Summary Basis of Decision - Background
Project Development: 2003-2004
Health Canada developed the Summary Basis of Decision (SBD) project in response to Health Canada's commitment to enhance the transparency of the drug and medical device regulatory review processes. Project development began in 2003/04 and included a large stakeholder consultation that was held in June 2004, where interested parties including industry and patient and consumer groups provided input into the direction of the SBD initiative.
- Draft Issue Analysis Summary - A discussion document in support of the consultation workshop June 10-11, 2004 [2004-05-25]
- External Consultation Report - June 10-11, 2004 [2004-09-20]
Phase I: 2005 - June 2012
The first phase of the SBD project started on January 1, 2005 with the publication of Notice of Decision and Summary Basis of Decision documents for 'novel' drugs and devices: New Drug Submissions for New Active Substances and a subset of Class IV medical device applications.
Phase I Notice of Decision (ND) documents are one- to two-page summaries that inform the public of Health Canada's decision to authorize the product, and provide some general information about the drug or medical device.
SBDs are detailed documents that describe the scientific and benefit/risk analysis that factored into Health Canada's decision to authorize the sale of a drug or medical device. The documents include regulatory, safety, efficacy, and quality (chemistry and manufacturing) considerations.
Health Canada uses the following templates to produce Notice of Decision and Summary Basis of Decision documents in Phase I:
- Phase I Notice of Decision Template: Medical Devices [2009-08-04]
- Phase I Notice of Decision Template: Drugs [2009-08-04]
- Phase I Summary Basis of Decision Template: Medical Devices [2009-08-04]
- Phase I Summary Basis of Decision Template: Drugs [2009-08-04]
Evaluation of Phase I: 2008-2009
In 2008-2009, Health Canada conducted an evaluation of the first phase of the SBD project. Information was collected and analyzed for the period of January 1, 2005 to September 30, 2008, during which time a total of 197 NDs and SBDs were published. The results of the evaluation are posted below.
Consultation for Phase II: 2011
Health Canada consulted externally on our proposals for phase II of the SBD project late in 2011.
The consultation report is posted below.
Health Canada has now launched Phase II of the Summary Basis of Decision project. Phase II will be effective immediately, with the publication of the Notice and the accompanying Frequently Asked Questions document and Phase II Reader's Guide - Drugs ; and Phase II Reader's Guide - Medical Devices on June 29, 2012. Phase II SBDs will be drafted for all eligible drugs and medical devices authorized/licensed as of September 1, 2012. Eligible products authorized before September 1, 2012, but on or after January 1, 2005 will have SBDs in the Phase I format. Please note: with Phase II, the Notice of Decision will be eliminated.
External Consultation Report 2016
The purpose of this report is to provide a summary of the results of the on-line questionnaire. The subject of the questionnaire was health product transparency initiatives.
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