{"id":5299,"date":"2026-05-27T11:22:47","date_gmt":"2026-05-27T11:22:47","guid":{"rendered":"http:\/\/annualreport.edqm.eu\/?page_id=5299"},"modified":"2026-06-30T21:37:08","modified_gmt":"2026-06-30T21:37:08","slug":"tackling-public-health-challenges","status":"publish","type":"page","link":"https:\/\/annualreport.edqm.eu\/en\/tackling-public-health-challenges\/","title":{"rendered":"Tackling public health challenges"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-page\" data-elementor-id=\"5299\" class=\"elementor elementor-5299\" data-elementor-post-type=\"page\">\n\t\t\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-69d5082 elementor-section-height-min-height elementor-section-stretched elementor-section-boxed elementor-section-height-default elementor-section-items-middle elementor-invisible\" data-id=\"69d5082\" 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-ae825ee\" data-id=\"ae825ee\" 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-05ab45b elementor-widget elementor-widget-heading\" data-id=\"05ab45b\" 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-8911b14 elementor-widget elementor-widget-text-editor\" data-id=\"8911b14\" 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><strong>Responding to evolving public health challenges requires agility, scientific rigour and close engagement with stakeholders. Throughout 2025, the European Directorate for the Quality of Medicines &amp; HealthCare (EDQM) advanced work across its core domains to address emerging needs and support the safety, quality and accessibility of medicines and health products. This section highlights key achievements related to the European Pharmacopoeia (Ph. Eur.), initiatives addressing medicine shortages and activities in the field of substances of human origin (SoHO).<\/strong><\/p><p><strong>As science and technology advance at an unprecedented pace, standards must remain relevant and future\u2011proof. The Ph. Eur. continues to modernise its texts, integrating animal-free testing alternatives, state\u2011of\u2011the\u2011art analytical methods and new requirements for innovative products, such as messenger ribonucleic acid (mRNA) vaccines, advanced therapies and complex biologicals. This ongoing work strengthens harmonised quality standards, reinforces trust in medicines and supports healthcare systems in delivering safe and effective treatments.<\/strong><\/p><p><strong>In 2025, medicine shortages remained a significant concern for many countries. Drawing on expertise across its programmes, the EDQM contributed to initiatives to improve supply resilience by enhancing transparency and strengthening co-ordination between authorities, laboratories and manufacturers. This collaborative work is increasingly vital to anticipate disruptions, tackle shortages proactively and ensure that patients continue to receive the treatments they need.<\/strong><\/p><p><strong>In parallel, activities related to SoHO \u2013 blood, tissues, cells and organs \u2013 continued to reinforce safety and quality frameworks for therapies that rely on these substances. Through standard\u2011setting, guidance and expert collaboration, the EDQM helped national authorities to anticipate risks and support safe clinical use in a rapidly changing landscape.<\/strong><\/p><p><strong>Together, these initiatives reflect the EDQM\u2019s commitment to anticipating developments, mobilising expert networks and delivering solutions that protect public health throughout Europe and beyond.<\/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-2298d59 elementor-section-stretched animated-slow elementor-section-boxed elementor-section-height-default elementor-section-height-default elementor-invisible\" data-id=\"2298d59\" data-element_type=\"section\" data-e-type=\"section\" id=\"europeanpharmacopoeia\" 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-03dfca0\" data-id=\"03dfca0\" 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-95f0068 elementor-widget elementor-widget-heading\" data-id=\"95f0068\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">The European Pharmacopoeia \u2013 Advancements throughout the year<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-7fd78dc elementor-widget elementor-widget-text-editor\" data-id=\"7fd78dc\" 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>The Ph. Eur. is the cornerstone for the quality control of medicines in the 39 member states that have ratified the Convention on the Elaboration of a European Pharmacopoeia. By setting harmonised quality standards, the Ph. Eur. plays a vital role in protecting public health, providing a legal and scientific framework for the quality control of medicines and their components \u2013 from development through to production and marketing. These standards are legally binding for all manufacturers seeking to market their products in the Ph. Eur. member states. As global medicine production evolves, the Ph. Eur. has gained recognition far beyond Europe. Its standards help shape international quality benchmarks for medicines and support worldwide efforts to align and harmonise quality requirements, thus promoting the safe and effective use of medicinal products globally.