Clinical Trials Control
Regulatory overview of Clinical trial in Tanzania
Clinical trials in Tanzania are regulated and overseen by the Tanzania Medicines and Medical Devices Authority (TMDA), the National Health Research and Ethics Committee (NatHREC), and, if the investigator is a foreign person, by the Tanzania Commission for Science and Technology (COSTECH).
TMDA is responsible for clinical trial authorization, oversight, and inspections. The TMDA grants clearance for clinical trials to be undertaken in the country in compliance with the Tanzania Medicines and Medical Devices Act, 2003 Cap 219, Part IV, and the Tanzania Medicines and Medical Devices Regulations (Clinical Trials Control), 2013
The Tanzania Medicines and Medical Devices Authority (TMDA) requires the sponsor, his/her designated contract research organisation (CRO), or the investigator to obtain TMDA approval, according to the Guidelines for Application for Conducting Clinical Trials in Tanzania, the TMDA Act, and the Clinical Trial Regulations. The Tanzania Medicines and Medical Devices Regulation (Clinical Trials Control), 2013 under Regulations 4(l) requires the principal investigator (PI) to apply for the ethical clearance to the National Health Research Ethics Committee (NatHREC). The TMDA and NatHREC reviews may be conducted concurrently. The TMDA application, on the other hand, must include a copy of the national EC's acknowledgement of receipt for the study protocol. Furthermore, the TMDA's clearance will not be granted until the ethical clearance is obtained.
Clinical Trial Submission
Applicants who wish to conduct the clinical trial in Tanzania are required to submit clinical trial application online via the Regulatory Information Management System (RIMS) Customer Self Service Portal. Applicants must fill out CTAs as per the Modules and the Common Technical Document (CTD) highlighted in the Guidelines for application for conducting clinical trial in Tanzania. Applications for amendment(s) to a previously authorized clinical trial must be submitted on the applicable form in RIMS. The clinical trial application form is available at (www.tmda.go.tz), and the application forms for protocol amendments are at (www.tmda.go.tz). Note that a list of clinical trial forms is posted to (www.tmda.go.tz)
In addition, the TMDA Regulatory Information Management System (RIMS) Customer Self Service Portal provides applicants with various online regulatory services. Annex 1 of the Guidelines of Application for Conducting Clinical Trials provides the Clinical Trial Application Form template. Applicants should submit their applications as per the Modules in the Guidelines for Application for Conducting Clinical Trial and the Common Technical Document (CTD) highlighted in the same Guidelines. The overall organization of the CTD format should not be modified.
As per mentioned Guidelines, all applications and supporting documents must be in English. The informed consent documents must be in both Kiswahili and English
Clinical Trial Review Process
According to the Guidelines for Application for Conducting Clinical Trials in Tanzania, the TMDA review process is conducted on a first-in, first out basis. TMDA will evaluate complete applications within 60 working days of receiving the application. The fast-track evaluation provides that a new clinical trial application may be fast tracked and assessed within 30 working days of its submission if the applicant has requested and paid twice the prescribed clinical trial application fee.
As stipulated in the Guidelines for Application for Conducting Clinical Trials in Tanzania, the TMDA Act, and the Clinical Trial Regulations, the Authority process the clinical trial applications once receipt of a clinical trial application, the TMDA initially screens the application for completeness, if complete, the Authority continue with the review process. The TMDA may request a clarification or additional documents through the online submission system known as RMIS for incomplete application of the clinical trial. The assessment will resume once the applicant has provided clarification and responded the queries through the RMIS.
The authority will review the application according to the existing Guidelines and SOPs if there is deficient or additional information about the application a query is raised and communicated to the applicant, the evaluation process is stopped until the TMDA receives a written response. The response should be provided within six (6) months of receiving the query letter. Furthermore, TMDA reserves the authority to require information or impose conditions not clearly stated in the Guidelines for Application for conducting clinical trials in Tanzania in order to adequately assess an investigational product's safety, effectiveness, or quality (IP)
Fees and Charges
As per the Guidelines for conducting clinical trials in Tanzania and the Tanzania Medicines and Medical Devices (Fees and Charges) Regulations , applicants are required to pay a processing fee for conducting clinical trial in Tanzania. The TMDA Fees and Charge Regulations indicates that the Tanzania Medicines and Medical Devices Authority (TMDA) levies the following processing fees
- $3,000 USD for submitting a clinical trial application
- $6000 USD for fast-track clinical trial applications
- $500 USD for amendments for major changes in clinical trials
- $300 USD for amendments for minor changes in clinical trials
See the Tanzania Medicines and Medical Devices (Fees and Charges) Regulations) for a complete list of TMDA fees and charges.
The Guidelines for Application for Conducting Clinical Trials in Tanzania stipulate that the fee must be paid to the TMDA directly to the bank by draft electronic transfer through the following accounts:
The Banks accounts are linked to Government electronic payment gateway (GePG ) payments as follows:
- NAME: GEPG TMDA COLLECTION ACCOUNT (USD), BANK: NMB REVENUE BANK, ACCOUNT NO: 20810015291, BRANCH: UNIVERSITY
- NAME: GEPG TMDA COLLECTION ACCOUNT (USD), BANK: NBC USD, ACCOUNT NO: 040105002468, BRANCH: UDSM
- NAME: GEPG TMDA COLLECTION ACCOUNT (USD), BANK: CRDB BANK US, ACCOUNT NO: 0250021399100, BRANCH: HOLLAND HOUSE
Applicants are responsible for all bank charges when payment is made by bank transfer.