{"id":852,"date":"2020-03-24T14:52:41","date_gmt":"2020-03-24T13:52:41","guid":{"rendered":"https:\/\/pharmavalue.it\/?p=852"},"modified":"2022-06-30T16:04:36","modified_gmt":"2022-06-30T14:04:36","slug":"clinical-trial-drugs-compassionate-use-activation-procedure","status":"publish","type":"post","link":"https:\/\/pharmavalue.it\/en\/clinical-trial-drugs-compassionate-use-activation-procedure\/","title":{"rendered":"Drugs in clinical trials: compassionate use activation procedure"},"content":{"rendered":"<div data-elementor-type=\"wp-post\" data-elementor-id=\"852\" class=\"elementor elementor-852\" data-elementor-post-type=\"post\">\n\t\t\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-36937e69 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"36937e69\" 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-top-column elementor-element elementor-element-6704f8a9\" data-id=\"6704f8a9\" 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-7dbcbd11 elementor-widget elementor-widget-text-editor\" data-id=\"7dbcbd11\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<p><span style=\"font-weight: 400;\">In this time of COVID-19 emergency, one often hears about 'Compassionate Use'.<\/span><\/p><p><span style=\"font-weight: 400;\">DM 7\/9\/2017 regulates the free supply by pharmaceutical companies of:<\/span><\/p><ul style=\"list-style-type: disc;\"><li><span style=\"font-weight: 400; letter-spacing: 0px;\">medicines not yet authorised, in clinical trials and produced in pharmaceutical factories;<\/span><\/li><li><span style=\"font-weight: 400; letter-spacing: 0px;\">medicines with a marketing authorisation for other than authorised indications;<\/span><\/li><li><span style=\"font-weight: 400; letter-spacing: 0px;\">medicines authorised but not yet available in the country.<br \/><br \/><\/span><\/li><\/ul><p><span style=\"font-weight: 400;\">If the company is willing, free provision may be made for the treatment of patients with serious diseases, rare diseases and tumours or life-threatening conditions for whom there are no viable therapeutic alternatives available or who cannot be included in a clinical trial<\/span><\/p><p><span style=\"font-weight: 400;\">The DM also defines:<\/span><\/p><ul style=\"list-style-type: disc;\"><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">the role and activities of AIFA<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">who and how can apply<br \/><br \/><\/span><\/span><\/li><\/ul><p><span style=\"font-weight: 400;\">For more information:<\/span><\/p><p><span style=\"font-weight: 400;\"><a href=\"https:\/\/www.gazzettaufficiale.it\/eli\/id\/2017\/11\/02\/17A07305\/SG\"><u>Ministerial Decree of 7 September 2017 - Regulation of the therapeutic use of medicinal products<\/u><\/a><\/span><\/p><p><span style=\"font-weight: 400;\"><a href=\"https:\/\/www.aifa.gov.it\/documents\/20142\/847411\/FAQ-DR_uso_terapeutico_med_sper_clin_30.10.2019.pdf\/53b744f9-30f4-ebc8-5c1f-8d651520a745\"><u>AIFA Question and Answer Document<\/u><\/a><\/span><\/p><p><span style=\"font-weight: 400;\">On the AIFA website, the <a href=\"https:\/\/www.aifa.gov.it\/farmaci-a-uso-compassionevole\"><u>detailed documentation<\/u> <\/a>and the<a href=\"https:\/\/www.aifa.gov.it\/farmaci-a-uso-compassionevole\"> <u>list of active Compassionate Use programmes<\/u><\/a><\/span><\/p>\t\t\t\t\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-12e81d1 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"12e81d1\" 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-top-column elementor-element elementor-element-c46d45b\" data-id=\"c46d45b\" 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-2d2f0ff elementor-widget elementor-widget-shortcode\" data-id=\"2d2f0ff\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"shortcode.default\">\n\t\t\t\t\t\t\t<div class=\"elementor-shortcode\"><div class=\"_df_book df-lite\" id=\"df_920\"  _slug=\"procedura-uso-compassionevole\" data-title=\"procedura-uso-compassionevole\" wpoptions=\"true\" thumbtype=\"\" ><\/div><script class=\"df-shortcode-script\" nowprocket type=\"application\/javascript\">window.option_df_920 = {\"outline\":[],\"backgroundColor\":\"#eeeeee\",\"duration\":\"0\",\"autoEnableOutline\":\"false\",\"autoEnableThumbnail\":\"false\",\"overwritePDFOutline\":\"false\",\"direction\":\"1\",\"pageSize\":\"0\",\"pageMode\":\"1\",\"soundEnable\":\"false\",\"source\":\"https:\\\/\\\/pharmavalue.it\\\/wp-content\\\/uploads\\\/2021\\\/03\\\/procedura-uso-compassionevole_blog.pdf\",\"wpOptions\":\"true\"}; if(window.DFLIP && window.DFLIP.parseBooks){window.DFLIP.parseBooks();}<\/script><\/div>\n\t\t\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>","protected":false},"excerpt":{"rendered":"<p>In questo periodo di emergenza COVID-19 si sente parlare spesso di \u201cUso Compassionevole&#8221; Il DM 7\/9\/2017 disciplina la fornitura gratuita da parte di aziende farmaceutiche di: medicinali non ancora autorizzati, in sperimentazione clinica e prodotti in stabilimenti farmaceutici; medicinali provvisti dell&#8217;autorizzazione all&#8217;immissione in commercio per indicazioni diverse da quelle autorizzate; medicinali autorizzati ma non ancora [&hellip;]<\/p>\n","protected":false},"author":314,"featured_media":853,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_seopress_robots_primary_cat":"9","_seopress_titles_title":"","_seopress_titles_desc":"","_seopress_robots_index":"","footnotes":""},"categories":[9],"tags":[49],"class_list":["post-852","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-appunti","tag-valore-dei-farmaci"],"_links":{"self":[{"href":"https:\/\/pharmavalue.it\/en\/wp-json\/wp\/v2\/posts\/852","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/pharmavalue.it\/en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/pharmavalue.it\/en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/pharmavalue.it\/en\/wp-json\/wp\/v2\/users\/314"}],"replies":[{"embeddable":true,"href":"https:\/\/pharmavalue.it\/en\/wp-json\/wp\/v2\/comments?post=852"}],"version-history":[{"count":0,"href":"https:\/\/pharmavalue.it\/en\/wp-json\/wp\/v2\/posts\/852\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/pharmavalue.it\/en\/wp-json\/wp\/v2\/media\/853"}],"wp:attachment":[{"href":"https:\/\/pharmavalue.it\/en\/wp-json\/wp\/v2\/media?parent=852"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/pharmavalue.it\/en\/wp-json\/wp\/v2\/categories?post=852"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/pharmavalue.it\/en\/wp-json\/wp\/v2\/tags?post=852"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}