are described in the associated EDQM guideline \u201c<a href=\"https:\/\/www.edqm.eu\/documents\/52006\/107691\/PA+PH+CEP+%2826%29+05.pdf\/4e1eefe3-dcdb-4e2d-84cf-78da08436828?t=1773400082237\" target=\"_blank\" rel=\"noopener\">Guidance on requesting fast-track assessment of CEP applications, revisions and renewals<\/a>\u201d.<\/span><\/span><\/p><p>Together, these initiatives strengthen Europe\u2019s capacity to prevent, plan for and alleviate the impact of medicine shortages.<\/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-92046df wl-expand-toggle elementor-widget elementor-widget-button\" data-id=\"92046df\" 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-size-sm\" role=\"button\">\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\">Read more<\/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-fee6497 elementor-section-stretched animated-slow elementor-section-boxed elementor-section-height-default elementor-section-height-default elementor-invisible\" data-id=\"fee6497\" data-element_type=\"section\" data-e-type=\"section\" data-settings=\"{&quot;stretch_section&quot;:&quot;section-stretched&quot;,&quot;animation&quot;:&quot;fadeIn&quot;,&quot;background_background&quot;:&quot;classic&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-d26192c wl-expand-block\" data-id=\"d26192c\" 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-345529c elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"345529c\" 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-5ce012f wl-expand-block\" data-id=\"5ce012f\" 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-e6b6213 elementor-widget elementor-widget-heading\" data-id=\"e6b6213\" 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\">European Drug Shortages Formulary takes shape: EDQM publishes first EDSForm texts for public consultation<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-781c279 news-card-image elementor-widget elementor-widget-image\" data-id=\"781c279\" 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 decoding=\"async\" width=\"870\" height=\"489\" src=\"https:\/\/annualreport.edqm.eu\/wp-content\/uploads\/2026\/05\/runner.jpg\" class=\"attachment-full size-full wp-image-5390\" alt=\"\" srcset=\"https:\/\/annualreport.edqm.eu\/wp-content\/uploads\/2026\/05\/runner.jpg 870w, https:\/\/annualreport.edqm.eu\/wp-content\/uploads\/2026\/05\/runner-300x169.jpg 300w, https:\/\/annualreport.edqm.eu\/wp-content\/uploads\/2026\/05\/runner-768x432.jpg 768w, https:\/\/annualreport.edqm.eu\/wp-content\/uploads\/2026\/05\/runner-18x10.jpg 18w, https:\/\/annualreport.edqm.eu\/wp-content\/uploads\/2026\/05\/runner-800x450.jpg 800w\" 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<div class=\"elementor-element elementor-element-3cc38f4 elementor-widget elementor-widget-text-editor\" data-id=\"3cc38f4\" 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><em><strong>The EDQM announced the opening for public consultation of the first three texts of the European Drug Shortages Formulary, its second formulary after PaedForm.<\/strong><\/em><\/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-4abf66f wl-expand-content elementor-widget elementor-widget-text-editor\" data-id=\"4abf66f\" 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>The EDQM released the first three texts for consultation in the <span style=\"color: #ffffff;\"><a style=\"color: #ffffff;\" href=\"https:\/\/edsform.edqm.eu\/home\" target=\"_blank\" rel=\"noopener\">European Drug Shortages Formulary<\/a><\/span> (EDSForm), inviting healthcare professionals and interested parties across Europe to provide feedback on two general texts intended to help users navigate the content and concepts laid down in the formulary \u2013 <em>Introduction to the European Drug Shortages Formulary<\/em> and <em>General principles of the European Drug Shortages Formulary<\/em> \u2013 and on the draft <em>Amoxicillin capsules<\/em> monograph. These first texts were finalised only a few months after their addition to EDSForm WP\u2019s work programme in November 2024. The commenting deadline was 31\u00a0December 2025, and were published in April 2026 on the same platform.<\/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-daeb78a wl-expand-toggle elementor-widget elementor-widget-button\" data-id=\"daeb78a\" 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-size-sm\" role=\"button\">\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\">Read more<\/span>\n\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/a>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t<div class=\"elementor-column elementor-col-50 elementor-inner-column elementor-element elementor-element-d89284c wl-expand-block\" data-id=\"d89284c\" 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-7ffafef elementor-widget elementor-widget-heading\" data-id=\"7ffafef\" 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\">Technical recommendation of the EDSForm WP: sulfamethoxazole-trimethoprim, paediatric products<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-3f6a4e4 news-card-image elementor-widget elementor-widget-image\" data-id=\"3f6a4e4\" 