ISO 9001: 2015: CERTIFIED

PUBLIC NOTICE

01^st June, 2023

Publication of Clinical Trial Public Assessment Reports and GCP Public Inspection Reports

1. Tanzania Medicines and Medical Devices Authority (TMDA) wishes to inform Clinical trial Investigators and Sponsors that in the effort to promote transparency of clinical trial oversight in the country, the Authority is obliged to publish Clinical trial public assessment reports (CTPAR) and Clinical trial public inspection reports (CTPIR) of all approved and ongoing clinical trials on annual basis.
2. In light of this requirement, with effect from the 1st of June 2023, TMDA will officially start to publish CPAR and CTPIR on our website (www.tmda.go.tz) to inform the general public of the ongoing clinical trials in Tanzania.
3. Nevertheless, the publication will only be undertaken after obtaining the consent of the respective Principal Investigators and Sponsors. In view of this, the Principal Investigators and Sponsors will be required to provide their consent within 14 days from the date of the letter from TMDA.
4. Failure to respond to the Authority notice on this matter shall be assumed that respective Principal Investigators and Sponsors have consented and the Authority will proceed with the publication of the CTPAR and CTPIR.
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.