{"id":1055,"date":"2023-08-08T07:27:10","date_gmt":"2023-08-08T10:27:10","guid":{"rendered":"https:\/\/www.vitapharmaconsulting.com\/en\/?post_type=noticias&#038;p=1055"},"modified":"2023-08-08T07:27:10","modified_gmt":"2023-08-08T10:27:10","slug":"ema-ich-opens-public-consultation-for-international-harmonization-of-real-world-evidence-terminology","status":"publish","type":"noticias","link":"https:\/\/www.vitapharmaconsulting.com\/en\/news\/2023\/08\/08\/ema-ich-opens-public-consultation-for-international-harmonization-of-real-world-evidence-terminology\/","title":{"rendered":"EMA &#8211; ICH opens public consultation for international harmonization of real-world evidence terminology"},"content":{"rendered":"<p>The European Medicines Agency has published for public consultation an ICH Reflection Paper on \u201c<em>Proposed international harmonisation of real-world evidence terminology and convergence of general principles regarding planning and reporting of studies using real-world data, with a focus on effectiveness of medicines<\/em>\u201d, co-authored by EMA, US-FDA (Food and Drug Administration) and Health Canada (Canada).<\/p>\n<p>This Reflection Paper builds on the 2022 statement from the International Coalition of Medicines Regulatory Authorities (ICMRA), offering a strategic approach for future ICH guidelines on the assessment of real-world data (RWD) and real-world evidence (RWE). It constitutes the first step towards international harmonisation of the following focus areas:<\/p>\n<ul>\n<li>Convergence on terminology for RWD and RWE.<\/li>\n<li>Format for protocols and reports of study results based on RWD submitted to regulatory agencies throughout the lifecycle of medicines.<\/li>\n<li>Registration of study protocols and reports.<\/li>\n<li>The assessment of RWD and RWE for regulatory purposes.<\/li>\n<\/ul>\n<p>The benefit of such harmonization is applicable to all types of medicinal products at any stage of their lifecycle, i.e., from development\/pre-approval to post-marketing monitoring. ICH guidance can increase the efficiency of resources across a large number of stakeholders, by aligning expectations of medicines regulators, medicines developers\/pharmaceutical industry, patient advocacy groups, contract research organisations, academia, and other stakeholders using RWD to generate evidence on medicinal products.<\/p>\n<p>So, the proposal can support timely decisions on the development of innovative treatments, help to address unmet medical needs, and support the safe and effective use of medicines.<\/p>\n<p>EMA is coordinating the public consultation in Europe in parallel with a consultation run by ICH, to ensure European stakeholders have the opportunity to comment.<\/p>\n<p>Comments should be provided using the template through the link <a href=\"https:\/\/bit.ly\/43QLvCq\">https:\/\/bit.ly\/43QLvCq<\/a> to be sent to <a href=\"mailto:ich@ema.europa.eu\">ich@ema.europa.eu<\/a> by 30 September 2023.<\/p>\n<p><strong>Your opinion is crucial to help shape the future ICH guidelines that will address the complexity of use and impact of RWD\/RWE in medicines regulation.<\/strong><\/p>\n","protected":false},"author":3,"featured_media":1056,"template":"","meta":{"inline_featured_image":false,"_links_to":"","_links_to_target":""},"categorias":[24,25],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v20.5 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>EMA - ICH opens public consultation for international harmonization of real-world evidence terminology - Vita<\/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:\/\/www.vitapharmaconsulting.com\/en\/news\/2023\/08\/08\/ema-ich-opens-public-consultation-for-international-harmonization-of-real-world-evidence-terminology\/\" \/>\n<meta property=\"og:locale\" content=\"pt_BR\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"EMA - ICH opens public consultation for international harmonization of real-world evidence terminology - Vita\" \/>\n<meta property=\"og:description\" content=\"The European Medicines Agency has published for public consultation an ICH Reflection Paper on \u201cProposed international harmonisation of real-world evidence terminology and convergence of general principles regarding planning and reporting of studies using real-world data, with a focus on effectiveness of medicines\u201d, co-authored by EMA, US-FDA (Food and Drug Administration) and Health Canada (Canada). 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