Summary Basis of Decision (SBD)
The Summary Basis of Decision project was developed in response to Health Canada's commitment to enhance the transparency of the drug and medical device regulatory review process.
A Summary Basis of Decision is a document that outlines the scientific and benefit/risk based decisions that factor 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. Summary Basis of Decisions will be implemented in a phased approach beginning with New Drug Submissions for New Active Substances and a subset of Class IV medical device applications.
For up-to-date information on a particular product, readers should refer to the most recent Product Monograph or Operator's Manual for a product. For information related to post-market warnings or advisories as a result of adverse events,
visit the MedEffect section of this site.
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