<\/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;}\" 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\">Swan song for general animal safety tests: another significant milestone in the elimination of animal tests from the Ph. Eur.<\/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\/03\/Cavia-porcellus-guinea-pig.jpg\" class=\"attachment-full size-full wp-image-5142\" alt=\"Swan song for general animal safety tests\" srcset=\"https:\/\/annualreport.edqm.eu\/wp-content\/uploads\/2026\/03\/Cavia-porcellus-guinea-pig.jpg 870w, https:\/\/annualreport.edqm.eu\/wp-content\/uploads\/2026\/03\/Cavia-porcellus-guinea-pig-300x169.jpg 300w, https:\/\/annualreport.edqm.eu\/wp-content\/uploads\/2026\/03\/Cavia-porcellus-guinea-pig-768x432.jpg 768w, https:\/\/annualreport.edqm.eu\/wp-content\/uploads\/2026\/03\/Cavia-porcellus-guinea-pig-18x10.jpg 18w, https:\/\/annualreport.edqm.eu\/wp-content\/uploads\/2026\/03\/Cavia-porcellus-guinea-pig-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 European Pharmacopoeia Commission (EPC) decided to remove several long-standing safety tests requiring animals (for pyrogens, histamine and\u00a0 depressor substances), marking the end of general animal safety testing in the Ph. Eur. as of 1 January 2026.<\/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>At its 180th session in November 2024, the EPC decided to suppress the general chapters on <em>Pyrogens\u00a0(2.6.8)<\/em>, <em>Histamine\u00a0(2.6.10)<\/em> and <em>Depressor substances (2.6.11) \u2013<\/em> all of which required the use of animals \u2013 starting with the 12th Edition of the Ph. Eur. Fourteen monographs were also scheduled for revision to delete references to the histamine chapter or requirements associated with depressor substances.<\/p><p>These tests had been part of the Ph. Eur. since its first edition (1969) and were used to ensure the safety of parenteral medicines before the advent of modern analytical techniques and good manufacturing practice. Their removal aligns with the <a href=\"https:\/\/www.coe.int\/en\/web\/conventions\/full-list?module=treaty-detail&amp;treatynum=123\" target=\"_blank\" rel=\"noopener\">European Convention for the Protection of Vertebrate Animals Used for Experimental and other Scientific Purposes<\/a>, and represents a major step in the EPC\u2019s long\u2011standing work to implement the 3R principles (to replace, reduce and refine the use of animals in scientific procedures). Together with the <a href=\"https:\/\/www.edqm.eu\/documents\/52006\/86463\/Press+release+-+Suppression+Test+Abnormal+Toxicity+Ph.Eur.+-+December+2017.pdf\/074c1834-cb1a-6355-9ade-96f33a63e653?t=1636119718984\" target=\"_blank\" rel=\"noopener\">suppression of the Ph. Eur. general chapter on <em>Abnormal<\/em> <em>toxicity (2.6.9)<\/em><\/a> in 2017, this decision marks the end of general animal safety testing in the Ph. Eur., effective 1 January 2026.<\/p><p>The suppression of <em>Pyrogens\u00a0 (2.6.8)<\/em> follows the adoption of 57 revised texts from which the rabbit pyrogen test had been deleted and the introduction of a new general chapter, <em>Pyrogenicity (5.1.13)<\/em>\u00a0in the Ph. Eur. For <em>Histamine (2.6.10)<\/em> and <em>Depressor substances (2.6.11)<\/em>, which involved guinea pigs and cats respectively, a detailed strategy for their deletion was agreed at the 177th EPC session in 2023. Further background on this approach is provided in the strategy document \u201c<a href=\"https:\/\/pbiosn.edqm.eu\/app\/pbiosn\/content\/default\/2024-2_Removal_of_animal_tests_for_histamine_and_depressor_substances.pdf\" target=\"_blank\" rel=\"noopener\">Ph.\u00a0Eur. testing for histamine and depressor substances using guinea-pigs and cats: the end of an era<\/a>\u201d, published in <em>Pharmeuropa Bio &amp; Scientific Notes<\/em> in March 2024.<\/p><p><img decoding=\"async\" class=\" wp-image-5833 alignleft\" src=\"https:\/\/annualreport.edqm.eu\/wp-content\/uploads\/2026\/06\/EDQM_On_Air_icon_rounded_2048px-300x300.png\" alt=\"\" width=\"55\" height=\"55\" srcset=\"https:\/\/annualreport.edqm.eu\/wp-content\/uploads\/2026\/06\/EDQM_On_Air_icon_rounded_2048px-300x300.png 300w, https:\/\/annualreport.edqm.eu\/wp-content\/uploads\/2026\/06\/EDQM_On_Air_icon_rounded_2048px-1024x1024.png 1024w, https:\/\/annualreport.edqm.eu\/wp-content\/uploads\/2026\/06\/EDQM_On_Air_icon_rounded_2048px-150x150.png 150w, https:\/\/annualreport.edqm.eu\/wp-content\/uploads\/2026\/06\/EDQM_On_Air_icon_rounded_2048px-768x768.png 768w, https:\/\/annualreport.edqm.eu\/wp-content\/uploads\/2026\/06\/EDQM_On_Air_icon_rounded_2048px-1536x1536.png 1536w, https:\/\/annualreport.edqm.eu\/wp-content\/uploads\/2026\/06\/EDQM_On_Air_icon_rounded_2048px-12x12.png 12w, https:\/\/annualreport.edqm.eu\/wp-content\/uploads\/2026\/06\/EDQM_On_Air_icon_rounded_2048px-600x600.png 600w, https:\/\/annualreport.edqm.eu\/wp-content\/uploads\/2026\/06\/EDQM_On_Air_icon_rounded_2048px.png 2048w\" sizes=\"(max-width: 55px) 100vw, 55px\" \/><\/p><p><strong><a href=\"https:\/\/annualreport.edqm.eu\/facts-and-figures\/#on-air-animals\" rel=\"noopener\"><em>EDQM On Air<\/em> \u2013 A win for animals \u2013 Phasing out the rabbit pyrogen test<\/a><\/strong><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-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\">A major step towards animal-free testing for the test for bacterial