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 decoding=\"async\" width=\"870\" height=\"489\" src=\"https:\/\/annualreport.edqm.eu\/wp-content\/uploads\/2026\/05\/baby01.jpg\" class=\"attachment-full size-full wp-image-5392\" alt=\"\" srcset=\"https:\/\/annualreport.edqm.eu\/wp-content\/uploads\/2026\/05\/baby01.jpg 870w, https:\/\/annualreport.edqm.eu\/wp-content\/uploads\/2026\/05\/baby01-300x169.jpg 300w, https:\/\/annualreport.edqm.eu\/wp-content\/uploads\/2026\/05\/baby01-768x432.jpg 768w, https:\/\/annualreport.edqm.eu\/wp-content\/uploads\/2026\/05\/baby01-18x10.jpg 18w, https:\/\/annualreport.edqm.eu\/wp-content\/uploads\/2026\/05\/baby01-800x450.jpg 800w\" 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<div class=\"elementor-element elementor-element-a31d3f6 elementor-widget elementor-widget-text-editor\" data-id=\"a31d3f6\" 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><em><strong>Recurring shortages of paediatric co\u2011trimoxazole prompted the EDSForm WP to issue technical recommendations, outlining available unlicensed oral formulations to support healthcare professionals during temporary disruptions.<\/strong><\/em><\/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-215256a wl-expand-content elementor-widget elementor-widget-text-editor\" data-id=\"215256a\" 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>Sulfamethoxazole-trimethoprim (also known as co-trimoxazole) is a fixed-dose combination of two antibiotics used to treat a number of bacterial infections, which several member states had reported recurring difficulties in procuring. Paediatric forms were especially affected, prompting the EDSForm WP to compile existing knowledge on extemporaneous or stock oral formulations of sulfamethoxazole-trimethoprim used to alleviate the lack of age-appropriate licensed products.<\/p><p>The information provided in the resulting <span style=\"color: #ffffff;\"><a style=\"color: #ffffff;\" href=\"https:\/\/www.edqm.eu\/documents\/52006\/286634\/Technical%20recommendation%20Sulfamethoxazole-trimethoprim%20ENG.pdf\/7002c7ae-38c6-38aa-9f1c-d71ae5e71f66?t=1744726232743\" target=\"_blank\" rel=\"noopener\">technical recommendation<\/a><\/span> was published to help healthcare professionals in their risk-assessment and decision-making processes on how to best treat their paediatric patients when faced with the temporary unavailability of a suitable formulation of this product. The recommendation addressed general considerations on unlicensed pharmaceutical preparations containing sulfamethoxazole-trimethoprim and included nine oral suspensions, one of which, shared directly with the EDSForm WP, could be suitable for large-batch preparations and was backed by relevant stability data.<\/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-70dd489 wl-expand-toggle elementor-widget elementor-widget-button\" data-id=\"70dd489\" 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-size-sm\" role=\"button\">\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\">Read more<\/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\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-31539fc elementor-section-stretched animated-slow elementor-section-boxed elementor-section-height-default elementor-section-height-default elementor-invisible\" data-id=\"31539fc\" 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-73140da wl-expand-block\" data-id=\"73140da\" 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-4f9c124 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"4f9c124\" 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-5393915 wl-expand-block\" data-id=\"5393915\" 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-24c55cc elementor-widget elementor-widget-heading\" data-id=\"24c55cc\" 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\">Technical recommendation of the EDSForm WP: clarithromycin, paediatric products<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-23dd438 news-card-image elementor-widget elementor-widget-image\" data-id=\"23dd438\" 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 loading=\"lazy\" decoding=\"async\" width=\"870\" height=\"489\" src=\"https:\/\/annualreport.edqm.eu\/wp-content\/uploads\/2026\/05\/Girl_Cough.jpg\" class=\"attachment-full size-full wp-image-5393\" alt=\"\" srcset=\"https:\/\/annualreport.edqm.eu\/wp-content\/uploads\/2026\/05\/Girl_Cough.jpg 870w, https:\/\/annualreport.edqm.eu\/wp-content\/uploads\/2026\/05\/Girl_Cough-300x169.jpg 300w, https:\/\/annualreport.edqm.eu\/wp-content\/uploads\/2026\/05\/Girl_Cough-768x432.jpg 768w, https:\/\/annualreport.edqm.eu\/wp-content\/uploads\/2026\/05\/Girl_Cough-18x10.jpg 18w, https:\/\/annualreport.edqm.eu\/wp-content\/uploads\/2026\/05\/Girl_Cough-800x450.jpg 800w\" 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<div class=\"elementor-element elementor-element-9295a7b elementor-widget elementor-widget-text-editor\" data-id=\"9295a7b\" 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><em><strong>Major shortages of paediatric clarithromycin led the EDQM and the EDSForm WP to compile limited existing data into technical recommendations, including three unlicensed formulations to support healthcare professionals during supply disruptions.