{"id":56269,"date":"2015-04-07T15:06:20","date_gmt":"2015-04-07T15:06:20","guid":{"rendered":"http:\/\/mostafa.openonline.co.uk\/?guid=7572247eee59e72160be741da0f701bb"},"modified":"2015-04-07T15:06:20","modified_gmt":"2015-04-07T15:06:20","slug":"news-story-mandatory-use-of-ectd-for-decentralised-procedures","status":"publish","type":"post","link":"https:\/\/mostafa.openonline.co.uk\/?p=56269","title":{"rendered":"News story: Mandatory use of eCTD for decentralised procedures"},"content":{"rendered":"<div class=\"govspeak\">\n<p>Marketing authorisation (<abbr title=\"Marketing authorisation\">MA<\/abbr>) applications submitted to <abbr title=\"Medicines and Healthcare products Regulatory Agency\">MHRA<\/abbr> in non-<abbr title=\"electronic common technical document\">eCTD<\/abbr> electronic submissions (<abbr title=\"non-eCTD electronic submissions\">NeeS<\/abbr>) will be rejected. Around 90% of new applications for decentralised procedures (<abbr title=\"decentralised procedures\">DCP<\/abbr>) received by <abbr title=\"Medicines and Healthcare products Regulatory Agency\">MHRA<\/abbr> are already submitted in <abbr title=\"electronic common technical document\">eCTD<\/abbr> format.<\/p>\n<p>Along with other national competent authorities (<abbr title=\"national competent authorities\">NCAs<\/abbr>) we intend to make this change mandatory in line with the EU roadmap, which has been progressed in consultation with industry, trade bodies and other <abbr title=\"national competent authorities\">NCAs<\/abbr>.  <\/p>\n<p>Further information about the consultation can be found on the <a rel=\"external\" href=\"http:\/\/esubmission.ema.europa.eu\/tiges\/tigesdocuments.html\">European Medicines Agency website<\/a>.  <\/p>\n<p>New <abbr title=\"Marketing authorisation\">MA<\/abbr> applications in mutually recognised procedures will still be accepted in both <abbr title=\"non-eCTD electronic submissions\">NeeS<\/abbr> and <abbr title=\"electronic common technical document\">eCTD<\/abbr> formats, however applicants are encouraged to use <abbr title=\"electronic common technical document\">eCTD<\/abbr> format wherever possible as the use of the <abbr title=\"non-eCTD electronic submissions\">NeeS<\/abbr> format for these applications is planned to be phased out by 1 January 2017. <\/p>\n<\/div>\n","protected":false},"excerpt":{"rendered":"<p>From 1 July 2015, new market authorisation applications for decentralised procedures must be submitted in electronic common technical document (eCTD) format.<\/p>\n","protected":false},"author":8,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[13],"tags":[],"_links":{"self":[{"href":"https:\/\/mostafa.openonline.co.uk\/index.php?rest_route=\/wp\/v2\/posts\/56269"}],"collection":[{"href":"https:\/\/mostafa.openonline.co.uk\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/mostafa.openonline.co.uk\/index.php?rest_route=\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/mostafa.openonline.co.uk\/index.php?rest_route=\/wp\/v2\/users\/8"}],"replies":[{"embeddable":true,"href":"https:\/\/mostafa.openonline.co.uk\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=56269"}],"version-history":[{"count":0,"href":"https:\/\/mostafa.openonline.co.uk\/index.php?rest_route=\/wp\/v2\/posts\/56269\/revisions"}],"wp:attachment":[{"href":"https:\/\/mostafa.openonline.co.uk\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=56269"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/mostafa.openonline.co.uk\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=56269"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/mostafa.openonline.co.uk\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=56269"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}