Snapshot

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

This pathway can be used where Biological products such as vaccines, blood and blood components, allergenics, somatic cells, cellular and gene therapy products, tissues, and recombinant therapeutic proteins. .

This pathway accelerates the regulatory review process.

It is an abridged review (a reliance pathway).

After receiving the product application, Rwanda FDA shall proceed with screening of the dossier for completeness. In the event that the dossier is incomplete, it will not be scheduled for assessment and the applicant will be notified within 30 working days and requested to comply with requirements in writing. In case of a positive outcome during the screening, the application will be scheduled for assessment according to the First in First Out (FIFO) rules. Priority assessment may be granted where the product is intended for treatment of rare disease conditions through an expression of interest (EOI DHT/FMT/032) or in the case of an emergency situation. New applications are processed within nine (9) months of receipt of application; no exact timelines stated for priority assessment. Additional data or query responses are processed within sixty (60) calendar days.