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.
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- Ontario Guidelines for Drug Submission and Evaluation
- Drug Submission Status
- Improving Patient Access to Drugs: Rapid Review Process
- Single Monthly Formulary Process
- Off-Formulary Interchangeability
- Ontario Guidelines for Economic Analysis of Pharmaceutical Products
- Submission Guidelines for Oncology Drugs
- Inter-Provincial Joint Oncology Drug Review Process
- Submission Guidelines for Diabetic Testing Agents
- Submission Guidelines for Nutrition Products
- New Submission Deadline Dates for Multiple Source Products
- Guideline and Template Downloads