Please refer to Question 12 for clarification about information available about negative decisions made for an already approved-product after the SBD is published.
Interested parties can seek information related to a previously authorized drug submission or medical device licence application by making a request under the .
In Phase II, Health Canada will no longer produce NDs, in order that SBDs may be produced in a more timely manner.
However, the information formerly provided in the ND will continue to be published as part of the Phase II SBD.
SBDs are written for all Canadians interested in the reasons why Health Canada has taken product-specific decisions for drugs and medical devices.
A Summary Basis of Decision (SBD) document outlines the scientific and benefit/risk-based considerations that factor into Health Canada's decision to grant market authorization for a drug or medical device.
The document summarizes Health Canada's risk/benefit analysis and includes regulatory, safety, efficacy, and quality considerations identified within Health Canada's regulatory review reports.
After careful consideration of the evaluation of Phase I of the SBD initiative and the results of internal and external consultations, Health Canada is now moving into Phase II of the SBD initiative (link to the launch Notice).
The following changes will be made as part of the launch of Phase II: Phase II is being launched in June 2012 with the publication of a Notice (link to Notice).