Snapshot

The Priority Review pathway has been developed by the Rwanda Food and Drugs Authority (RFDA) of Rwanda.

This pathway can be used where All products on condition that the product is intended for treatment of a serious or life-threatening disease. .

This pathway accelerates the regulatory review process.

It is an abridged review (a reliance pathway).

When relevant, the agency relies on prior decisions from Australia Brazil Canada China EU-EMA East African Community (EAC) Japan Mexico Saudi Arabia Singapore South Korea Switzerland Taiwan (Chinese Taipei) Tanzania Turkey United Kingdom United States WHO

Rwanda FDA shall complete screening of the dossier for completeness within 30 working days from receiving such application. In the event that the dossier is incomplete, it will be rejected. The applicant will be notified of the rejection. In case of a positive outcome during screening, Rwanda FDA shall notify the marketing authorization holder (MAH) in writing that the screening has been successfully completed and place the dossier in the evaluation queue. Review of application for marketing authorization of a product will follow the appropriate evaluation queue. Priority review may be granted where the product is intended for treatment of a serious or life-threatening disease. Evaluation of priority products is carried out within 6 months from receiving the application.