News Archiv

Health Canada further increases scope of submissions beeing accepted in eCTD-only format

25.05.2011
Flag of Canada

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]

[more]

CA: Health Canada updates Q&A for the preparation of eCTD submissions

08.12.2010
Flag of Canada

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]

[more]

CA: Update from Health Canada regarding scope of submissions being accepted in eCTD format and acceptance of electronic-only submissions

24.08.2010
Flag of Canada

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]

[more]

CA: Health Canada publishes information about filing of Post-Notice of Compliance changes in eCTD format

18.06.2010
Flag of Canada

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]

[more]

CA: Health Canada announces completion of pilot phase for hybrid filing format

28.01.2010

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]

[more]

CA: Health Canada releases the final version of their eCTD guidance

04.11.2009

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]

[more]

© 2007 - 2011 | Exalon GmbH | Fritz-Reichle-Ring 8 | 78315 Radolfzell | Germany | Phone: +49 (0)7732.939.1650 | Fax: -.1655 | e-Mail:info@exalon.com