The following are recent Health Canada links relating to eCTD and Drug licensing. The list is not complete as it was created for our own use but it will be updated frequently. If the list is helpful, you can bookmark it. You are welcome to use the links for your projects . We will try to update the list as often as is possible. Health Canada updates

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
Amendments to the Food and Drugs Act: Guide to New Authorities	July 31st, 2015
Post-Notice of Compliance (NOC) Changes: Safety and Efficacy Document	June 13th, 2015
Guidance Document: Drug Submissions Relying on Third-Party Data (Literature and Market Experience)	May 1st,2015
Updates to the Guidance Document: Post-Notice of Compliance (NOC) Changes: Safety and Efficacy to reflect Plain Language Labelling Regulations	August 26, 2015
Non-prescription Oral Adult Decongestant Cough and Cold Labelling Standard	June 1st , 2015
Common Electronic Submissions Gateway	2014
Frequently Asked Questions – Common Electronic Submissions Gateway	2014
Final Guidance Document: Schedule A / Section 3 to the Food and Drugs Act	Dec 20th, 2013
Release of Health Canada’s Revisions to“1.6 Electronic Review Documents” in Draft	Feb 25th, 2008
Guidance Document: Creation of the Canadian Module 1 Backbone	Sept 7th,2012
Guidance Document: Preparation of Drug Regulatory Activities in the Common Technical Document (CTD) Format t	June 22nd,2012
Guidance for Industry: Preparation of New Drug Submissions in the CTD Format	June 22nd,2012
PREPARATION OF DRUG IDENTIFICATION NUMBER SUBMISSIONS CLINICAL TRIALS	Feb 22nd, 1995
Guidance Document for Clinical Trial Sponsors: Clinical Trial Applications	May 29th, 2013
Revision to an administrative practice regarding the acknowledgement of receipt of Clinical Trial Application Notifications received in the Office of Clinical Trials of the Therapeutic Products Directorate	July 30th, 2014
Electronic Specifications for Clinical Trial Applications and Amendments filed in accordance with Guidance Document for Clinical Trial Sponsors: Clinical Trial Applications	May 29th, 2013
Templates	2015-2004

Canadian Module 1 Schema Version 2.2	October 16, 2015
Quality Overall Summary – Chemical Entities Clinical Trial Application – Phase II	j
Quality Overall Summary – Chemical Entities Clinical Trial Application – Phase III	k
Guidance Document for Clinical Trial Sponsors: Clinical Trial Applications	l
Guidance E6: Good Clinical Practice: Consolidated guideline PHARMACOVIGILANCE
Good Pharmacovigilance Practices (GVP)Guidelines GUI 0102	Feb 11th, 2013
Inspection Strategy for Good Pharmacovigilance Practices (GVP)for Drugs	Feb 11th, 2013
Health Products and Food Branch Inspectorate Risk Classification of Good Pharmacovigilance Practices (GVP)Observations	Feb 11th, 2013

Guidance Document: Creation of the Canadian Module 1 Backbone	Sept 7th,2012


Frequently Asked Questions – Common Electronic Submissions Gateway	1
Canadian Module 1 Schema Version 2.2	2
Guidance Document: Creation of the Canadian Module 1 Backbone	3
Preparation of Drug Regulatory Activities in the “Non-eCTD Electronic-Only” Format	4
Common Electronic Submissions Gateway	5
GUIDANCE DOCUMENT	6
Validation rules for regulatory transactions submitted to Health Canada in (eCTD) format	7
Preparation of Drug Regulatory Activities in the eCTD Format	8
Frequently Asked Questions – Common Electronic Submissions Gateway	9
Canadian Module 1 Schema Version 2.2	10
Guidance Document: Creation of the Canadian Module 1 Backbone	11
Preparation of Drug Regulatory Activities in the “Non-eCTD Electronic-Only” Format	12

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