Preparation of the Quality Information for Drug Submissions in the CTD Format: Biotechnological/ Biological (Biotech) Products: Guidance for Industry

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This document is intended to provide Industry with guidance for the preparation of drug submissions for Biotechnological/ Biological Products. It is structured using the International Council for Harmonisation (ICH) Common Technical Document (CTD) format. Throughout this document, this group of products is referred to as “Biotech”, for short.

This document supplements the ICH Harmonised Tripartite Guidance, The Common Technical Document, Module 2.3: Quality Overall Summary (QOS) and Module 3: Quality, the ICH Common Technical Document – Quality Questions and Answers/ Location Issues, as well as the Health Canada Guidance documents for Industry on the preparation of various types of drug submissions in the CTD format.

This document also references other domestic Quality guidance documents that can be useful in preparing the technical or scientific information required for certain sections of the submission.

For additional guidance in preparing the drug submission, applicants should consult the Office of Regulatory Affairs (ORA) and the appropriate division of the Centre for Biologics Evaluation (CBE) or the Centre for Evaluation of Radiopharmaceuticals and Biotherapeutics (CERB), within the Biologics and Genetic Therapies Directorate (BGTD). The applicant is also advised to consult for the latest information (e.g. Notices).

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