Drug Submissions

Improving Patient Access to Drugs: Rapid Review Process

The ministry has developed a rapid review process for truly innovative drugs. This means that the ministry's Committee to Evaluate Drugs could begin the funding review process in Ontario prior to the drug receiving federal approval for sale in Canada (i.e. receipt of Notice of Compliance [NOC]).

The ministry is setting a benchmark that funding recommendations would be made by the Committee to Evaluate Drugs within 30 days following the drug product's receipt of NOC or NOC/c.

The ministry's commitment to this process is evident. Regulations to the Ontario Drug Benefit Act include provisions that enable the rapid review to occur in section 12 of O. Reg. 201/96.

The Guidelines for Rapid Review Submissions [PDF] updated October 2007 contains the following information:

Submission Requirements
Pre-NOC Rapid Review Submissions
Post-NOC Rapid Review Submissions
Submission Process
Letter of Authorization to Collect and Disclose Pre-NOC Information
Pre-NOC Rapid Review Process Flow Chart

Pharmaceutical manufacturers should refer to this web site for any future updates to the Rapid Review Process.

To view PDF format files, you need to have Adobe Acrobat® Reader installed on your computer.
You can download this free software from the Adobe Web site.

See Also:

Ministry Status: Activation Status

Drug Submissions

Improving Patient Access to Drugs: Rapid Review Process

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