endotoxins<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-781c279 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\/03\/pyrogenicity-news.jpg\" class=\"attachment-full size-full wp-image-5157\" alt=\"\" srcset=\"https:\/\/annualreport.edqm.eu\/wp-content\/uploads\/2026\/03\/pyrogenicity-news.jpg 870w, https:\/\/annualreport.edqm.eu\/wp-content\/uploads\/2026\/03\/pyrogenicity-news-300x169.jpg 300w, https:\/\/annualreport.edqm.eu\/wp-content\/uploads\/2026\/03\/pyrogenicity-news-768x432.jpg 768w, https:\/\/annualreport.edqm.eu\/wp-content\/uploads\/2026\/03\/pyrogenicity-news-18x10.jpg 18w, https:\/\/annualreport.edqm.eu\/wp-content\/uploads\/2026\/03\/pyrogenicity-news-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 class=\"Summary\"><em><strong>The Ph. Eur. has added a new animal\u2011free recombinant factor C testing method for bacterial endotoxins, offering a sustainable alternative to horseshoe crab\u2011derived reagents and enabling a shift to reliable, non\u2011animal methods from 2026 onwards.<\/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 inclusion of the recombinant factor C (rFC) method in the Ph.\u00a0Eur. and suppression of the general chapter<em> Pyrogens (2.6.8)<\/em> represent significant advances in animal\u2011free pyrogen testing and reflect the EDQM\u2019s clear commitment to protecting animal welfare while ensuring the highest standards of patient safety and scientific rigour.<\/p><p>Effective 1\u00a0January 2026, the rabbit pyrogen test no longer appears in Ph.\u00a0Eur. texts, with pyrogen testing instead relying on modern, animal-free, science-driven approaches.<\/p><p>The rFC method, included in Ph. Eur. Issue 13.1 as one of the approved techniques for bacterial endotoxin testing, provides an animal\u2011free alternative that reduces reliance on natural resources such as the horseshoe crab. Users retain a choice of methods, guided by risk assessment and suitability under new general chapter <em>5.1.13 Pyrogenicity<\/em>. The EPC is also monitoring progress on emerging recombinant cascade reagents, which may be considered in future revisions as an alternative method.<\/p><p><img decoding=\"async\" class=\" wp-image-5833 alignleft\" src=\"https:\/\/annualreport.edqm.eu\/wp-content\/uploads\/2026\/06\/EDQM_On_Air_icon_rounded_2048px-300x300.png\" alt=\"\" width=\"55\" height=\"55\" srcset=\"https:\/\/annualreport.edqm.eu\/wp-content\/uploads\/2026\/06\/EDQM_On_Air_icon_rounded_2048px-300x300.png 300w, https:\/\/annualreport.edqm.eu\/wp-content\/uploads\/2026\/06\/EDQM_On_Air_icon_rounded_2048px-1024x1024.png 1024w, https:\/\/annualreport.edqm.eu\/wp-content\/uploads\/2026\/06\/EDQM_On_Air_icon_rounded_2048px-150x150.png 150w, https:\/\/annualreport.edqm.eu\/wp-content\/uploads\/2026\/06\/EDQM_On_Air_icon_rounded_2048px-768x768.png 768w, https:\/\/annualreport.edqm.eu\/wp-content\/uploads\/2026\/06\/EDQM_On_Air_icon_rounded_2048px-1536x1536.png 1536w, https:\/\/annualreport.edqm.eu\/wp-content\/uploads\/2026\/06\/EDQM_On_Air_icon_rounded_2048px-12x12.png 12w, https:\/\/annualreport.edqm.eu\/wp-content\/uploads\/2026\/06\/EDQM_On_Air_icon_rounded_2048px-600x600.png 600w, https:\/\/annualreport.edqm.eu\/wp-content\/uploads\/2026\/06\/EDQM_On_Air_icon_rounded_2048px.png 2048w\" sizes=\"(max-width: 55px) 100vw, 55px\" \/><\/p><p><span style=\"color: #ffffff;\"><strong><a style=\"color: #ffffff;\" href=\"https:\/\/annualreport.edqm.eu\/facts-and-figures\/#on-air-animals\" rel=\"noopener\"><em>EDQM On Air<\/em> \u2013 A win for animals \u2013 Phasing out the rabbit pyrogen test<\/a><\/strong><\/span><\/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\">Publication of three new Ph. Eur. general chapters on plastic materials for containers<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-74ba906 elementor-widget elementor-widget-image\" data-id=\"74ba906\" 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\/Virgin-raw-material-Polycarbonate-resin-Natural-polycarbonate-polymer-blue-background.jpg\" class=\"attachment-full size-full wp-image-5348\" alt=\"\" srcset=\"https:\/\/annualreport.edqm.eu\/wp-content\/uploads\/2026\/05\/Virgin-raw-material-Polycarbonate-resin-Natural-polycarbonate-polymer-blue-background.jpg 870w, https:\/\/annualreport.edqm.eu\/wp-content\/uploads\/2026\/05\/Virgin-raw-material-Polycarbonate-resin-Natural-polycarbonate-polymer-blue-background-300x169.jpg 300w, https:\/\/annualreport.edqm.eu\/wp-content\/uploads\/2026\/05\/Virgin-raw-material-Polycarbonate-resin-Natural-polycarbonate-polymer-blue-background-768x432.jpg 768w, https:\/\/annualreport.edqm.eu\/wp-content\/uploads\/2026\/05\/Virgin-raw-material-Polycarbonate-resin-Natural-polycarbonate-polymer-blue-background-18x10.jpg 18w, https:\/\/annualreport.edqm.eu\/wp-content\/uploads\/2026\/05\/Virgin-raw-material-Polycarbonate-resin-Natural-polycarbonate-polymer-blue-background-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 class=\"Summary\"><em><strong>Three new general chapters on plastic materials used in pharmaceutical containers were published to provide clearer, more detailed quality requirements and enable safer and more consistent packaging practices.<\/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>Adopted at the EPC\u2019s 180th session, these chapters expand the Ph.\u00a0Eur.