<\/strong><\/em><\/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-5b0e5a3 wl-expand-content elementor-widget elementor-widget-text-editor\" data-id=\"5b0e5a3\" 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>Clarithromycin is a macrolide antibiotic widely used to treat a number of infections. With major shortages of clarithromycin-containing products \u2013 especially paediatric forms (e.g. granules for oral suspension) \u2013 being reported in several member states, the EDSForm WP conducted a bibliographical review. It highlighted the relative scarcity of existing knowledge on extemporaneous or stock oral formulations of clarithromycin used to alleviate the lack of age-appropriate licensed products containing clarithromycin.<\/p><p>The experts of the EDSForm WP compiled the available information in a <a href=\"https:\/\/www.edqm.eu\/documents\/52006\/1912832\/TECHNICAL%20RECOMMENDATIONS_Clarithromycin%20vRM.pdf\/9e5d8275-bf29-9a99-4b33-c40fc47d873a?t=1753968509207\" target=\"_blank\" rel=\"noopener\">technical recommendation<\/a> intended to help healthcare professionals in their risk-assessment and decision-making processes. It contains technical considerations on the production of unlicensed pharmaceutical preparations containing clarithromycin, as well as three formulations, one of which was shared by the French National Agency for Medicines and Health Products Safety (ANSM). In view of the existing data, they considered that additional development of an appropriate formulation for the production of extemporaneous or stock preparations might be necessary.<\/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-f980f30 wl-expand-toggle elementor-widget elementor-widget-button\" data-id=\"f980f30\" 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-size-sm\" role=\"button\">\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\">Read more<\/span>\n\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/a>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t<div class=\"elementor-column elementor-col-50 elementor-inner-column elementor-element elementor-element-3480a8e wl-expand-block\" data-id=\"3480a8e\" 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-3626c1f elementor-widget elementor-widget-heading\" data-id=\"3626c1f\" 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\">Regulatory reliance and fast-track assessment in the CEP procedure<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-001b95b news-card-image elementor-widget elementor-widget-image\" data-id=\"001b95b\" 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 loading=\"lazy\" decoding=\"async\" width=\"870\" height=\"489\" src=\"https:\/\/annualreport.edqm.eu\/wp-content\/uploads\/2026\/05\/News-155.png\" class=\"attachment-full size-full wp-image-5394\" alt=\"\" srcset=\"https:\/\/annualreport.edqm.eu\/wp-content\/uploads\/2026\/05\/News-155.png 870w, https:\/\/annualreport.edqm.eu\/wp-content\/uploads\/2026\/05\/News-155-300x169.png 300w, https:\/\/annualreport.edqm.eu\/wp-content\/uploads\/2026\/05\/News-155-768x432.png 768w, https:\/\/annualreport.edqm.eu\/wp-content\/uploads\/2026\/05\/News-155-18x10.png 18w, https:\/\/annualreport.edqm.eu\/wp-content\/uploads\/2026\/05\/News-155-800x450.png 800w\" 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<div class=\"elementor-element elementor-element-0028773 elementor-widget elementor-widget-text-editor\" data-id=\"0028773\" 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><em><strong>The EDQM is strengthening regulatory efficiency through good reliance practices and introducing fast\u2011track Certificate of Suitability (CEP) assessments to support timely access to critical substances and help mitigate the risks of medicine shortages.<\/strong><\/em><\/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-cdc4934 wl-expand-content elementor-widget elementor-widget-text-editor\" data-id=\"cdc4934\" 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>Regulatory reliance, as defined by WHO, is rooted in good regulatory practices that strengthen the efficiency, consistency and effectiveness of medicines regulation. Many authorities are increasingly adopting reliance principles in their assessment processes. The EDQM applies this approach within the CEP procedure, particularly for new applications and sister files, to facilitate timely access to safe, effective and quality\u2011assured active substances while optimising regulatory resources.<\/p><p>To date, reliance-based assessments have focused primarily on applications where applicants have declared the use of an appropriate Active Substance Master File (ASMF) or Drug Master File (DMF). The EDQM is also exploring additional routes to expand reliance approaches and encourages applicants to include relevant, supportive information in their submissions.