Posted 02 April 2012
By Ansis Helmanis, RegLink
Health Canada issued Draft Guidance on 30 March on the Preparation of Drug Regulatory Activities in electronic Common Technical Documents (eCTDs). The guidance, which provides more options for sponsors of submissions, is effective immediately since it does not impose any new obligations. The exception to immediate effect-section 3.4.1 Module 1: Administrative and Product Information-will only be usable when the revised Canadian Module 1 Schema is published and adopted.
Consultation Document - Draft Guidance Document: Preparation of Drug Regulatory Activities in Electronic Common Technical Document (eCTD)