Authorization of Clinical Trials

Clinical Trial Application (CTA) shall be submitted to TMDA by filling application form. For more details on the regulations of clinical trials in Tanzania click here.

The applicants shall submit their CTA(s) as per the Modules and the Common Technical Document (CTD) highlighted in Guidelines for Application to Conduct Clinical Trial in Tanzania.

The CTA(s) shall be completed online through this link. In addition, the CTA documents shall be presented in both A4 papers spring file folders and in electronic format in Compact Discs (CDs).

Application for amendment(s) to a previously authorized clinical trial shall be made in forms whichever is applicable, and shall be accompanied with amendment fees as prescribed in the Fees and Charges Regulations.

Import and export of study products follows the normal TMDA requirements for Import and Export of regulated products. Click here.

For related guidelines on clinical trials oversight. Click here.