{"id":16106,"date":"2013-01-16T01:30:00","date_gmt":"2013-01-16T00:30:00","guid":{"rendered":"http:\/\/www.fedaiisf.it\/studi-clinici-sui-farmaci-allaifa-in-gu-il-provvedimento\/"},"modified":"2013-01-16T01:30:00","modified_gmt":"2013-01-16T00:30:00","slug":"studi-clinici-sui-farmaci-allaifa-in-gu-il-provvedimento","status":"publish","type":"post","link":"https:\/\/www.fedaiisf.it\/en\/studi-clinici-sui-farmaci-allaifa-in-gu-il-provvedimento\/","title":{"rendered":"Clinical trials on drugs at Aifa. In Gu the provision"},"content":{"rendered":"

It was published in the Official Gazette no. 10 of 12 January determines Aifa n. 1\/2013 with which the powers on clinical trials of medicines already attributed to the Higher Institute of Health are transferred to the Medicines Agency. In practice, phase I clinical trials and clinical trials with products for advanced therapies with the relevant substantial amendments are authorized by AIFA. However, as a note on the! site of the Higher Institute of Health, the new operating procedures for the request for admissibility to the Phase I clinical trial will be published with a Ministerial Decree, pursuant to art. 12, paragraph 9, of the decree-law n. 158\/2012. Therefore, at the moment there is a transitional phase in which AIFA makes use of the Istituto Superiore di Sanit\u00e0 for phase I trials, which continues to operate according to the previous procedures. Aifa liaises with the Institute for the purpose of issuing the relative authorisation, while the validation phase of the phase I trial applications remains the responsibility of the ISS. Phase I clinical trials and clinical trials with advanced therapy products with their substantial amendments are authorized by special provision! from Aifa.<\/span><\/p>\n

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January 16, 2013 \u2013 DoctorNews33<\/p>\n

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È stata pubblicata sulla Gazzetta Ufficiale n. 10 del 12 gennaio la determina Aifa n. 1\/2013 con la quale sono trasferite all’Agenzia del farmaco le competenze sulla sperimentazione clinica dei medicinali già attribuite all’Istituto superiore di sanità. In pratica le sperimentazioni cliniche di fase I e le sperimentazioni cliniche con prodotti per terapie avanzate con …<\/p>","protected":false},"author":1,"featured_media":9846,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[90],"tags":[],"class_list":["post-16106","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-fedaiisf-archivio-storico"],"amp_enabled":true,"_links":{"self":[{"href":"https:\/\/www.fedaiisf.it\/en\/wp-json\/wp\/v2\/posts\/16106","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.fedaiisf.it\/en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.fedaiisf.it\/en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.fedaiisf.it\/en\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/www.fedaiisf.it\/en\/wp-json\/wp\/v2\/comments?post=16106"}],"version-history":[{"count":0,"href":"https:\/\/www.fedaiisf.it\/en\/wp-json\/wp\/v2\/posts\/16106\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.fedaiisf.it\/en\/wp-json\/wp\/v2\/media\/9846"}],"wp:attachment":[{"href":"https:\/\/www.fedaiisf.it\/en\/wp-json\/wp\/v2\/media?parent=16106"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.fedaiisf.it\/en\/wp-json\/wp\/v2\/categories?post=16106"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.fedaiisf.it\/en\/wp-json\/wp\/v2\/tags?post=16106"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}