{"id":143092,"date":"2024-05-27T07:29:02","date_gmt":"2024-05-27T04:29:02","guid":{"rendered":"https:\/\/psnews.ro\/?p=143092"},"modified":"2024-05-27T11:02:47","modified_gmt":"2024-05-27T08:02:47","slug":"comisia-europeana-a-solicitat-statelor-membre-sa-suspende-autorizatia-pentru-o-serie-de-medicamente-generice-neconforme","status":"publish","type":"post","link":"https:\/\/psnews.ro\/comisia-europeana-a-solicitat-statelor-membre-sa-suspende-autorizatia-pentru-o-serie-de-medicamente-generice-neconforme\/","title":{"rendered":"Comisia European\u0103 a solicitat suspendarea autoriza\u0163iei pentru o serie de medicamente neconforme. C\u00e2te sunt \u00een Rom\u00e2nia"},"content":{"rendered":"<p><strong>\u00cen acord cu statele membre ale Uniunii Europene (UE) \u015fi \u00een urma unui aviz al Agen\u0163iei Europene a Medicamentului (EMA), Comisia European\u0103 a solicitat, vineri, statelor membre s\u0103 suspende autoriza\u0163ia de comercializare pentru o list\u0103 de medicamente generice testate de compania indian\u0103 Synapse Labs, din cauza dovezilor insuficiente cu privire la fiabilitatea datelor de testare.<\/strong><\/p>\n<p>Comitetul pentru medicamente de uz uman (CHMP), din cadrul Agen\u0163iei Europene a Medicamentului (EMA)\u00a0<a href=\"https:\/\/www.ema.europa.eu\/en\/medicines\/human\/referrals\/synapse\">\u015fi-a confirmat recomandarea<\/a>\u00a0de a suspenda sau de a nu acorda autoriza\u0163iile de introducere pe pia\u0163\u0103 pentru o serie de medicamente generice testate de Synapse Labs cu sediul \u00een India.<\/p>\n<p>Decizia se bazeaz\u0103 pe o evaluare \u015ftiin\u0163ific\u0103 efectuat\u0103 de EMA \u00een urma unei cereri din partea agen\u0163iei spaniole pentru medicamente.<\/p>\n<p>Aceasta din urm\u0103 a efectuat o inspec\u0163ie a laboratorului \u015fi a informat agen\u0163ia european\u0103 de reglementare, care a realizat o analiz\u0103, a anun\u0163at Comisia European\u0103 \u00eentr-un comunicat.<\/p>\n<p>\u201eUE dispune de un proces strict \u015fi riguros de aprobare a medicamentelor \u015fi de farmacovigilen\u0163\u0103, pentru a asigura cele mai \u00eenalte standarde pentru medicamentele din Uniunea European\u0103. \u00cen urma evalu\u0103rii sale \u015ftiin\u0163ifice, EMA a stabilit c\u0103 testele Synapse Labs privind aceste medicamente generice nu \u00eendeplineau cerin\u0163ele stricte ale UE \u00een materie de dovezi pentru a demonstra c\u0103 sunt echivalente cu medicamentele de referin\u0163\u0103. \u00cen acord cu statele membre ale UE, autoriza\u0163iile de comercializare na\u0163ionale vor fi suspendate p\u00e2n\u0103 c\u00e2nd produc\u0103torii vor putea furniza date valabile \u015fi fiabile pentru a demonstra echivalen\u0163a. Aceasta \u00eenseamn\u0103 furnizarea de date care s\u0103 demonstreze c\u0103 medicamentele generice elibereaz\u0103 \u00een organism aceea\u015fi cantitate de substan\u0163\u0103 activ\u0103 ca medicamentele de referin\u0163\u0103\u201d, precizeaz\u0103 sursa citat\u0103.<\/p>\n<p>\u00centre timp, \u00eens\u0103, pentru a se evita orice risc de penurie, autorit\u0103\u0163ile na\u0163ionale pot am\u00e2na suspendarea cu p\u00e2n\u0103 la 2 ani pentru medicamentele pe care le consider\u0103 de importan\u0163\u0103 critic\u0103 la nivel na\u0163ional, potrivit aceleia\u015fi surse.<\/p>\n<p>Perioade similare au fost acordate \u015fi \u00een trecut pentru a se asigura aprovizionarea cu medicamente esen\u0163iale.