<\/p><p>Importantly, and in alignment with the <a href=\"https:\/\/health.ec.europa.eu\/medicinal-products\/legal-framework-governing-medicinal-products-human-use-eu\/critical-medicines-act_en\" target=\"_blank\" rel=\"noopener\">EU Critical Medicines Act<\/a>, the EDQM is introducing the possibility of fast\u2011track treatment for certain CEP applications or revisions. This measure is intended for justified cases where accelerated assessment could help prevent or mitigate shortages of pharmaceutical substances, thereby supporting continuity of supply for critical medicines. A dedicated mechanism is being put in place to allow applicants to request fast\u2011tracked treatment when needed.<\/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-2234ad4 wl-expand-toggle elementor-widget elementor-widget-button\" data-id=\"2234ad4\" 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-size-sm\" role=\"button\">\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\">Read more<\/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\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-45d81fb elementor-section-stretched animated-slow elementor-section-boxed elementor-section-height-default elementor-section-height-default elementor-invisible\" data-id=\"45d81fb\" data-element_type=\"section\" data-e-type=\"section\" data-settings=\"{&quot;stretch_section&quot;:&quot;section-stretched&quot;,&quot;animation&quot;:&quot;fadeIn&quot;,&quot;background_background&quot;:&quot;classic&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-b74bfff wl-expand-block\" data-id=\"b74bfff\" 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-42d7efa elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"42d7efa\" 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-9c66cfe wl-expand-block\" data-id=\"9c66cfe\" 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-df18c70 elementor-widget elementor-widget-heading\" data-id=\"df18c70\" 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\">EDQM Stakeholder Event - Plasma Supply Continuity<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-c0553f0 news-card-image elementor-widget elementor-widget-image\" data-id=\"c0553f0\" 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 loading=\"lazy\" decoding=\"async\" width=\"870\" height=\"469\" src=\"https:\/\/annualreport.edqm.eu\/wp-content\/uploads\/2026\/06\/Plasma.jpg\" class=\"attachment-full size-full wp-image-5901\" alt=\"\" srcset=\"https:\/\/annualreport.edqm.eu\/wp-content\/uploads\/2026\/06\/Plasma.jpg 870w, https:\/\/annualreport.edqm.eu\/wp-content\/uploads\/2026\/06\/Plasma-300x162.jpg 300w, https:\/\/annualreport.edqm.eu\/wp-content\/uploads\/2026\/06\/Plasma-768x414.jpg 768w, https:\/\/annualreport.edqm.eu\/wp-content\/uploads\/2026\/06\/Plasma-18x10.jpg 18w\" 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<div class=\"elementor-element elementor-element-b7c5a95 elementor-widget elementor-widget-text-editor\" data-id=\"b7c5a95\" 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><em><strong>This stakeholder event highlighted strategies to increase the safe collection and adequate supply of plasma and plasma-derived medicinal products (PDMPs), building upon recent and ongoing initiatives in Europe.<\/strong><\/em><\/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-f4f75be wl-expand-content elementor-widget elementor-widget-text-editor\" data-id=\"f4f75be\" 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>This event provided an update on the latest developments in plasma supply in Europe, along with strategies to enhance and increase the safe collection and adequate supply of plasma and PDMPs.<\/p><p>It covered the entire plasma-to-PDMP-to-patient chain as part of a continuous effort to build upon recent and ongoing initiatives aimed at increasing and improving plasma collection and PDMP supply in European countries, and in the context of the changing regulatory landscape in the EU.<\/p><p>The EDQM, an essential partner for blood establishments in Europe and beyond, is a major contributor to developing internationally recognised guidelines and providing capacity-building tools. In collaboration with international experts, the EDQM actively supports progress in the \ufb01eld of SoHO by organising dedicated conferences and providing regular training courses on quality management.<\/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-728a5f4 wl-expand-toggle elementor-widget elementor-widget-button\" data-id=\"728a5f4\" 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-size-sm\" role=\"button\">\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\">Read more<\/span>\n\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/a>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t<div class=\"elementor-column elementor-col-50 elementor-inner-column elementor-element elementor-element-e5a358b wl-expand-block\" data-id=\"e5a358b\" 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-7246fff elementor-widget elementor-widget-heading\" data-id=\"7246fff\" 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\">Anti-D immunoglobulin: CD-P-TS targeted initiatives to strengthen European supply<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-350c3ca news-card-image elementor-widget elementor-widget-image\" data-id=\"350c3ca\" 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 