Janssen Pilot Speeds Up African Approvals As Harmonization Project Expands

Executive Summary

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.