Healtch Canada: Revised Draft Guidance Document: Preparation of Drug Submissions and Applications in the Common Technical Document (CTD) Format.

Healtch Canada: Revised Draft Guidance Document: Preparation of Drug Submissions and Applications in the Common Technical Document (CTD) Format.

Health Canada is pleased to announce the release of the revised draft Guidance for Industry:Preparation of Drug Submissions and Applications in the Common Technical Document (CTD)Format for a 60-day comment period. Once final, it will replace the 2003 Draft Guidance for Industry: Preparation of New Drug Submissions in the CTD Format.

This guidance document will assist sponsors in the preparation of drug submissions and applications in the Common Technical Document (CTD) format developed by the International Conference on Harmonisation (ICH). It defines the regional requirements of submissions in CTD format, found in Modules 1 and 3.

please click here to find more information: Healtch Canada: Revised Draft Guidance Document: Preparation of Drug Submissions and Applications in the Common Technical Document (CTD) Format.