Health Canada has further increased it's scope of submissions that are accepted in eCTD-only format. In addition to the announcement in May this year (see our previous News...[mehr]
Health Canada has released the revised draft guidance "Preparation of Drug Submissions and Applications in the Common Technical Document (CTD) Format" for consultation...[mehr]
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....[mehr]
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...[mehr]
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...[mehr]
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....[mehr]
Health Canada announced that the pilot phase for the hybrid filing format (eCTD submissions, accompanied by partial paper-based submission) has been completed. Since...[mehr]
