Snapshot

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

This pathway can be used where Designation is a formal process that allows TMDA to make a decision under the Tanzania and Medical Devices (Orphan Medicines) Regulations, 2018 regarding whether the medicine is eligible for orphan designation. The designation application precedes the registration application and is the formal application made using a specified form provided in first schedule of the Orphan Medicines, Regulations requesting assessment against the relevant eligibility criteria and a decision from TMDA. Application and evaluation fees are waived for prescription medicine registration applications if a related orphan designation is in force. You can lodge an application for registration of an orphan medicine through any available prescription medicine authorization process, subject to meeting the requirements for that authorization process. Eligibility criteria for the orphan medicines program are: (1) The medicines are intended for use in a life- threatening or chronically debilitating condition affecting not more than 25,000 persons in Tanzania at the time of designation and or application of marketing authorization; (2) The medicines are intended for use in a life-threatening, seriously debilitating or serious and chronic condition in Tanzania and that without incentives it is unlikely that the marketing of the medicinal product in the country would generate sufficient return to justify the necessary investment and; (3) There exists no satisfactory method of diagnosis, prevention or treatment of the condition in question that has been registered in Tanzania or, if such method exists, that the medicinal product will be of significant benefit to those affected by that condition..

This pathway accelerates the regulatory review process.

It is an abridged review (a reliance pathway).

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.