A pilot project of joint assessments in East Africa has shown that regulatory review times for a number of branded medicines were reduced from one or two years to a median of seven months, representing a reduction of 40-60%. The project was part of the African Medicines Regulatory Harmonization initiative, which is intended to strengthen and align regulatory practices in sub-Saharan Africa. Part one of this article looks at the history of the AMRH, the 2016 Model Law that guides national regulators in implementing their own procedures, and the East African pilot that has shown joint reviews to be feasible at the regional level.
The African Medicines Regulatory Harmonization (AMRH) initiative, a project aimed at strengthening and harmonizing drug regulatory systems in Africa, is being expanded after a trial of joint regional assessments and other collaborative review practices showed it was possible to secure timely drug approvals and avoid duplication of effort.
Under a joint assessment pilot carried out with a number of drugs in five East African countries in 2015-16 as...
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