\u2019s coverage of plastic materials used for pharmaceutical containers. <em>Cyclo\u2011olefin polymers (3.1.16)<\/em>, <em>Cyclo\u2011olefin copolymers (3.1.17)<\/em> and <em>Styrene block copolymers for containers and closures for parenteral preparations and ophthalmic preparations (3.1.18)<\/em> will help standardise analytical procedures and specifications for these widely employed substances.<\/p><p>These are the first new texts in section <em>3.1.\u00a0Materials used for the manufacture of containers <\/em>since 2001 and the first in this section to reference the general chapter on <em>Extractable elements in plastic materials for pharmaceutical use (2.4.35)<\/em>. They were published in Issue\u00a012.1 of the Ph.\u00a0Eur. in July\u00a02025, with implementation on 1\u00a0January 2026.<\/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-df5f41f wl-expand-toggle elementor-widget elementor-widget-button\" data-id=\"df5f41f\" 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\">Modernising excipient monographs: revised identification techniques and new CRSs<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-d60e2a0 elementor-widget elementor-widget-image\" data-id=\"d60e2a0\" 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\/vials-870.jpg\" class=\"attachment-full size-full wp-image-5349\" alt=\"\" srcset=\"https:\/\/annualreport.edqm.eu\/wp-content\/uploads\/2026\/05\/vials-870.jpg 870w, https:\/\/annualreport.edqm.eu\/wp-content\/uploads\/2026\/05\/vials-870-300x169.jpg 300w, https:\/\/annualreport.edqm.eu\/wp-content\/uploads\/2026\/05\/vials-870-768x432.jpg 768w, https:\/\/annualreport.edqm.eu\/wp-content\/uploads\/2026\/05\/vials-870-18x10.jpg 18w, https:\/\/annualreport.edqm.eu\/wp-content\/uploads\/2026\/05\/vials-870-800x450.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 class=\"Summary\"><em><strong>The Ph.\u00a0Eur. revised several excipient monographs and added new reference standards to support advanced testing.<\/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>Several revised excipient monographs and new reference standards were added to the Ph.\u00a0Eur. in 2024\/2025 to promote modern infrared (IR) identification techniques and replace reference spectra with chemical reference substances. These revisions were published in Ph.\u00a0Eur. Supplement\u00a011.6 and implemented on 1\u00a0January 2025.<\/p><p>Updates included IR identification methods for various polysorbates, all of which now describe an IR identification by chemical reference substances (CRSs), and propylene glycol, which describes a new IR identification using\u00a0<em>Propylene glycol for identification CRS<\/em>\u00a0instead of the previous mix of chemical and physical tests. Additional monographs, such as <em>Carnauba wax (0597)<\/em>, <em>Beeswax, white (0069)<\/em>\u00a0and\u00a0<em>Beeswax, yellow (0070)<\/em>, were also modernised.<\/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\">EPC adopts groundbreaking chapter on cell-based preparations for human use<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-98fe87b elementor-widget elementor-widget-image\" data-id=\"98fe87b\" 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-image-Public-consultation-on-a-new-general-chapter-on-cell-based-preparations-for-human-use-in-Pharmeuropa-36.2-20240429.jpg\" class=\"attachment-full size-full wp-image-5350\" alt=\"\" srcset=\"https:\/\/annualreport.edqm.eu\/wp-content\/uploads\/2026\/05\/News-image-Public-consultation-on-a-new-general-chapter-on-cell-based-preparations-for-human-use-in-Pharmeuropa-36.2-20240429.jpg 870w, https:\/\/annualreport.edqm.eu\/wp-content\/uploads\/2026\/05\/News-image-Public-consultation-on-a-new-general-chapter-on-cell-based-preparations-for-human-use-in-Pharmeuropa-36.2-20240429-300x169.jpg 300w, https:\/\/annualreport.edqm.eu\/wp-content\/uploads\/2026\/05\/News-image-Public-consultation-on-a-new-general-chapter-on-cell-based-preparations-for-human-use-in-Pharmeuropa-36.2-20240429-768x432.jpg 768w, https:\/\/annualreport.edqm.eu\/wp-content\/uploads\/2026\/05\/News-image-Public-consultation-on-a-new-general-chapter-on-cell-based-preparations-for-human-use-in-Pharmeuropa-36.2-20240429-18x10.jpg 18w, https:\/\/annualreport.edqm.eu\/wp-content\/uploads\/2026\/05\/News-image-Public-consultation-on-a-new-general-chapter-on-cell-based-preparations-for-human-use-in-Pharmeuropa-36.2-20240429-800x450.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-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 class=\"Summary\"><em><strong>A new chapter established standards for cell\u2011based medicinal products, addressing safety, quality and consistency in this fast\u2011growing field.<\/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>The EPC adopted a new general chapter, <em>Cell\u2011based preparations for human use (5.32)<\/em>, at its 181st session in March 2025, crowning several years of work by the Cell Therapy Products Working Party. The text was published in Issue 12.2 of the Ph.\u00a0Eur. in October 2025 and entered into force on 1 April 2026.