Clinical trials in Tanzania are regulated and overseen by the Tanzania Medicines and Medical Devices Authority (TMDA), an executive agency under the Ministry of Health, Community Development, Gender, Elderly and Children (“Ministry of Health”).
Section 61 of the Medicine and Medical Devices Act Chapter 219, Revised Edition of 2019 of the laws of Tanzania (as amended from time to time) (the “Act”) defines clinical trials as:-
an investigation or series of investigations consisting of a particular description by, or under the direction of a medical practitioner, dentist or veterinary surgeon to the patient or animal where there is evidence that drugs, medical devices, or herbal drugs of that description has effects which may be beneficial to and safe to the patient or animal in question and the administration of the drugs, medical devices or herbal drugs is for the purpose of ascertaining beneficial and harmful effects.
Section 62 of the Act designates the TMDA with the responsibility of approving, supervising, and inspecting clinical trials within Tanzania, which includes granting permission for such trials to take place in the country. The TMDA fulfils this role by enforcing the Clinical Trials Regulations (Government Notice Number53 of 2013) (the “Clinical Trials Regulations”).
These regulations outline the application procedures for clinical trials, as well as the required standards for good clinical practices and the appropriate conduct during such trials.
Registration and processing of Clinical Trial applications: -
There are four parties involved in conducting clinical trials in Tanzania, namely: -
An application to conduct a clinical trial is made to TMDA by either the Sponsor or the Sponsor’s agent who shall submit a power of attorney attesting that he is a duly appointed agent. The appointed agent is required to also submit the following information:- a duly filled signed and stamped clinical trial application form accompanied by a covering letter addressed to the Director General of TMDA; general investigational plan; capacity building plans including training and updating of staff involved in the trial; current version of the study protocol signed and dated by Sponsor and the Principal Investigator; Principal Investigator’s brochure or prescribing information data sheet to conduct clinical trials; informed consent information or forms to conduct clinical trials by the participants of the clinical trial; declaration by Principal Investigator; declaration by the Monitor of the clinical trial; financial declaration by the Sponsor and the Principal Investigator; certified copy of insurance of study participants; ethical clearance certificate, or a copy of acknowledgement of submission of study protocol, from any approved institute for medical research; investigational medicinal product dossier and application fees.
Regulation 7 of the Clinical Trials Regulations further requires applicants for clinical trials to register their clinical trials in the National Registry with the trial registration number availed by TMDA.
Ethics Clearance approval
Obtaining approval for a clinical trial application from the TMDA in Tanzania is contingent on acquiring Ethics Clearance approval from the National Health Research Ethics Committee (NatHREC), which assesses the ethical implications of proposed research proposals for the clinical trial. Therefore, before applying for a clinical trial at the TMDA, the applicant must first obtain ethics approval from NatHREC for their proposed clinical trial and include a copy of the national Ethics Clearance acknowledgement of receipt for the study protocol from NatHREC in their application. Upon receipt of a clinical trial application, the TMDA initially screens the application for completeness. If complete, the Director General shall issue a Clinical Trial Certificate to authorize the trial to be conducted. The clinical trial certification will be valid up to the proposed duration of the study indicated in the application however, its validity will not extend beyond five (5) years, therefore if the clinical trial is projected to last more than five (5) years, the applicant must request an extension of the duration of the clinical trial.
Furthermore, TMDA must approve all amendments to a previously authorized protocol for changes that affect participant selection and monitoring; changes that affect clinical efficacy and safety requirements; changes that affect participant discontinuation; addition/deletion of an investigational site(s); changes that result in the extension of the duration of a trial; and/or changes that relate to the chemistry and manufacturing information that may affect drug safety and quality. In this regard, an application for amendment(s) of the clinical trial must be accompanied by clearance or authorization from NatHREC.
Progress reports
The Sponsor and the Principal Investigator are required to submit progress reports to TMDA on a 6 months basis from the date of initiation of the clinical trial, contrary to which shall cause the clinical trial to be terminated by the Director General.
Closing reports
After the clinical trial has been conducted and closed, the Sponsor and/or Principal Investigator are required to submit a closing report within 60 days. This is followed by a final study report within 6 months after the clinical trial closure unless otherwise justified. Additionally, the Sponsor or Principal Investigator must publish the results of a clinical trial after completion in any peer reviewed journals, books or any other materials to allow for a wider community including study participants, to access the data/evidence generated from the trial, and a copy of the publication must be submitted to TMDA for review.
Diana Bahesha - Advocate
Note: This is not a legal opinion and the contents hereof are not meant to be relied upon by any recipient unless our written consent is sought and explicitly obtained in writing.
