In order to continue enhancing the transparency of the drug review process, the Ministry of Health and Long-Term Care is publicly posting the status of manufacturers’ drug submissions.  The purpose of this transparency initiative is to allow industry stakeholders and the public to track the status of drug submissions through the various stages of the review cycle.

The Ministry posts drug submission status for single-source (generally brand name) submissions, and complete streamlined multiple-source (generally generic) submissions.  Posting of status for other submission types (e.g. non-streamlined multiple-source submissions) may be considered in the future depending on stakeholder interest and Ministry resources.

The posting of drug submission status was first implemented in June 2008, which included single-source drug submissions undergoing first review received on June 1, 2008 and streamlined multiple-source drug submissions for Formulary listing received by the June 4, 2008 deadline.

Commencing in February 2009, postings of complete streamlined multiple-source submissions for Off-Formulary Interchangeability considerations became available.  At the same time, submissions for diabetic test strips were added to the single-source submission postings.

Since July 2011, the postings have included status of single-source drug submissions undergoing subsequent reviews.

The status of single-source submissions is updated on a bi-weekly basis. The posting for streamlined multiple-source submissions is updated monthly.

• Status of Single-Source Submissions
• Complete Streamlined Multiple-Source Submissions for Future Formulary Listing
• Complete Streamlined Multiple-Source Submissions for Off-Formulary Interchangeability