Preparation of the Quality Information for Drug Submissions in the CTD Format: Biotechnological/ Biological (Biotech) Products: Guidance for Industry
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.
- Publisher
- Health Canada
- Resources
- 2
- Catalogue metadata updated
- 2023-09-03
Data overview
- Formats
- HTML
- File languages
- English, French
Official sources and licences
Resources
- Preparation of the Quality Information for Drug Submissions in the CTD Format: Biotechnological/ Biological (Biotech) Products: Guidance for Industry (English, HTML) HTML
- Preparation of the Quality Information for Drug Submissions in the CTD Format: Biotechnological/ Biological (Biotech) Products: Guidance for Industry (French, HTML) HTML