<\/p><p>The chapter provides a comprehensive but flexible framework for the production and quality control of cell\u2011based preparations, complemented by four detailed sections outlining specific requirements for human haematopoietic stem cells, human chondrocytes, human limbal stem cells and human mesenchymal stromal cells. Its adoption follows earlier work on <a href=\"https:\/\/www.edqm.eu\/en\/-\/new-european-pharmacopoeia-commission-approach-to-gene-therapy-1?p_l_back_url=%2Fen%2Fsearch%3Fq%3DGTP%2Badopted%2B5.34%2B3186\" target=\"_blank\" rel=\"noopener\">gene therapy medicinal products<\/a> and formed part of the EPC\u2019s priorities for 2023-2025.<\/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-2137a81 elementor-section-stretched animated-slow elementor-section-boxed elementor-section-height-default elementor-section-height-default elementor-invisible\" data-id=\"2137a81\" 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-64f1686 wl-expand-block\" data-id=\"64f1686\" 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-348abc0 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"348abc0\" data-element_type=\"section\" data-e-type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-inner-column elementor-element elementor-element-820e542 wl-expand-block\" data-id=\"820e542\" 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-278d704 elementor-widget elementor-widget-heading\" data-id=\"278d704\" 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\">First three general texts on mRNA vaccines published<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-1b76d11 elementor-widget elementor-widget-image\" data-id=\"1b76d11\" 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-mRNA.jpg\" class=\"attachment-full size-full wp-image-5335\" alt=\"\" srcset=\"https:\/\/annualreport.edqm.eu\/wp-content\/uploads\/2026\/05\/news-mRNA.jpg 870w, https:\/\/annualreport.edqm.eu\/wp-content\/uploads\/2026\/05\/news-mRNA-300x169.jpg 300w, https:\/\/annualreport.edqm.eu\/wp-content\/uploads\/2026\/05\/news-mRNA-768x432.jpg 768w, https:\/\/annualreport.edqm.eu\/wp-content\/uploads\/2026\/05\/news-mRNA-18x10.jpg 18w, https:\/\/annualreport.edqm.eu\/wp-content\/uploads\/2026\/05\/news-mRNA-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-b0520a7 elementor-widget elementor-widget-text-editor\" data-id=\"b0520a7\" 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 class=\"Summary\"><em><strong>Three foundational texts addressing mRNA vaccines set the first harmonised quality standards for this emerging platform, supporting innovation in vaccine development.<\/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-54cc977 wl-expand-content elementor-widget elementor-widget-text-editor\" data-id=\"54cc977\" 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 EPC adopted three foundational general texts on messenger ribonucleic acid (mRNA) vaccines and their components at its 180th session in November 2024. Covering mRNA\u2011lipid nanoparticle (LNP) medicinal products, mRNA active substances and linear deoxyribonucleic acid (DNA) templates, these texts support innovation by establishing harmonised quality requirements for this rapidly evolving field.<\/p><p>The texts were drafted through the collaborative work of the mRNAVAC Working Party, bringing together experts from industry, academia, regulatory agencies and national control laboratories. They incorporate practical experience gained during and after the COVID\u201119 pandemic and provide a production and control framework for developers and regulators. The texts were published in Ph. Eur. Issue 12.1 (July 2025).<\/p><p><img decoding=\"async\" class=\" wp-image-5833 alignleft\" src=\"https:\/\/annualreport.edqm.eu\/wp-content\/uploads\/2026\/06\/EDQM_On_Air_icon_rounded_2048px-300x300.png\" alt=\"\" width=\"55\" height=\"55\" srcset=\"https:\/\/annualreport.edqm.eu\/wp-content\/uploads\/2026\/06\/EDQM_On_Air_icon_rounded_2048px-300x300.png 300w, https:\/\/annualreport.edqm.eu\/wp-content\/uploads\/2026\/06\/EDQM_On_Air_icon_rounded_2048px-1024x1024.png 1024w, https:\/\/annualreport.edqm.eu\/wp-content\/uploads\/2026\/06\/EDQM_On_Air_icon_rounded_2048px-150x150.png 150w, https:\/\/annualreport.edqm.eu\/wp-content\/uploads\/2026\/06\/EDQM_On_Air_icon_rounded_2048px-768x768.png 768w, https:\/\/annualreport.edqm.eu\/wp-content\/uploads\/2026\/06\/EDQM_On_Air_icon_rounded_2048px-1536x1536.png 1536w, https:\/\/annualreport.edqm.eu\/wp-content\/uploads\/2026\/06\/EDQM_On_Air_icon_rounded_2048px-12x12.png 12w, https:\/\/annualreport.edqm.eu\/wp-content\/uploads\/2026\/06\/EDQM_On_Air_icon_rounded_2048px-600x600.png 600w, https:\/\/annualreport.edqm.eu\/wp-content\/uploads\/2026\/06\/EDQM_On_Air_icon_rounded_2048px.png 2048w\" sizes=\"(max-width: 55px) 100vw, 55px\" \/><\/p><p><strong><span style=\"color: #163a87;\"><a style=\"color: #163a87;\" href=\"https:\/\/annualreport.edqm.eu\/facts-and-figures\/#on-air-biologicals\" rel=\"noopener\"><em>EDQM On Air<\/em> \u2013 The evolution of biologicals in the European Pharmacopoeia<\/a><\/span><\/strong><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-7274fc9 wl-expand-toggle elementor-widget elementor-widget-button\" data-id=\"7274fc9\" 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-7fcd176 elementor-section-stretched animated-slow elementor-section-boxed elementor-section-height-default elementor-section-height-default elementor-invisible\" data-id=\"7fcd176\" 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-21dfda9 wl-expand-block\" data-id=\"21dfda9\" 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-8533dca elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"8533dca\" 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-cec57ec wl-expand-block\" data-id=\"cec57ec\" 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-78a5ba5 elementor-widget elementor-widget-heading\" data-id=\"78a5ba5\" 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\">EPC adopts cutting-edge HTS chapter to enhance viral contaminant detection in biological products<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-3938c6d elementor-widget elementor-widget-image\" data-id=\"3938c6d\" 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\/Sequencing_870.jpg\" class=\"attachment-full size-full wp-image-5357\" alt=\"\" srcset=\"https:\/\/annualreport.edqm.eu\/wp-content\/uploads\/2026\/05\/Sequencing_870.jpg 870w, https:\/\/annualreport.edqm.eu\/wp-content\/uploads\/2026\/05\/Sequencing_870-300x169.jpg 300w, https:\/\/annualreport.edqm.eu\/wp-content\/uploads\/2026\/05\/Sequencing_870-768x432.jpg 768w, https:\/\/annualreport.edqm.eu\/wp-content\/uploads\/2026\/05\/Sequencing_870-18x10.jpg 18w, https:\/\/annualreport.edqm.eu\/wp-content\/uploads\/2026\/05\/Sequencing_870-800x450.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-ab31d21 elementor-widget elementor-widget-text-editor\" data-id=\"ab31d21\" 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 class=\"Summary\"><em><strong>The EPC adopted a new high\u2011throughput sequencing (HTS) chapter to improve the detection of viral contaminants in biological products, thereby supporting patient safety, modernising the Ph. Eur. and replacing\u00a0animal-based tests wherever possible.<\/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-dd6528d wl-expand-content elementor-widget elementor-widget-text-editor\" data-id=\"dd6528d\" 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 EPC adopted a new general chapter, <em>High\u2011throughput sequencing for the detection of viral extraneous agents<\/em> (<em>2.6.41.)<\/em>, at its 181st session in March 2025. The text was published in Issue\u00a012.2 of the Ph.\u00a0Eur. in October\u00a02025 and entered into force on 1\u00a0April 2026.<\/p><p>Known as next-generation sequencing, HTS is a state-of-the-art molecular biology technology that offers a broad approach to detecting known and unknown viral contaminants in biological products, including vaccines, recombinant proteins, viral vectors used for gene therapy and cell-based preparations for cell therapy. The technology enables better detection of viral extraneous agents and may contribute to improving animal welfare by replacing certain <em>in vivo<\/em> tests.<\/p><p>This chapter is intended to support users in implementing the new technology. It outlines the HTS workflow, the design of the method (non-targeted and targeted HTS), analytical approaches (genomics, viromics and transcriptomics) and the controls used in the routine test. It also provides guidelines for HTS method validation, including recommendations for selecting spiking materials and the evaluation of the relevant performance characteristics for HTS, as well as product-specific validation.<\/p><p>As a top priority for 2023-2025, the adoption of this general chapter demonstrates the EPC\u2019s unwavering commitment to further modernising the Ph.\u00a0Eur. and replacing <em>in vivo<\/em> tests wherever possible.<\/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-321baa0 wl-expand-toggle elementor-widget elementor-widget-button\" data-id=\"321baa0\" 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-3ac66e7 wl-expand-block\" data-id=\"3ac66e7\" 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-41daf4b elementor-widget elementor-widget-heading\" data-id=\"41daf4b\" 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\">EPC adopts mycoplasmas general chapter and monographs, updated to incorporate latest analytical developments<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-c94c8b8 elementor-widget elementor-widget-image\" data-id=\"c94c8b8\" 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<figure class=\"wp-caption\">\n\t\t\t\t\t\t\t\t\t\t<img loading=\"lazy\" decoding=\"async\" width=\"869\" height=\"489\" src=\"https:\/\/annualreport.edqm.eu\/wp-content\/uploads\/2026\/05\/M.-pneumoniae-FH-870x489-Green-Colour-Version.jpg\" class=\"attachment-full size-full wp-image-5358\" alt=\"\" srcset=\"https:\/\/annualreport.edqm.eu\/wp-content\/uploads\/2026\/05\/M.-pneumoniae-FH-870x489-Green-Colour-Version.jpg 869w, https:\/\/annualreport.edqm.eu\/wp-content\/uploads\/2026\/05\/M.-pneumoniae-FH-870x489-Green-Colour-Version-300x169.jpg 300w, https:\/\/annualreport.edqm.eu\/wp-content\/uploads\/2026\/05\/M.-pneumoniae-FH-870x489-Green-Colour-Version-768x432.jpg 768w, https:\/\/annualreport.edqm.eu\/wp-content\/uploads\/2026\/05\/M.-pneumoniae-FH-870x489-Green-Colour-Version-18x10.jpg 18w, https:\/\/annualreport.edqm.eu\/wp-content\/uploads\/2026\/05\/M.-pneumoniae-FH-870x489-Green-Colour-Version-800x450.jpg 800w\" sizes=\"(max-width: 869px) 100vw, 869px\" \/>\t\t\t\t\t\t\t\t\t\t\t<figcaption class=\"widget-image-caption wp-caption-text\">\u00a9 R. Rosengarten<\/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-9b0e5eb elementor-widget elementor-widget-text-editor\" data-id=\"9b0e5eb\" 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 class=\"Summary\"><em><strong>Updated standards incorporating the latest analytical technologies ensure more sensitive and reliable detection of mycoplasmas.