loading=\"lazy\" decoding=\"async\" width=\"870\" height=\"489\" src=\"https:\/\/annualreport.edqm.eu\/wp-content\/uploads\/2026\/05\/tablet-anti-d-immunoglobulin-report.jpg\" class=\"attachment-full size-full wp-image-5396\" alt=\"\" srcset=\"https:\/\/annualreport.edqm.eu\/wp-content\/uploads\/2026\/05\/tablet-anti-d-immunoglobulin-report.jpg 870w, https:\/\/annualreport.edqm.eu\/wp-content\/uploads\/2026\/05\/tablet-anti-d-immunoglobulin-report-300x169.jpg 300w, https:\/\/annualreport.edqm.eu\/wp-content\/uploads\/2026\/05\/tablet-anti-d-immunoglobulin-report-768x432.jpg 768w, https:\/\/annualreport.edqm.eu\/wp-content\/uploads\/2026\/05\/tablet-anti-d-immunoglobulin-report-18x10.jpg 18w, https:\/\/annualreport.edqm.eu\/wp-content\/uploads\/2026\/05\/tablet-anti-d-immunoglobulin-report-800x450.jpg 800w\" 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<div class=\"elementor-element elementor-element-856ebd7 elementor-widget elementor-widget-text-editor\" data-id=\"856ebd7\" 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><em><strong>Through sustained technical and policy actions since 2010, the CD\u2011P\u2011TS has helped address vulnerabilities in Europe\u2019s anti\u2011D IgG supply, supporting resilient, sustainable plasma collection and shortage prevention.<\/strong><\/em><\/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-e2020cd wl-expand-content elementor-widget elementor-widget-text-editor\" data-id=\"e2020cd\" 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>Over the past decade, the CD\u2011P\u2011TS, co-ordinated by the EDQM, has led and supported a series of initiatives aimed at strengthening the resilience and sustainability of Europe\u2019s anti\u2011D immunoglobulin (IgG) supply. These efforts have addressed long\u2011standing structural weaknesses, notably Europe\u2019s near\u2011total reliance on anti\u2011D plasma collected in the United States and the associated risks of supply disruption and shortages.<\/p><p>The CD\u2011P\u2011TS first examined this issue in 2010 through a position paper on the development of monoclonal anti\u2011D antibodies, followed in 2014 by a comprehensive report on anti\u2011D alloimmunisation, immunoprophylaxis practices and European self\u2011sufficiency. Building on this foundation, a dedicated working group on anti\u2011D IgG was established in 2023 to raise awareness of the lack of anti\u2011D plasma collection in Europe and to identify actions needed to improve supply sufficiency.<\/p><p>The working group promoted international co-operation on plasma collection, explored donor immunisation strategies, examined manufacturing and access challenges for polyclonal anti\u2011D IgG, and assessed the potential of alternative or complementary therapies. As part of this work, the EDQM hosted a webinar series in autumn 2023, which helped mobilise stakeholders and laid the groundwork for co-ordinated international action.<\/p><p>In October 2024, a joint CD\u2011P\u2011TS\u2013European Blood Alliance survey gathered data on the feasibility of initiating or resuming anti\u2011D plasma collection across Europe. In parallel, recommendations issued in 2025 by the EMA and the Heads of Medicines Agencies highlighted persistent vulnerabilities in the anti\u2011D IgG supply chain.<\/p><p>The resulting technical report, drafted in 2025, consolidated these initiatives, complemented regulatory recommendations and provided scientific, technical and operational guidance to support sustainable European anti\u2011D plasma collection programmes, strengthening supply continuity and reducing the risk of shortages.<\/p><p>Find out more on the dedicated EDQM web page: <a href=\"https:\/\/www.edqm.eu\/en\/anti-d-immunoglobulin\" target=\"_blank\" rel=\"noopener\">Anti-D immunoglobulin: CD-P-TS targeted initiatives to strengthen European supply<\/a>.<\/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-87fba42 wl-expand-toggle elementor-widget elementor-widget-button\" data-id=\"87fba42\" data-element_type=\"widget\" data-e-type=\"widget\" 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Although not a new challenge, the problem has intensified in recent years due to the COVID\u201119 pandemic and geopolitical instability, exposing [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_acf_changed":false,"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-5387","page","type-page","status-publish","hentry","entry"],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v27.9 (Yoast SEO v27.9) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>EDQM initiatives on medicine shortages - 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:\/\/annualreport.edqm.eu\/en\/edqm-initiatives-on-medicine-shortages\/\" \/>\n<meta property=\"og:locale\" content=\"en_GB\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"EDQM initiatives on medicine shortages\" \/>\n<meta property=\"og:description\" content=\"Tackling public health challenges R\u00e9pondre aux enjeux de sant\u00e9 publique EDQM initiatives on medicine shortages Medicine shortages continue to place a strain on healthcare systems across Europe, affecting patient care and driving up costs. 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