What is industrys involvement in terms of the content of the SBDs?
The development of the SBDs is independent of industry. Industry will be provided a draft of the completed document with an opportunity to comment on the proprietary nature of any material therein as well as any perceived inaccuracies in data. Health Canada will then review all comments received and make revisions as appropriate and necessary. • Will Health Canada update the SBDs to include post-market information or new uses as they are approved? No. The SBDs will be frozen to reflect the information that supported the original decision to authorize the product. Subsequent submissions reviewed for additional uses (Supplemental Drug Submissions or Application for a Medical Device Licence Amendment) will not be captured under Phase I of the SBD implementation strategy, but will be captured under Phase II. Readers seeking post-market information should also consult the Marketed Health Products Directorate website. • Of what benefit is the SBD to consumers, patient groups and health profe
