THE UNITED REPUBLIC OF TANZANIA MINISTRY OF HEALTH TANZANIA MEDICINES AND MEDICAL DEVICES AUTHORITY

ISO 9001: 2015: CERTIFIED

PUBLIC NOTICE

08^th May, 2023

Timelines for Issuance of Clinical Trial Certificates

1. Tanzania Medicines and Medical Devices Authority (TMDA) wishes to inform Clinical trial Investigators and Sponsors that, we have noted conflicting timelines for the issuance of Clinical Trial Certificates between the Client Service Charter,4th Edition and the Guidelines for Application to Conduct Clinical Trials in Tanzania, March 2020 Edition.
2. Client Service Charter has defined 14 and 45 working days for emergency and normal applications, respectively while the Guidelines indicate 30 and 60 working days which are in line with the technical committee meeting schedules.
3. In view of this, we wish to inform all Investigators, and Sponsors that with effect from 1st June 2023, the Authority will be implementing the timelines prescribed by the Guidelines for Application to Conduct Clinical Trials in Tanzania.
4. We, therefore, request our esteemed customer to take note of these changes which will be enforced until when the existing Client Service Charter is reviewed.
5. For further clarification on this notice, please do not hesitate to contact the Authority through e-mails: clinicaltrials@tmda.go.tz or info@tmda.go.tz. You may also send a letter via the address listed below, not later than 14 days from the date of this notice.
6. We thank you for your continued cooperation.

Issued by:
Director General,
Tanzania Medicines and Medical Devices Authority (TMDA),
Hombolo Road,
P. O. Box 1253, Dodoma