<\/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-a13569e wl-expand-content elementor-widget elementor-widget-text-editor\" data-id=\"a13569e\" 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>During its 181st session in March 2025, the EPC adopted the general chapter on <em>Mycoplasmas<\/em> (<em>2.6.7)\u00a0<\/em>and 11 related monographs, all of which had been revised to reflect a new, less prescriptive, risk-based testing strategy. The texts were published in Ph.\u00a0Eur. Issue\u00a012.2 in October 2025 and entered into force on 1\u00a0April 2026.<\/p><p>The revised general chapter specifies that both the culture method and the indicator cell culture method (or, alternatively, a nucleic amplification technique) should be used conjointly to ensure the detection of both \u201ccultivable\u201d and \u201cnon-cultivable\u201d mycoplasmas, unless a monograph states otherwise or unless justified by a risk assessment and authorised by the competent authority. It also clarifies that samples should contain both cells and supernatant whenever possible. Furthermore, users may select suitable strains from the proposed list, with the possibility of including additional strains based on a risk assessment that considers product type and manufacturing process.<\/p><p>As a result of the changes made to general chapter <em>2.6.7<\/em>, 11 monographs were revised to remove specific instructions on the method to be applied or the volume to be used for testing. Two individual monographs on vaccines for human use (<em>Smallpox vaccine (live) (0164) <\/em>and<em> Yellow fever vaccine (0537)<\/em>) now indicate that the test is carried out on the single harvest. With the agreement of the competent authority, the test may alternatively be carried out on the pooled harvests.<\/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-17369e2 wl-expand-toggle elementor-widget elementor-widget-button\" data-id=\"17369e2\" 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-d1f5e0a elementor-section-stretched animated-slow elementor-section-boxed elementor-section-height-default elementor-section-height-default elementor-invisible\" data-id=\"d1f5e0a\" 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-c594721 wl-expand-block\" data-id=\"c594721\" 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-8ab73d1 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"8ab73d1\" 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-83496de wl-expand-block\" data-id=\"83496de\" 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-9c57d6c elementor-widget elementor-widget-heading\" data-id=\"9c57d6c\" 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 Pharmacopoeia publishes first individual monoclonal antibody medicinal product monograph<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-000d65d elementor-widget elementor-widget-image\" data-id=\"000d65d\" 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\/Golimumab-injection-news.jpg\" class=\"attachment-full size-full wp-image-5359\" alt=\"\" srcset=\"https:\/\/annualreport.edqm.eu\/wp-content\/uploads\/2026\/05\/Golimumab-injection-news.jpg 870w, https:\/\/annualreport.edqm.eu\/wp-content\/uploads\/2026\/05\/Golimumab-injection-news-300x169.jpg 300w, https:\/\/annualreport.edqm.eu\/wp-content\/uploads\/2026\/05\/Golimumab-injection-news-768x432.jpg 768w, https:\/\/annualreport.edqm.eu\/wp-content\/uploads\/2026\/05\/Golimumab-injection-news-18x10.jpg 18w, https:\/\/annualreport.edqm.eu\/wp-content\/uploads\/2026\/05\/Golimumab-injection-news-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-39ef385 elementor-widget elementor-widget-text-editor\" data-id=\"39ef385\" 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 Ph.\u00a0Eur.\u2019s first monograph for an individual monoclonal antibody (Golimumab injection) was published, offering a precedent\u2011setting, detailed specification for a complex biological medicine.<\/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-d3632ad wl-expand-content elementor-widget elementor-widget-text-editor\" data-id=\"d3632ad\" 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 Ph.\u00a0Eur. published its first monograph for a monoclonal antibody (mAb) medicinal product, <em>Golimumab injection (3187)<\/em>, an IgG1-antibody based TNF-alpha antagonist. The new monograph was published in Ph.\u00a0Eur. Issue\u00a012.2 in October 2025 and entered into force on 1\u00a0April 2026.<\/p><p>This monograph joined <em>Infliximab concentrated solution (2928)<\/em>, as well as the general chapters on <em>Cell-based assays for potency determination of TNF-alpha antagonists (2.7.26)<\/em> and <em>Capillary isoelectric focusing for recombinant therapeutic monoclonal antibodies (2.5.44)<\/em>, all three of which were elaborated as part of the <span style=\"text-decoration: underline;\"><a href=\"https:\/\/www.edqm.eu\/en\/-\/epc-successfully-concludes-pilot-phase-on-monoclonal-antibodies-setting-the-stage-for-future-standardisation-in-this-field?p_l_back_url=%2Fen%2Fsearch%3Fq%3Dmonoclonal\" target=\"_blank\" rel=\"noopener\"><span style=\"color: #ffffff; text-decoration: underline;\">mAb pilot phase<\/span><\/a><\/span>. An additional monograph, <em>Golimumab concentrated solution (3103)<\/em>, for another anti-TNF-alpha mAb was developed in parallel but using a single-source approach. Individual monographs on a TNF-alpha antagonist (adalimumab) and on a mAb that targets a different type of cytokines, i.e. interleukins (ustekinumab), as well as a general chapter on <em>Size-exclusion chromatography for recombinant therapeutic monoclonal antibodies (2.5.43)<\/em>, are also in the pipeline.