{"id":20868,"date":"2024-01-10T09:00:00","date_gmt":"2024-01-10T08:00:00","guid":{"rendered":"https:\/\/www.a-stw.com\/?p=20868"},"modified":"2024-01-09T11:43:10","modified_gmt":"2024-01-09T10:43:10","slug":"digital-medical-information-eu","status":"publish","type":"post","link":"https:\/\/www.a-stw.com\/en\/digital-medical-information-eu\/","title":{"rendered":"Digital Medical Information in the European Union"},"content":{"rendered":"\n<p>The world is rapidly advancing towards the <strong>digitization of documents and processes<\/strong>, progressively transforming how information is created, shared, and archived. In line with this shift, the <strong>European Union<\/strong> aims to explore a new platform to record and catalogue <strong>digital medical information for authorized pharmaceuticals<\/strong>.<\/p>\n\n\n\n<p>At the close of 2023, the <strong>Heads of Medicines Agencies (HMA)<\/strong>, the <strong>European Commission<\/strong>, and the E<strong>uropean Medicines Agency (EMA)<\/strong> jointly released electronic product information (ePI) for certain human medicines, marking the first-ever publication of such electronic information.<\/p>\n\n\n\n<p>When it comes to pharmaceuticals products, the information must encompass various <strong>product characteristics<\/strong>,<strong> labelling details<\/strong>, and <strong>package inserts<\/strong>. These documents are mandatory accompaniments for any authorized medicinal product within the European Union, offering precise information regarding their usage and prescription.<\/p>\n\n\n\n<p>Currently, they can be readily found online, within the websites of various regulatory authorities (in PDF format), as well as in print within the packaging of pharmaceuticals.<\/p>\n\n\n\n<p>\u201cDigital platforms open new possibilities to share this information electronically, <strong>keep it constantly updated<\/strong> and make it <strong>more accessible<\/strong> to end-users such as healthcare professionals and patients.\u201d With these words, the European Commission introduces this new initiative, a pilot program designed to test a novel model for publishing digital medical information on pharmaceuticals.<\/p>\n\n\n\n<p class=\"has-small-font-size\"><em>Related:<\/em><\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li class=\"has-small-font-size\"><a href=\"https:\/\/www.a-stw.com\/en\/introducing-the-european-medical-device-vigilance-system\/\" target=\"_blank\" rel=\"noreferrer noopener\"><em><mark style=\"background-color:rgba(0, 0, 0, 0)\" class=\"has-inline-color has-luminous-vivid-amber-color\">Introducing the European Medical Device Vigilance System<\/mark><\/em><\/a><\/li>\n\n\n\n<li class=\"has-small-font-size\"><a href=\"https:\/\/www.a-stw.com\/en\/who-2023-engaging-patients-for-patient-safety\/\" target=\"_blank\" rel=\"noreferrer noopener\"><em><mark style=\"background-color:rgba(0, 0, 0, 0)\" class=\"has-inline-color has-luminous-vivid-amber-color\">WHO 2023 &#8211; Engaging Patients for Patient Safety<\/mark><\/em><\/a><\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\">EU Platform and Digital Medical Information<\/h2>\n\n\n\n<p>As can be read on the EMA and European Commission websites: \u201cTransitioning to ePI offers advantages such as improved <strong>accessibility<\/strong>, <strong>searchability<\/strong> and <strong>multilingual capabilities\u201d<\/strong>. &nbsp;[\u2026] These ePIs were created following the EU ePI Common Standard, adopted by the European medicines regulatory network to provide a consistent structure throughout all Member States and ensure the information works across different e-health platforms\u201d.<\/p>\n\n\n\n<p>The initiative falls within the scope of the <strong>Pharmaceutical Strategy for Europe <\/strong>and involves 25 medicines.<\/p>\n\n\n\n<p>The initial ePI publications encompass medicines evaluated by EMA or by national authorities in Denmark, the Netherlands, Spain, and Sweden. These have been drafted <strong>in English<\/strong> for centrally approved medicines and in the <strong>local<\/strong> <strong>language<\/strong> for nationally approved drugs.<\/p>\n\n\n\n<p>Testing is currently underway to enable access in <strong>all languages of the Union<\/strong>.<\/p>\n\n\n\n<p>For those seeking further details, these documents can be viewed on the <a href=\"https:\/\/plm-portal.ema.europa.eu\/ePIAll\/\" target=\"_blank\" rel=\"noreferrer noopener\"><mark style=\"background-color:rgba(0, 0, 0, 0)\" class=\"has-inline-color has-luminous-vivid-amber-color\">Product Lifecycle Management Portal.<\/mark><\/a> More information can be found by consulting the dedicated pages on the websites of the <a href=\"https:\/\/ec.europa.eu\/newsroom\/sante\/items\/806520\/it\" target=\"_blank\" rel=\"noreferrer noopener\"><mark style=\"background-color:rgba(0, 0, 0, 0)\" class=\"has-inline-color has-luminous-vivid-amber-color\">European Commission<\/mark><\/a> and the <a href=\"https:\/\/www.ema.europa.eu\/en\/human-regulatory-overview\/marketing-authorisation\/product-information-requirements\/electronic-product-information-epi#pilot-project-to-test-epi-section\" target=\"_blank\" rel=\"noreferrer noopener\"><mark style=\"background-color:rgba(0, 0, 0, 0)\" class=\"has-inline-color has-luminous-vivid-amber-color\">EMA.<\/mark><\/a><\/p>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<p><sup>Image by Miguel \u00c1. Padri\u00f1\u00e1n from Pexels<\/sup><\/p>\n","protected":false},"excerpt":{"rendered":"<p>The world is rapidly advancing towards the digitization of documents and processes, progressively transforming how information is created, shared, and archived. In line with this shift, the European Union aims to explore a new platform to record and catalogue digital medical information for authorized pharmaceuticals. At the close of 2023, the Heads of Medicines Agencies [&hellip;]<\/p>\n","protected":false},"author":5,"featured_media":20869,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[241,251],"tags":[],"class_list":["post-20868","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-medical-translations","category-medical-writing-2"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v23.7 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>Digital Medical Information in the European Union - ASTW<\/title>\n<meta name=\"description\" content=\"the European Union aims to explore a new platform to record and catalogue digital medical information for authorized pharmaceuticals...\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.a-stw.com\/en\/digital-medical-information-eu\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Digital Medical Information in the European Union - 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