New Deal To Boost Progress On African Medicines Agency
Increasing Local Drug Production Is Also On The Agenda
A new agreement between the WHO and the African Union is expected to strengthen efforts to create the new African Medicines Agency, following the endorsement of the AMA treaty earlier this year.
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African health ministers have agreed on a treaty to set up a new pan-African agency to coordinate regional drug regulatory harmonization initiatives and pool limited regulatory expertise.
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.
France is exploring the use of hydroxychloroquine and lopinavir/ritonavir in COVID-19, but only in hospitalized patients and in clinical trials, and has banned all exports of the products to avoid possible shortages.