<\/p><p>As the first individual medicinal product monograph covering a monoclonal antibody, <em>Golimumab injection (3187)<\/em> constitutes another milestone in the EPC\u2019s commitment to developing public standards for this class of biotherapeutics.<\/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-7d1c7bc wl-expand-toggle elementor-widget elementor-widget-button\" data-id=\"7d1c7bc\" 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-2e73f4e wl-expand-block\" data-id=\"2e73f4e\" 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-8e886b3 elementor-widget elementor-widget-heading\" data-id=\"8e886b3\" 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\">Ph. Eur. publication schedule evolves to better meet users\u2019 needs<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-1db3c47 elementor-widget elementor-widget-image\" data-id=\"1db3c47\" 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\/Publication-schedule_visual.jpg\" class=\"attachment-full size-full wp-image-5360\" alt=\"\" srcset=\"https:\/\/annualreport.edqm.eu\/wp-content\/uploads\/2026\/05\/Publication-schedule_visual.jpg 870w, https:\/\/annualreport.edqm.eu\/wp-content\/uploads\/2026\/05\/Publication-schedule_visual-300x169.jpg 300w, https:\/\/annualreport.edqm.eu\/wp-content\/uploads\/2026\/05\/Publication-schedule_visual-768x432.jpg 768w, https:\/\/annualreport.edqm.eu\/wp-content\/uploads\/2026\/05\/Publication-schedule_visual-18x10.jpg 18w, https:\/\/annualreport.edqm.eu\/wp-content\/uploads\/2026\/05\/Publication-schedule_visual-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-3e31a29 elementor-widget elementor-widget-text-editor\" data-id=\"3e31a29\" 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 class=\"Summary\"><em><strong>The Ph.\u00a0Eur. publication model is now better suited to users\u2019 professional requirements, ensuring access to standards as soon as they are ready.<\/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-07f54c2 wl-expand-content elementor-widget elementor-widget-text-editor\" data-id=\"07f54c2\" 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>As part of its transition to an online-only Ph.\u00a0Eur. from the 12th Edition (July 2025), the EDQM announced a major revision of the <span style=\"text-decoration: underline;\"><a href=\"https:\/\/go.edqm.eu\/PhEurschedule\" target=\"_blank\" rel=\"noopener\"><span style=\"color: #ffffff; text-decoration: underline;\">Ph.\u00a0Eur. publication schedule<\/span><\/a><\/span>. Under the new model \u2013 starting with Issue 13.1. \u2013 the six-month period between publication and implementation dates has been extended to nine months. This move was made to give users more time to prepare for future modifications and implementation of standards.<\/p><p>Ph. Eur. Issue 13.1 was published in April 2026, with an implementation date of January 2027 for its new and revised texts. The publication schedule for current and upcoming issues of the Ph.\u00a0Eur. is available on the EDQM website and the <a href=\"https:\/\/pheur-online.edqm.eu\/home\/\" target=\"_blank\" rel=\"noopener\"><span style=\"text-decoration: underline;\"><span style=\"color: #ffffff; text-decoration: underline;\">new Ph.\u00a0Eur. platform<\/span><\/span>.<\/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-e43ce22 wl-expand-toggle elementor-widget elementor-widget-button\" data-id=\"e43ce22\" 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 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content<\/span>\n\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/a>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<\/div>\n\t\t","protected":false},"excerpt":{"rendered":"<p>Tackling public health challenges R\u00e9pondre aux enjeux de sant\u00e9 publique Responding to evolving public health challenges requires agility, scientific rigour and close engagement with stakeholders. Throughout 2025, the European Directorate for the Quality of Medicines &amp; HealthCare (EDQM) advanced work across its core domains to address emerging needs and support the safety, quality and accessibility [&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-5299","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>Tackling public health challenges - 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\/tackling-public-health-challenges\/\" \/>\n<meta property=\"og:locale\" content=\"en_GB\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Tackling public health challenges\" \/>\n<meta property=\"og:description\" content=\"Tackling public health challenges R\u00e9pondre aux enjeux de sant\u00e9 publique Responding to evolving public health challenges requires agility, scientific rigour and close engagement with stakeholders. 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