African regulators are taking bold transformative steps to optimise the effective and efficient use of their agency resources to assure access to quality, safe and effective medicines. In particular, the East African Community (EAC) has harmonised processes and technical requirements for medicines, marketing applications that are consistent across the region and aligned with international best practices, and establish an accelerated joint marketing authorisation pathway.

CIRS Head of Regulatory Collaborations, Dr Lawrence Liberti, was invited to provide an independent perspective alongside other regulatory experts on the work of the EAC Medicines Regulatory Harmonisation initiative and its plans for the future. This is the final article in a Special Collection in PLOS Medicine.