<\/p>\n<p>Produc\u0103torii vor avea astfel timp s\u0103 preg\u0103teasc\u0103 datele necesare \u015fi s\u0103 le transmit\u0103 spre evaluare.<\/p>\n<p>Aceast\u0103 perioad\u0103 de tranzi\u0163ie pune \u00een balan\u0163\u0103 necesitatea acestor date importante privind medicamentele comercializate \u00een UE \u015fi necesitatea unei aprovizion\u0103ri continue cu medicamente esen\u0163iale pentru pacien\u0163i.<\/p>\n<p>Pe lista publicat\u0103 de Comisia European\u0103 se afl\u0103 peste 45 de medicamente autorizate \u00een Rom\u00e2nia (pag. 154 \u2013 159).<\/p>\n<p>Comisia a precizat c\u0103 va continua s\u0103 urm\u0103reasc\u0103 \u00eendeaproape aceast\u0103 situa\u0163ie, \u00een cooperare cu toate statele membre.<\/p>\n<p>\u201eEMA \u015fi autorit\u0103\u0163ile na\u0163ionale vor continua s\u0103 colaboreze \u00eendeaproape pentru a se asigura c\u0103 studiile privind medicamentele din UE sunt efectuate la cele mai \u00eenalte standarde \u015fi c\u0103 societ\u0103\u0163ile respect\u0103 toate aspectele legate de bunele practici clinice. \u00cen cazul \u00een care companiile nu respect\u0103 standardele impuse, autorit\u0103\u0163ile vor lua m\u0103surile necesare pentru a asigura integritatea datelor utilizate pentru aprobarea medicamentelor din UE\u201d.<\/p>\n<p>CHMP\u00a0a adoptat recomandarea ini\u0163ial\u0103\u00a0\u00een decembrie 2023, dup\u0103 o inspec\u0163ie privind bunele practici clinice (BPC) care a ar\u0103tat nereguli \u00een datele studiilor \u015fi inadecv\u0103ri \u00een documenta\u0163ia studiilor \u015fi \u00een sistemele \u015fi procedurile informatice de gestionare a datelor studiilor. Acest lucru a generat \u00eengrijor\u0103ri serioase cu privire la datele din studiile de bioechivalen\u0163\u0103 efectuate de laboratorul din India.<\/p>\n<p>Cite\u0219te mai mult <a href=\"https:\/\/www.news.ro\/social\/sanatate\/comisia-europeana-a-solicitat-statelor-membre-sa-suspende-autorizatia-pentru-o-serie-de-medicamente-generice-neconforme-intre-acestea-peste-45-sunt-autorizate-in-romania-1922400026002024052321606250\">AICI<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>\u00cen acord cu statele membre ale Uniunii Europene (UE) \u015fi \u00een urma unui aviz al Agen\u0163iei Europene a Medicamentului (EMA), Comisia European\u0103 a solicitat, vineri, statelor membre s\u0103 suspende autoriza\u0163ia de comercializare pentru o list\u0103 de medicamente generice testate de compania indian\u0103 Synapse Labs, din cauza dovezilor insuficiente cu privire la fiabilitatea datelor de testare. [&hellip;]<\/p>\n","protected":false},"author":34,"featured_media":134450,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_eb_attr":"","_themeisle_gutenberg_block_has_review":false,"footnotes":""},"categories":[1],"tags":[45384,45385,139,11270],"ppma_author":[35604],"class_list":["post-143092","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-actualitate","tag-agentiei-europene-a-medicamentului","tag-chmp","tag-comisia-europeana","tag-uniunii-europene"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v24.6 (Yoast SEO v24.6) - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>Comisia European\u0103 a solicitat suspendarea autoriza\u0163iei pentru o serie de medicamente neconforme. 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