Evaluation of medicines regulatory interventions in the east African community region
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Date
2021
Authors
Ndomondo-Sigonda, Margareth
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Abstract
The study assessed the effect of the Medicines Regulatory Harmonization (MRH) initiative in
improving regulatory capacity in the East African Community (EAC) Partner States. An
exploratory mixed-method design using both qualitative and quantitative data, was employed.
Data was collected from six National Medicines Regulatory Authorities (NMRAs) and the EAC
Secretariat through a combination of semi-structured interviews, questionnaires, and
checklists for the period 2011/12-2014/15 while 2010/11 data served as baseline. Interviews
were conducted with heads of agencies; regulatory and monitoring and evaluation experts;
and the EAC Seretariat Project Officer. NMRAs performance was measured using a set of 29
indicators grouped into 9 categories. In addition, document review using published reports,
grey literature and media articles was conducted. Collaboration, harmonization, joint dossier
reviews and inspections of manufacturing sites; reliance and cooperation were identified as
key factors for building trust and capacity among NMRAs. Results show that 83.3% of the
EAC Partner States have comprehensive medicines laws with autonomous NMRAs. All the
NMRAs have functional registration and inspection systems for pharmaceutical manufacturing
sites. They all use regional harmonised guidelines for registration, inspection, quality
management and information management system. 80% of the NMRAs have attained
ISO:2015 certification. Efficiency of registration processes has improved by 66.6% Industry
concerns on joint review process; transparency; and accountability are areas to be addressed
by EAC NMRAs. Different financing models are used to regulate pharmaceutical markets in
the region with Burundi NMRA relying on government funding while others use a combination
of sources of revenue. Zanzibar NMRAs is financed through government (50.40%), industry
fees (40.60%) and donors/other sources (9%). For Tanzania-Mainland; the industry fees
contribution increased from 60% ($2,018,608.88) in 2011 to 86% ($8,123,093) in 2015 with
Government contributing on average 19.60% ($1,168,299.09) over the studied period. The
Ugandan NMRA depends 98.25% on industry fees ($8,077,238.20). The indicators generated
out of this research can be replicated for evaluation of similar initiatives across and beyond
the African continent and contribute to public health policy.
Description
A thesis submitted in fulfilment of the requirements for the degree of Doctor of Philosophy to the Faculty of Health Sciences, School of Therapeutic Sciences, University of the Witwatersrand, Johannesburg, 2021