Snapshot

The Orphan Medicines pathway has been developed by the Tanzania Medicines & Medical Devices Authority of Tanzania.

This pathway can be used where Orphan medicines .

This pathway accelerates the regulatory review process.

It is an abridged review (a reliance pathway).

Target time assessment is An Applicant may submit an application to TFDA at any stage of development of a medicinal product, during review of the application or after marketing authorization has been granted for a different indication to obtain the designation status. Review and approval of the request for designation of an orphan medicines = Within 30 days. Review of responses (if additional information requested) = Within 5 days. Notes to applicant on the outcome of the designation application = Within 7 days. Review and approval of marketing authorization of orphan medicines = Not more than 60 days (2 months) from the date of orphan designation..