Viability of Medicines Regulatory Harmonization (MRH) Regional Programs in advancing medicines Access – Case of New Drug Applications for East Africa Community (EAC) MRH

Abstract

Abstract Access to essential medicines remains a significant challenge for patients in Africa. This is attributable to, among other factors, overreliance on imports from other countries for essential medicines, poor healthcare infrastructure, and weak regulatory systems. This is more apparent in the case of communicable diseases of Malaria, HIV, and TB in addition to the rising non-communicable diseases burden whose medicines access has been affected by the inefficient regulatory systems. Realizing this need, African countries through the support of WHO and the donor community started initiatives to strengthen regulatory systems over the last decade with the view to bring Africa towards being at par with other countries and regions of the world. An example has been the 2009 Africa Medicines Regulatory Harmonization (AMRH) program started with the goal of harmonizing regulatory requirements across Africa through regional economic communities as interim building blocks. In East Africa, such an initiative was launched in 2012 resulting in multiple regulatory milestones being fulfilled to date. Past studies have assessed the utility of the process from a regulator’s perspective. The current study assessed the impact of EAC MRH from an industry perspective as a tool to accelerate medicines access. The study looked at retrospective data covering fifteen years in the company regulatory database showing approval timelines for new drug applications using the traditional/national procedures in comparison to the EAC MRH procedure. From the results, there was a reported reduction in regulatory timelines for new drug application authorizations among the member countries from a high of up to 17 months to 12 months on average. Additionally, the EAC MRH process was found to be predictable, transparent, and a platform to practice regulatory reliance, therefore, facilitating quicker access to health products and medicines for patients. From the findings, applicants are encouraged to explore the EAC MRH route as an alternative to the national regulatory procedures as one way to guarantee faster access to health products and medicines. It is also recommended to address the gaps in the national procedures that have been shown to delay regulatory decisions in the East Africa region. This report however did not cover other regulatory aspects such as the sustainability of the program, post-approval changes, GMP inspection, and vigilance which are not as well developed and which should be a focus for future work by industry and regulators.