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African Regulatory Harmonization Project Cuts Drug Approval Times And Saves Scarce Resources

Executive Summary

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.

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