ISO 9001: 2015: CERTIFIED

PUBLIC NOTICE

23^rd January, 2023

REMINDER TO ALL SPONSORS AND PRINCIPAL INVESTIGATORS TO REGISTER AND UPDATE CLINICAL TRIAL INFORMATION ON THE NATIONAL CLINICAL TRIAL REGISTRY

1. The Tanzania Medicines and Medical Devices Authority (TMDA) would like to remind all Principal Investigators (PIs) and Sponsors whose trials have been authorized to be conducted in Tanzania to ensure that their trials are registered in the National Registry established by the Authority not later than twenty-one (21) days following the enrolment of the first study participant. Those that have already registered, whenever necessary, are required to provide an update on the status of the trial until its completion.
2. This directive is in line with the requirements prescribed in part III of Regulation 7 of the Tanzania Medicines and Medical Devices Clinical Trials Regulation of 2013. (Clinical Trials Control) and is among the conditions stated in the approval letter issued by the Authority in accordance with the Tanzania Medicines and Medical Devices Act, Cap. 219.
3. The National Registry for Clinical Trials can be accessed online through a link https://imis2.tmda.go.tz/portal/#/public/clinical-trial. In case of any challenges in the implementation of this directive, please contact any of the following officials: Mr. Fabian Lwanole (mobile No.: +255762533530, email: fabian.lwanole@tmda.go.tz; Mr. Saleh Mwenyevyale Mobile No.: +255753747474, email: salehe.mwenyevyale@tmda.go.tz; Mr. Sadam Kyamani (Mobile No.: +255783992449, email: sadam.kyamani@tmda.go.tz; and Mr. Keneth Mvili Mobile No.: +255762833901, email: keneth.mvili@tmda.go.tz.
4. We thank you for your continued cooperation.