{"id":30087,"date":"2017-03-03T17:26:12","date_gmt":"2017-03-03T16:26:12","guid":{"rendered":"http:\/\/www.fedaiisf.it\/?p=30087"},"modified":"2017-03-03T17:26:12","modified_gmt":"2017-03-03T16:26:12","slug":"stati-uniti-ed-europa-decidono-porre-termine-alla-duplicazione-dei-controlli","status":"publish","type":"post","link":"https:\/\/www.fedaiisf.it\/en\/stati-uniti-ed-europa-decidono-porre-termine-alla-duplicazione-dei-controlli\/","title":{"rendered":"The United States and Europe decide to put an end to the duplication of controls"},"content":{"rendered":"

The regulatory agencies of the United States and the European Union<\/b> they agreed to recognize inspections of human drug manufacturing facilities in their territory<\/b> . Thus, both entities <\/span>they conclude with duplicity<\/span><\/b> of the revisions made to the production plants of pharmaceutical companies located in the\u00a0<\/span>United States, in the Union \"EE.UUEuropean and other parts of the world to ensure they operate in compliance with the\u00a0<\/span>Good Manufacturing Practices (GMP \u2013 <\/span><\/b>good manufacturing practices<\/span>)<\/span><\/b> established by both institutions. <\/span>Under the new agreement, each regulatory agency is responsible for carrying out inspections on its territory<\/b>, allowing its counterparty access to the relevant information, without the need for another check. So if an EU-based plant gets approval from the EMA<\/a>, it will also automatically get it from FDA<\/a>.<\/p>\n

The agreement will allow a <\/span>better use of inspection resources<\/span><\/b> to focus on <\/span>you check from\u00a0<\/span>carry out in other parts of the world, where the active substances and drugs are produced<\/span><\/b>\u00a0for markets in the EU and the US. <\/span>This will cause that patients can be confident in the quality, safety and efficacy of medicines<\/b>.<\/p>\n

St\"Risultatiia the EMA and the FDA have comparable regulatory and procedural frameworks for drug manufacturer inspections, which facilitates <\/span>the harmonization of inspections in installations.<\/span><\/b><\/p>\n

This agreement is an annex to the Mutual Recognition Agreement (MRA) of the EU and the US<\/b>, which was signed in 1998 but has not yet been implemented. Many provisions of the convention have already taken effect and others will do so soon<\/span>November 1, 2017. By then, the European Union will have completed its evaluation of the FDA and the US agency is expected to have completed its evaluation of at least eight EU member states, which will gradually roll out to\u00a0<\/span>rest.<\/span><\/p>\n

Since 2003 both agencies have intensified their cooperation<\/span><\/b> to promote better use of resources and proceed with the approval of new drugs.<\/span><\/p>\n

EL GOBAL \u2013\u00a0<\/b>Madrid \u2013 Viernes, 03 March 2017<\/span><\/a><\/p>\n

Related news:\u00a0European and US regulators agree on mutual recognition of inspections of medicines manufacturers<\/span><\/a><\/p>\n

<\/div>","protected":false},"excerpt":{"rendered":"

Le agenzie regolatorie degli Stati Uniti e dell’Unione europea hanno convenuto di riconoscere le ispezioni dei centri di produzione di farmaci per uso umano nel loro territorio . Cos\u00ec, entrambe le entit\u00e0 concludono con la doppiezza delle revisioni apportate agli impianti di produzione delle aziende farmaceutiche localizzate negli\u00a0Stati Uniti, nell’Unione Europea e in altre parti …<\/p>","protected":false},"author":4,"featured_media":29333,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[1],"tags":[49],"class_list":["post-30087","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-notizie","tag-aifa"],"amp_enabled":true,"_links":{"self":[{"href":"https:\/\/www.fedaiisf.it\/en\/wp-json\/wp\/v2\/posts\/30087","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\/4"}],"replies":[{"embeddable":true,"href":"https:\/\/www.fedaiisf.it\/en\/wp-json\/wp\/v2\/comments?post=30087"}],"version-history":[{"count":0,"href":"https:\/\/www.fedaiisf.it\/en\/wp-json\/wp\/v2\/posts\/30087\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.fedaiisf.it\/en\/wp-json\/wp\/v2\/media\/29333"}],"wp:attachment":[{"href":"https:\/\/www.fedaiisf.it\/en\/wp-json\/wp\/v2\/media?parent=30087"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.fedaiisf.it\/en\/wp-json\/wp\/v2\/categories?post=30087"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.fedaiisf.it\/en\/wp-json\/wp\/v2\/tags?post=30087"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}