Snapshot

The Expedited/Fast-Track Review Process pathway has been developed by the of Sierra Leone.

This pathway can be used where allopathic/medicinal products.

This pathway accelerates the regulatory review process.

It is an abridged review (a reliance pathway).

1. Processing of fast-track applications – applications under this category shall have a decision made within three (3) months. 2. Processing of locally manufactured applications- applications under this category shall have a decision made within three (3) months. 3. Processing of new applications (imported medicines) - A decision on a new application will be made within 6 months of receipt of the application. The applicant will be required to provide any requested additional data within 6 months. In case additional time is required, a formal request must be submitted to the PBSL. 4. Processing of WHO prequalified or SRA-approved products - The PBSL shall process the application and communicate its decision on the product to the applicant and WHO within 21 calendar days.