The Summary Basis of Decision document outlines the scientific and benefit/risk-based considerations that factored into Health Canada’s decision to grant market authorization for a drug or medical device. The document includes regulatory, safety, efficacy, and quality (chemistry and manufacturing) considerations and reflects the information within the regulatory review reports.

Health Canada is undertaking an evaluation of phase I of the Summary Basis of Decision initiative. As part of this evaluation, we are asking stakeholders to complete this workbook and submit it to OBT_enquiries@hc-sc.gc.ca by May 15, 2009.

How to Get Involved

The consultation workbook can be completed and submitted on-line starting April 7, 2009 until May 15, 2009 inclusive.

Consultation Workbook

Interested stakeholders are encouraged to complete and submit the consultation workbook by May 15, 2009.