Posted On: Dec 10, 2020
TANZANIA MEDICINES AND MEDICAL DEVICES AUTHORITY
CLARIFICATION ON FEES AND CHARGES FOR ACADEMIC RESEARCH
- Tanzania Medicines and Medical Devices Authority (TMDA) regulates amongst others the design and conduct of clinical trials for medicines, medical devices and diagnostics pursuant to the Tanzania Medicines and Medical Devices (Clinical Trials Control) Regulations, 2013.
- TMDA would like to clarify to researches, investigators and the general public that it does not regulate academic research conducted by students from Universities and Colleges.
- In this respect no fees or charges are accepted by TMDA as it does not receive such applications either.
- Students are required to apply and obtain Ethical Clearance from the National Institute for Medical Research (NIMR) only for their studies which intend to answer scientific questions from academic standpoint.
- Pursuant to section 5(1) of the Tanzania Medicines and Medical Devices (Clinical Trials Control) Regulations, 2013, TMDA issues clinical trial permits for the following categories of medicines:
- 5.1. Unregistered medicines
- 5.2. Registered medicines where the proposed clinical trails are outside the conditions of approval and may include changes to:
- indications and clinical use;
- target patient population(s);
- routes of administration; and
Tanzania Medicines and Medical Devices Authority (TMDA),
PSSSF Building, Block T, 10th Floor,
P. O. Box 1253, Dodoma
Phones: +255 22 2452108/2450512/2450751
Email Address: firstname.lastname@example.org