{"id":16804,"date":"2018-02-06T10:43:51","date_gmt":"2018-02-06T10:43:51","guid":{"rendered":"https:\/\/strammer.com\/?p=16804"},"modified":"2018-02-06T10:43:51","modified_gmt":"2018-02-06T10:43:51","slug":"ema-sur-brexit-revised-guidance-atmps","status":"publish","type":"post","link":"https:\/\/strammer.com\/en\/ema-sur-brexit-revised-guidance-atmps\/","title":{"rendered":"EMA survey on Pharma companies preparedness for BREXIT & revised guidance concerning the ATMPs"},"content":{"rendered":"
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EMA Faces BREXIT Challenges<\/span><\/h1>
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With the EMA<\/strong> changing<\/strong> locations from the UK<\/strong> to the Netherlands<\/strong>, many questions have been raised concerning pharmaceutical<\/strong> companies preparing<\/strong> for BREXIT<\/strong>.<\/p>\n

The EMA<\/strong> conducted a survey\u00a0<\/strong>on companies\u00a0<\/strong>and their preparedness<\/strong> for BREXIT<\/strong> to ensure medicine<\/strong> remain<\/strong> on the EU market<\/strong>. The survey’s purpose<\/strong> is to select<\/strong> the companies<\/strong> who need support<\/strong> concerning medicine supplies<\/strong> in order to protect<\/strong> human<\/strong> and animal<\/strong> health. Additionally, it was conducted to help the EMA<\/strong> and European<\/strong> Commission<\/strong> plan<\/strong> resources <\/strong>in the areas where these submissions will be processed. The survey<\/strong> will also help the EMA<\/strong> prepare for the move<\/strong>.<\/p>\n

Results<\/strong> show that there is a greater<\/strong> amount of centrally authorised products<\/strong> (CAPs) for human use than CAPs<\/strong> with UK-based marketing authorisation holders. This is also true<\/strong> for veterinary<\/strong> medicines<\/strong> with over 215 centrally authorised products for veterinary use and 22 CAPs<\/strong> with UK<\/strong>–based marketing authorisations holders<\/strong>. To\u00a0see the rest<\/strong> of the\u00a0findings\u00a0<\/strong>click here<\/a>\u00a0\u00a0<\/strong>(Ema.europa.eu, 2018).<\/span><\/p>\n

In January, 2018 the EMA<\/strong> updated<\/strong> its procedural advice<\/strong> on the evaluation<\/strong> of Advanced Therapy Medicinal Products<\/strong> (ATMPs). The EMA is working to improve<\/strong> and facilitate<\/strong> development<\/strong> and patient<\/strong> access<\/strong> to these innovative medicines <\/strong>at a cheaper cost<\/strong>. The update of the guidance strengthens collaboration<\/strong> between EMA’s<\/strong> scientific<\/strong> committees<\/strong> and addresses<\/strong> specific needs of ATMP<\/strong> developers in the evaluation<\/strong> procedure. A presentation<\/a><\/strong> of the process provides an overview of the points raised regarding the Procedural Advice on the Evaluation of ATMPs<\/strong> and what is new<\/strong> in the updated version.<\/strong><\/p>\n

To conclude, the revised<\/strong> guidelines are a step forward<\/strong> in the support<\/strong> of the ATMP<\/strong> developers<\/strong>. It ensures safety<\/strong> and encourages<\/strong> ATMPs<\/strong> to plan timely interactions with EMA<\/strong> and ensure an efficient<\/strong> development<\/strong> process<\/strong>.<\/p>\n

Resources:<\/span><\/p>\n

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  1. http:\/\/www.ema.europa.eu\/docs\/en_GB\/document_library\/Presentation\/2018\/02\/WC500242958.pdf<\/a><\/span><\/li>\n
  2. http:\/\/www.ema.europa.eu\/ema\/index.jsp?curl=pages\/news_and_events\/news\/2018\/01\/news_detail_002890.jsp&mid=WC0b01ac058004d5c1<\/a><\/span><\/li>\n<\/ol>","protected":false},"excerpt":{"rendered":"","protected":false},"author":7,"featured_media":16825,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_editorskit_title_hidden":false,"_editorskit_reading_time":0,"_editorskit_is_block_options_detached":false,"_editorskit_block_options_position":"{}","myguten_meta_block_field":"","footnotes":""},"categories":[98],"tags":[],"class_list":["post-16804","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-news"],"acf":[],"_links":{"self":[{"href":"https:\/\/strammer.com\/en\/wp-json\/wp\/v2\/posts\/16804","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/strammer.com\/en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/strammer.com\/en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/strammer.com\/en\/wp-json\/wp\/v2\/users\/7"}],"replies":[{"embeddable":true,"href":"https:\/\/strammer.com\/en\/wp-json\/wp\/v2\/comments?post=16804"}],"version-history":[{"count":0,"href":"https:\/\/strammer.com\/en\/wp-json\/wp\/v2\/posts\/16804\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/strammer.com\/en\/wp-json\/wp\/v2\/media\/16825"}],"wp:attachment":[{"href":"https:\/\/strammer.com\/en\/wp-json\/wp\/v2\/media?parent=16804"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/strammer.com\/en\/wp-json\/wp\/v2\/categories?post=16804"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/strammer.com\/en\/wp-json\/wp\/v2\/tags?post=16804"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}