Archived - Consultation on the Revised Guidance for Industry Preparation of the Quality Information for Drug Submissions in the CTD Format: Biotherapeutic and Blood Products

Notice to Stakeholders

Health Canada is pleased to announce the release of the following documents for a 90-day comment period:

1. Guidance for Industry Preparation of the Quality Information for Drug Submissions in the CTD Format: Biotherapeutic and Blood Products, which merges the three CTD (Common Technical Document) Guidance documents applicable to Conventional Biotherapeutic Products, Biotechnological/biological (Biotech) Products and Blood Products .
   • The guidance is modernized by replacing outdated information (e.g., organizational structure, guidance documents) and clarifying what needs to be provided under each CTD section to reflect our current expectations.
   • The guidance remains aligned with the CTD structure described in ICH M4Q entitled The Common Technical Document for the Registration of Pharmaceuticals for Human Use (2002).
2. A Quality Overall Summary – Biologics (QOS-B) template specific to biologics is available for (optional) use
   • To ensure that data gaps found with the use of the Therapeutic Product Directorate’s Quality Overall Summary – Chemical Entities (QOS-CE) template for biologics’ drug submission filings in the past are minimized.
   • To expedite the Biologic and Radiopharmaceutical Drugs Directorate’s review process.
3. The Certified Product Information Document – Biologics (CPID-B) template is updated to be in line with the revised Guidance for Industry [1) above] and to provide additional guidance for the implementation of the International Council for Harmonization (ICH) Q12 guideline in Canada.

Health Canada invites all stakeholders to provide written submissions in response to formal consultations, which will be summarized in reports, such as a Summary of Comments and a What We Heard Report. Health Canada makes these reports publicly available.

Please email brddopic-bpcidmbr@hc-sc.gc.ca to receive the consultation documents.

How to Get Involved

This consultation is open for a 90-day period from January 24, 2022 to April 26, 2022.  Interested parties are invited to email comments to brddopic-bpcidmbr@hc-sc.gc.ca using the template provided. All comments will be considered in the finalization of the documents. 

Contact Information

Centre for Policy, Pediatrics and International Collaboration
Biologic and Radiopharmaceutical Drugs Directorate
Health Products and Food Branch
Health Canada
brddopic-bpcidmbr@hc-sc.gc.ca