{"id":3531,"date":"2023-06-19T13:51:22","date_gmt":"2023-06-19T12:51:22","guid":{"rendered":"https:\/\/www.onixls.com\/?p=3531"},"modified":"2023-09-19T13:52:42","modified_gmt":"2023-09-19T12:52:42","slug":"ectd-industry-update-19th-june-2023","status":"publish","type":"post","link":"https:\/\/www.onixls.com\/2023\/06\/ectd-industry-update-19th-june-2023\/","title":{"rendered":"eCTD Industry Update (19th June 2023)"},"content":{"rendered":"<p><b><u>EMA<\/u><\/b><\/p>\n<ul type=\"disc\">\n<li class=\"gmail-MsoListParagraph\"><a href=\"https:\/\/www.ema.europa.eu\/en\/events\/clinical-trials-information-system-ctis-information-day\" target=\"_blank\" rel=\"noopener\">Clinical Trials Information System (CTIS): Information day<\/a>\u00a0, Online, 13:30- 17:30 Amsterdam time (CET), from 17\/10\/2023 to 17\/10\/2023<\/li>\n<li class=\"gmail-MsoListParagraph\"><a href=\"https:\/\/www.ema.europa.eu\/en\/events\/eudravigilance-signal-management-information-day-0\" target=\"_blank\" rel=\"noopener\">EudraVigilance and Signal Management information day<\/a>\u00a0, European Medicines Agency, Amsterdam, the Netherlands, 09:30-17:00 CET, from 21\/11\/2023 to 21\/11\/2023<\/li>\n<li class=\"gmail-MsoListParagraph\"><a href=\"https:\/\/www.ema.europa.eu\/documents\/other\/european-medicines-agency-practical-guidance-application-form-centralised-type-ia-ib-variations_en.pdf\" target=\"_blank\" rel=\"noopener\">E<\/a><a href=\"https:\/\/www.ema.europa.eu\/documents\/other\/european-medicines-agency-practical-guidance-application-form-centralised-type-ia-ib-variations_en.pdf\" target=\"_blank\" rel=\"noopener\">uropea<\/a><a href=\"https:\/\/www.ema.europa.eu\/documents\/other\/european-medicines-agency-practical-guidance-application-form-centralised-type-ia-ib-variations_en.pdf\" target=\"_blank\" rel=\"noopener\">n Medicines Agency practical guidance on the application form for centralised type IA and IB variations<\/a>\u00a0(updated)<\/li>\n<\/ul>\n<p><a href=\"https:\/\/www.ema.europa.eu\/documents\/other\/policy-43-european-medicines-agency-policy-access-documents_en.pdf\" target=\"_blank\" rel=\"noopener\"><b>eSubmissions (eCTD<\/b><\/a>)<\/p>\n<p><u>Updated version of the eAF v1.26.0.0 (human variation)<\/u><\/p>\n<p>An updated version 1.26.0.0 of the human variation eAFs is available starting with 14 June 2023.<\/p>\n<p>A single change has been implemented to address a non-blocking regression bug (related to the declaration on the manufacturers and MAH).<\/p>\n<p>It is recommended to use this latest form for new submissions (document properties date 14.06.2023). Please note that there is no version number change and that the release notes are not published for this minor change at this time.<\/p>\n<p><u>Updated PLM Portal eAF Release notes now available<\/u><\/p>\n<p>An updated version of the\u00a0<a href=\"https:\/\/esubmission.ema.europa.eu\/cessp\/PLM%20Portal%20-%20Release%20Notes.pdf\" target=\"_blank\" rel=\"noopener\">PLM Portal eAF Release notes<\/a>\u00a0reflecting bug fixes and updates to web eAF made in the version 1.0.1.9 released to production on the 12 of June 2023 are now available on\u00a0<a href=\"https:\/\/plm-portal.ema.europa.eu\/forums\/whats-new\" target=\"_blank\" rel=\"noopener\">PLM Portal Forum<\/a>\u00a0and on the PLM Portal eAF web page.<\/p>\n<p><b><u>MHRA<\/u><\/b><\/p>\n<ul type=\"disc\">\n<li class=\"gmail-MsoListParagraph\"><a href=\"https:\/\/www.gov.uk\/guidance\/regulating-medical-devices-in-the-uk\" target=\"_blank\" rel=\"noopener\"><b>Regulati<\/b><\/a><a href=\"https:\/\/www.gov.uk\/guidance\/regulating-medical-devices-in-the-uk\" target=\"_blank\" rel=\"noopener\"><b>ng <\/b><\/a><a href=\"https:\/\/www.gov.uk\/guidance\/regulating-medical-devices-in-the-uk\" target=\"_blank\" rel=\"noopener\"><b>medical<\/b><\/a><a href=\"https:\/\/www.gov.uk\/guidance\/regulating-medical-devices-in-the-uk\" target=\"_blank\" rel=\"noopener\"><b> devices in the UK<\/b><\/a> &#8211; 16 June 2023 &#8211; Guidance<\/li>\n<li class=\"gmail-MsoListParagraph\"><a