Health Canada announced a request for sponsor participation in a pilot project for clinical trial regulatory activities in electronic common technical document (eCTD) format. Prior to filing a Clinical Trial regulatory transaction in eCTD format, each company must file a sample transaction to Health Canada in accordance with the eCTD guidance document. Now Health Canada will accept dossiers in eCTD format only from 01 … Health Canada is pleased to announce the release of the Draft Guidance for Industry: Creation of the Canadian Module 1 Backbone for a 30 day consultation period. In a notice posted to its website, Health Canada gave advance warning that the agency is considering an eCTD filing requirement, or eCTD mandate, that would take effect as early as January 1, 2018.. Health Canada is asking for stakeholders to submit comments by August 31, 2016. eCTD facilitates the quick creation and review of electronic data with a flexibility to … Publication. We also provide comprehensive training seminars for companies just getting started with electronic submissions to those with existing levels of expertise. HEALTH CANADA GUIDANCE DOCUMENTS: Date Published: Validation rules for regulatory transactions submitted to Health Canada in (eCTD) format; August 21st, 2015: Preparation of Drug Regulatory Activities in the eCTD Format; May 14th, 2015: Preparation of Drug Regulatory Activities in the “Non-eCTD Electronic-Only” Format; Sept 25th,2015 Refer to section “2.4 Dossier ID Request Process” of the REP guidance document, and REP Video Tutorial #3 below for details regarding the Dossier ID process. Comments can be sent to ereview@hc-sc.gc.ca.. With Onix‘s years of experience, we are well-positioned to advise your company on best practices for a successful submission. A “must” to be studied before you start with eCTD in EU is the “Harmonised Technical Guidance for eCTD Submissions in the EU“. ICH M4Q reached Step 4 in September 2002 Adopted by Health Canada in 2003 2 Upon completion, the form is auto-sent via email the Health Canada, outside of the regulatory transaction (submission). Health Canada recommends a Pre-technical meeting for companies using eCTD for the first time. As of June 1, 2019, the remainder of Division 8 regulatory activity types (human drugs only) must be submitted in eCTD format. The eCTD format was made available following a Health Canada pilot … Health Canada’s objective with this initiative is to make anonymized clinical information in drug submissions and medical device applications publicly available for non-commercial purposes to enable re-analyses of data, foster new research questions, and help Canadians to make more informed decisions regarding their health. As per the CanadaFDA, the CanadaFDR, the G-CanadaCTApps, and CAN-29, Health Canada (HC) is the competent authority responsible for clinical trial approvals, oversight, and inspections in Canada. About eCTD Insights This site and related information regarding eCTD are provided by EXTEDO. Health Canada published a Guidance Document in 2014 on the preparation of drug regulatory activities in eCTD format. 61 62 This document should be read in conjunction with the accompanying notice and the relevant 139 140 141 Once Health Canada finds the eCTD sample acceptable, companies can request a Dossier Identifier (e123456) via the Dossier Request Form for Clinical Trials dossiers, available on the Filing Submissions Electronically page. Furthermore, in order to submit data, Health Canada will only support recordable CDs and DVDs which it requires to be labeled with sponsor and brand name, eCTD identifier and sequence number (where applicable), date of filing and verification of virus-free status. Once final, it will replace the 2004 Guidance for Industry: Creation of the Canadian Module 1 eCTD Backbone File. Health Canada eCTD Update. Since 2015, Health Canada is an official member to the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). From March 30th, 2019 Health Canada revised validation rules for regulatory transactions in the electronic Common technical Document (eCTD) format. Overview eCTD (electronic Common Technical Document) is an electronic format that supports the submission of applications, amendments, supplements and reports to the United States Food and Drug Administration (USFDA), European Medicines Agency (EMA) and other Health Authorities (HAs) worldwide.