Sound regulatory systems are critical for protecting public health against use of medical products which do not meet international standards of quality, safety and efficacy. This review provides a summary of the current status of National Medicines Regulatory Authorities (NMRAs) in Africa, and various initiatives that have been established to improve their performance. All countries in Africa (except Sahrawi Republic), have NMRAs but their organizational set-up and functionality is variable. Some are located within Ministries of Health and others are semi-autonomous. There is progressive improvement in regulatory capacity, particularly in quality control and post-marketing surveillance, pharmacovigilance and clinical trials oversight. The African Vaccines Regulatory Forum, African Medicines Regulatory Harmonization Initiative, Network of Official Medicines Control Laboratories and WHO Prequalification Scheme have helped countries strengthen their regulatory capacities. The potential establishment of the African Medicines Agency (AMA) in 2018 is an opportunity to improve NMRAs’ capacity in Africa.
BackgroundInsufficient access to essential medicines is a major health challenge in developing countries. Despite the importance of Standard Treatment Guidelines and National Essential Medicine Lists in facilitating access to medicines, little is known about how they are updated. This study aims to describe the process of updating the Standard Treatment Guidelines and National Essential Medicine List in Tanzania and further examines the criteria and the underlying evidence used in decision-making.MethodsThis is a qualitative study in which data were collected by in-depth interviews and document reviews. Interviews were conducted with 18 key informants who were involved in updating the Standard Treatment Guidelines and National Essential Medicine List. We used a thematic content approach to analyse the data.FindingsThe Standard Treatment Guidelines and National Essential Medicine List was updated by committees of experts who were recruited mostly from referral hospitals and the Ministry of Health and Social Welfare. Efficacy, safety, availability and affordability were the most frequently utilised criteria in decision-making, although these were largely based on experience rather than evidence. In addition, recommendations from international guidelines and medicine promotions also influenced decision-making. Cost-effectiveness, despite being an important criterion for formulary decisions, was not utilised.ConclusionsRecent decisions about the selection of essential medicines in Tanzania were made by committees of experts who largely used experience and discretionary judgement, leaving evidence with only a limited role in decision-making process. There may be several reasons for the current limited use of evidence in decision-making, but one hypothesis that remains to be explored is whether training experts in evidence-based decision-making would lead to a better and more explicit use of evidence.
• Independent, science-based regulation of medical products is a critical part of ensuring quality healthcare. When conducted in a transparent, science-based, efficient, accountable, and predictable manner, it can help ensure access to quality products that patients need.
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