{"id":17056,"date":"2013-09-14T01:30:00","date_gmt":"2013-09-13T23:30:00","guid":{"rendered":"http:\/\/www.fedaiisf.it\/casalesi-estorsione-ad-azienda-farmaceutica-anche-due-figli-del-boss-schiavone\/"},"modified":"2013-09-14T01:30:00","modified_gmt":"2013-09-13T23:30:00","slug":"casalesi-estorsione-ad-azienda-farmaceutica-anche-due-figli-del-boss-schiavone","status":"publish","type":"post","link":"https:\/\/www.fedaiisf.it\/en\/casalesi-estorsione-ad-azienda-farmaceutica-anche-due-figli-del-boss-schiavone\/","title":{"rendered":"Casalesi, extortion of two sons of boss Schiavone from a pharmaceutical company"},"content":{"rendered":"

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China's medicines regulatory body announced proposals to speed up the market review of generic medicines for which there is a high unmet clinical need, as well as innovative products and pediatric drug treatments. <\/p>\n

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China's State Food and Drug Administration has in fact closed a public consultation on some proposals to reform the drug registration process in the country. Its plans for generics reviews include a fast-track procedure for high-priority products, measures to discourage green light applications for medicines with little clinical value, and a boost to bioequivalence studies.<\/p>\n

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These moves follow a report from the Chinese body's Medicines Evaluation Center, which found that nearly 60% of the 3,950 quick go-ahead applications for new products it received in 2012 were for drugs for which more than 20 generic versions were already available. <\/p>\n

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An expedited approval process will also be available for new drugs with Chinese intellectual property and sponsored by the national government.<\/p>\n

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The Agency is also considering whether to allow data from clinical trials carried out abroad to be included in applications for authorisation.<\/p>\n

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BDC \u2013 January 24, 2013 \u2013 PharmaKronos<\/span><\/i><\/p>\n

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 L’ente regolatorio sui farmaci cinese ha annunciato proposte mirate ad accelerare l’esame per l’immissione in commercio di medicinali generici per i quali vi sia un alto bisogno clinico insoddisfatto, nonchè di prodotti innovativi e di trattamenti farmacologici pediatrici. La China-‘s State Food and Drug Administration ha infatti chiuso una consultazione pubblica su alcune proposte di …<\/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-17056","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\/17056","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=17056"}],"version-history":[{"count":0,"href":"https:\/\/www.fedaiisf.it\/en\/wp-json\/wp\/v2\/posts\/17056\/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=17056"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.fedaiisf.it\/en\/wp-json\/wp\/v2\/categories?post=17056"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.fedaiisf.it\/en\/wp-json\/wp\/v2\/tags?post=17056"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}