{"id":7553,"date":"2015-01-27T11:28:54","date_gmt":"2015-01-27T10:28:54","guid":{"rendered":"http:\/\/www.fedaiisf.it\/?p=7553"},"modified":"2015-02-03T12:07:58","modified_gmt":"2015-02-03T11:07:58","slug":"ema-sospende-generici-approvati-india-caute-aifa-e-assogenerici","status":"publish","type":"post","link":"https:\/\/www.fedaiisf.it\/en\/ema-sospende-generici-approvati-india-caute-aifa-e-assogenerici\/","title":{"rendered":"EMA suspends generics approved in India. Caute Aifa and AssoGenerici"},"content":{"rendered":"

\"generici.indiani\"<\/a>The Committee for Medicinal Products for Human Use (CHMP) of theEuropean Medicines Agency (EMA) has recommended the suspension <\/a>the sale of about fifty generic drugs because their approvals were allegedly based on clinical trials conducted in an irregular manner by a contract research organization (CRO) based in Hyderabad (India).<\/p>\n

The drugs listed<\/a> (including candesartan, escitalopram, donepezil, esomeprazole, metformin) are marketed in several countries of the European Union (EU) in various doses. France, Germany, Belgium and Luxembourg have already suspended the sales of 25 drugs but the EMA, pending new data, leaves the decision on the possible adoption of suspensive measures to the individual national regulatory authorities.<\/p>\n

As a precautionary measure, the AIFA Technical-Scientific Commission has decided to initiate the suspension procedures for the drugs indicated by the EMA on the market in our country, while emphasizing \"\"that in Italy there is no risk of harmful effects or lack of efficacy of the medicinal products concerned, which however concern a marginal share of the market. "The measure suggested by the EMA Committee is dutifully based on the utmost caution but there are no elements to suggest the presence of dangers for patients" he confirms\u00a0Enrique H\u00e4usermann<\/b>, president of AssoGenerici.<\/p>\n

"In the case of Italy," he adds, "the products concerned concern 9 active ingredients for a total of about twenty medicines, some of which are not even currently on the market." The FDA has not yet taken any action in this regard. The inspection by the French Medicines Agency (Ansm) had detected in the Indian Cro - to which various European and non-European manufacturers of equivalent drugs had relied - "manipulation of electrocardiogram data in the performance of some studies of generic drugs" for at least 5 years, causing the EMA to question the integrity of the methodology of the studies and the reliability of the data generated. The accused company replies that the EMA's reaction is disproportionate: ECGs are not indispensable once bioequivalence has been demonstrated and the remarks made cannot be extended to the bioanalytical, pharmacokinetic and statistical aspects of the research.<\/p>\n

AZ \u2013 January 27, 2015 \u2013 Doctor33<\/a><\/p>\n

Related news: EMA recommends suspension of (generic) drugs tested in an Indian plant<\/a><\/p>\n

Related news: Aifa orders Visuglican medicinal withdrawal<\/a><\/p>\n

AIFA press release: EMA recommends suspending drugs tested in an Indian plant<\/a><\/p>","protected":false},"excerpt":{"rendered":"

Il comitato per i medicinali per uso umano (Chmp) dell’Agenzia europea per i medicinali (Ema) ha raccomandato la sospensione della vendita di circa una cinquantina di farmaci generici in quanto le loro approvazioni si sarebbero basate su sperimentazioni cliniche condotte con modalit\u00e0 irregolari da un’organizzazione di ricerca a contratto (Cro) con sede a Hyderabad (India). …<\/p>","protected":false},"author":4,"featured_media":7563,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[16],"tags":[49,31],"class_list":["post-7553","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-primo-piano","tag-aifa","tag-generici"],"amp_enabled":true,"_links":{"self":[{"href":"https:\/\/www.fedaiisf.it\/en\/wp-json\/wp\/v2\/posts\/7553","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=7553"}],"version-history":[{"count":0,"href":"https:\/\/www.fedaiisf.it\/en\/wp-json\/wp\/v2\/posts\/7553\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.fedaiisf.it\/en\/wp-json\/wp\/v2\/media\/7563"}],"wp:attachment":[{"href":"https:\/\/www.fedaiisf.it\/en\/wp-json\/wp\/v2\/media?parent=7553"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.fedaiisf.it\/en\/wp-json\/wp\/v2\/categories?post=7553"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.fedaiisf.it\/en\/wp-json\/wp\/v2\/tags?post=7553"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}