Dubbed ‘ASCEND-Moving Tanzania’s clinical research ethics and medicines regulatory capacity to the next level’, the two years and a half project will focus on strengthening systems and facilitate more clinical research.
Speaking during the project kick-off meeting held in Dar es Salaam over the weekend, TMDA Director General Adam Fimbo said the project is expected to strengthen pharmacovigilance systems to increase reports on adverse events and reactions originating from clinical trials and establishing an effective system for information sharing.
Pharmacovigilance, also known as drug safety, is the pharmacological science relating to the collection, detection, assessment, monitoring, and prevention of adverse effects with pharmaceutical products.
He said the project also secured funds worth Euro 498,750 (1.4bn/-) from the European Development Countries Clinical Trials Partnership (EDCTP) whereby the process of funding acquisition began in October 2019, the acquisition process engaged Seven institutions.
He cited the seven institutions as Kilimanjaro Clinical Research Institute (KCRI), Muhimbili University of Health and Allied Sciences (MUHAS), National Institute for Medical Research (NIMR), Zanzibar Food and Drugs Authority (ZFDA), Zanzibar Health Research Institute (ZAHRI), University of St Andrews (UStAN) and TMDA.
According to Fimbo, through the project the systems for up scaling clinical research ethics and medicines regulatory capacity to monitor and regulate medical researches and trials in the country will be improving.
The DG further said that TMDA has also approved 197 clinical trials conducted in the country since 2008 so as to ensure they comply with national and international laws, regulations, guidelines, and standards.
According to him, the approved clinical trials were out of the 213 received; among them, five were rejected, three were terminated, and five were queried waiting for the response while three are under assessment.
Chief Medical Officer- Ministry of Health, Community Development, Gender, Elderly, and Children Dr Abel Makubi said before being appointed for the post while working at the Mwanza-based Bugando Medical Center he used to engage in various research activities including conducting clinical trials.
“I experienced mounting challenges to include delays in the authorization of clinical trials due to delays in ethical and regulatory reviews. These critically slow down efforts put forward by investigators and frustrate sponsors of research,” Makubi said.
Makubi said the ministry has formulated National Health Policy and monitors its implementation, providing for setting up of systems for conducting research in the country, effective regulatory control, and ethical reviews.
The CMO said the policy further compels regulators and ethics committees to ensure that research including clinical trials is designed and conducted to protect participants from any potential harm.
He urged academic institutions to train and produce professionals with the necessary knowledge and skills in managing patients including being engaged in research that observes good research practices.
Dr Ndekya Oriyo, NIMR’s Director of Research Information, Technology and Communication said the ASCEND project enables the institute in collaboration with TMDA to focus on issuing permits to researchers who do studies on vaccines, treatment, and medical devices.
“We have a database of all findings for health research conducted across the country. Our duties include sending reports on the findings to the Ministry of Health as well as advising it on the proper policy and health plans for clinical trials,” Oriyo said.
Earlier, TMDA manager for clinical trials and pharmacovigilance Kissa Mwamwitwa said that the authority will continue creating a better environment for conducting clinical trials by improving time for the approval processes, and consequently, the overall oversight of clinical trials will be improved.
“The implementation of the ASCEND project with strong collaboration of all consortium members and stakeholders will strengthen systems on conduct of clinical trials research, ethics, and pharmacovigilance in the country,” she added.
Mwamwitwa said the project will help to improve the efficiency and quality of the work of the national research ethics and regulatory agency for clinical trial reviews and pharmacovigilance.