Health Canada has further increased it's scope of submissions that are accepted in eCTD-only format. A corresponding Notice has been released yesterday on Health Canada's website....[more]
Health Canada has released an updated version of their "Questions and Answers for the Guidance for Industry: Preparation of Drug Submissions in the Electronic Common...[more]
Health Canada has released an update regarding the scope of submissions currently accepted in eCTD format. Furthermore selected submission types will be accepted in eCTD-only...[more]
Health Canada announced the launch of the Notices of Change (Level III) Form in fillable PDF format to support the new guidance on Post-Notice of Compliance (NOC) Changes....[more]
Health Canada announced that the pilot phase for the hybrid filing format (eCTD submissions, accompanied by partial paper-based submission) has been completed. Since...[more]
Health Canada announced the availability of the final version of their eCTD guidance. The "Guidance for Industry: Preparation of Drug Submissions in Electronic Common...[more]