href=\"https:\/\/www.gov.uk\/guidance\/guidance-on-150-day-assessment-for-national-applications-for-medicines\" target=\"_blank\" rel=\"noopener\"><b>150-day<\/b><\/a><a href=\"https:\/\/www.gov.uk\/guidance\/guidance-on-150-day-assessment-for-national-applications-for-medicines\" target=\"_blank\" rel=\"noopener\"><b> a<\/b><\/a><a href=\"https:\/\/www.gov.uk\/guidance\/guidance-on-150-day-assessment-for-national-applications-for-medicines\" target=\"_blank\" rel=\"noopener\"><b>ssessm<\/b><\/a><a href=\"https:\/\/www.gov.uk\/guidance\/guidance-on-150-day-assessment-for-national-applications-for-medicines\" target=\"_blank\" rel=\"noopener\"><b>ent for national applications for medicines<\/b><\/a> &#8211; 15 June 2023 &#8211; Guidance<\/li>\n<\/ul>\n<p><b><u>Health Canada\u00a0<\/u><\/b><\/p>\n<ul type=\"disc\">\n<li class=\"gmail-MsoListParagraph\"><a href=\"https:\/\/www.canada.ca\/en\/health-canada\/services\/drugs-health-products\/drug-products\/applications-submissions\/guidance-documents\/common-technical-document\/updated-guidance-document-preparation-regulatory-activities-non-ectd-electronic-only-format.html\" target=\"_blank\" rel=\"noopener\">Update:<\/a> <a href=\"https:\/\/www.canada.ca\/en\/health-canada\/services\/drugs-health-products\/drug-products\/applications-submissions\/guidance-documents\/common-technical-document\/updated-guidance-document-preparation-regulatory-activities-non-ectd-electronic-only-format.html\" target=\"_blank\" rel=\"noopener\">Guidanc<\/a><a href=\"https:\/\/www.canada.ca\/en\/health-canada\/services\/drugs-health-products\/drug-products\/applications-submissions\/guidance-documents\/common-technical-document\/updated-guidance-document-preparation-regulatory-activities-non-ectd-electronic-only-format.html\" target=\"_blank\" rel=\"noopener\">e document: preparation of regulatory activities in non-eCTD format<\/a><\/li>\n<li class=\"gmail-MsoListParagraph\"><a href=\"https:\/\/www.canada.ca\/en\/health-canada\/services\/drugs-health-products\/medical-devices\/activities\/announcements\/regulatory-enrolment-process-medical-devices-regulatory-activities-notice.html\" target=\"_blank\" rel=\"noopener\">Imple<\/a><a href=\"https:\/\/www.canada.ca\/en\/health-canada\/services\/drugs-health-products\/medical-devices\/activities\/announcements\/regulatory-enrolment-process-medical-devices-regulatory-activities-notice.html\" target=\"_blank\" rel=\"noopener\">me<\/a><a href=\"https:\/\/www.canada.ca\/en\/health-canada\/services\/drugs-health-products\/medical-devices\/activities\/announcements\/regulatory-enrolment-process-medical-devices-regulatory-activities-notice.html\" target=\"_blank\" rel=\"noopener\">nting<\/a><a href=\"https:\/\/www.canada.ca\/en\/health-canada\/services\/drugs-health-products\/medical-devices\/activities\/announcements\/regulatory-enrolment-process-medical-devices-regulatory-activities-notice.html\" target=\"_blank\" rel=\"noopener\"> the regulatory enrolment process (REP) for medical devices regulatory activities: Notice<\/a><\/li>\n<\/ul>\n","protected":false},"excerpt":{"rendered":"<p>EMA Clinical Trials Information System (CTIS): Information day\u00a0, Online, 13:30- 17:30 Amsterdam time (CET), from 17\/10\/2023 to 17\/10\/2023 EudraVigilance and Signal Management information day\u00a0, European Medicines Agency, Amsterdam, the Netherlands, 09:30-17:00 CET, from 21\/11\/2023 to 21\/11\/2023 European Medicines Agency practical guidance on the application form for centralised type IA and IB variations\u00a0(updated) eSubmissions (eCTD) Updated [&hellip;]<\/p>\n","protected":false},"author":2,"featured_media":2199,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[5],"tags":[7,11,37,30],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v19.10 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>eCTD Industry Update 19th June 2023 | Onix Life Sciences<\/title>\n<meta name=\"description\" content=\"ONIX aims to inform our customers of any eCTD industry updates weekly. 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