Janssen Pilot Speeds Up African Approvals As Harmonization Project Expands
A recent pilot involving Janssen Pharmaceutica has shown that drug approval times were reduced from a median of 20 months to seven months in a set of sub-Saharan African countries using a new “collaborative registration procedure” as part of the African Medicines Regulatory Harmonization initiative. In part 2 of this article on the AMRH, we look at the results of the pilot, how the initiative is being expanded to include more countries and to cover clinical trials and pharmacovigilance, and how far efforts to set up an African Medicines Agency by 2018 might bear fruit.
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A meeting between the European Medicines Agency and representatives of the East African Community discussed whether the European agency could act as a model for a regulator in the six-country region.
Drug companies will be expected to play a key role in a proposed drug registration procedure under which resource-strapped regulatory bodies could get products to patients faster by relying on the approvals of “internationally respected” agencies.
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.