Abstract
BackgroundMedicines regulatory harmonization has been recommended as one way to improve access to quality-assured medicines in low- and middle-income countries. The rationale is that by lowering barriers to entry more manufacturers will be enticed to enter the market, while the capacity at the national medicines regulatory authorities is strengthened. The African Medicines Regulatory Harmonization Initiative, agreed in 2009, is developing regional platforms with harmonized regulatory procedures for the registration of medicines. The first region to implement medicines regulatory harmonization was the East African Community (EAC). The harmonization was based on the existing EAC Free Trade Agreement, which officially launched the free movement of goods and services in 2010.Methods and findingsIn this study we conducted semi-structured interviews and performed document reviews. The main target group for our interviews was pharmaceutical companies. We interviewed 18 companies, including 64% of the total companies who had experienced the EAC joint product assessment procedure, and two EAC-based national medicines regulatory authorities. We found that generally pharmaceutical companies are supportive of the African-based MRH efforts and appreciative of the progress being achieved. However, many companies are now hesitant to use the joint product assessment procedure until efficiency improvements are made. Common frustrations were the length of time to receive the actual marketing authorization; unexpectedly higher quality standards than national procedures; and challenges in getting all EAC countries to recognize EAC approvals. Smaller, less attractive markets have not yet become more attractive from a corporate perspective, and there is no free trade of pharmaceuticals in the EAC region.ConclusionsPharmaceutical companies agree that medicines regulatory harmonization is the way forward. However, regulatory medicines harmonization must actually result in quicker access to the harmonized markets for quality-assured medicines. At this time, improvements are required to the current EAC processes to meet the vision of harmonization.
Highlights
Insufficient access to essential medicines remains one of the biggest public health challenges in Africa [1]
We interviewed 18 companies, including 64% of the total companies who had experienced the East African Community (EAC) joint product assessment procedure, and two EAC-based national medicines regulatory authorities
We found that generally pharmaceutical companies are supportive of the Africanbased MRH efforts and appreciative of the progress being achieved
Summary
Insufficient access to essential medicines remains one of the biggest public health challenges in Africa [1]. In 2017 almost three million children under the age of five died in Sub-Saharan Africa, more than any other geographic region [2] Many of these deaths could have been prevented by access to stronger healthcare systems capable of ensuring access to quality-assured medicines and other services. A weakly functioning NMRA can result in delayed assessment of marketing authorization applications, which may promote the introduction of counterfeit medicines [5]. This applies to new medicines representing advances in treatment, and generic medicines. The harmonization was based on the existing EAC Free Trade Agreement, which officially launched the free movement of goods and services in 2010.
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