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Author

Stuart Walker

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Open access Sep 2026

Operationalization of the African Medicines Agency: Retrospective evaluation of the continental centralized pilot procedure timelines to recommendation and national registrations.

AIMS Regulatory inconsistency across Africa causes duplicative assessments, prolonged approvals, and delayed medical access. To inform the African Medicines Agency (AMA), the African Medicines Regulatory Harmonisation (AMRH) piloted Africa's first continental scientific evaluation of human medicinal products. This stud...

Alex Juma Ismail, L. Moeti, D. Darko et al. · 0 citations
Review Open access Aug 2026

An evaluation of the use of the Universal Benefit-Risk Assessment Framework by the Zambia Medicines Regulatory Authority for documenting and communicating benefit-risk decisions.

This study evaluated the feasibility, usability and perceived value of applying UMBRA within the Zambia Medicines Regulatory Authority (ZAMRA) and compared the explicitness and structure of UMBRA benefit-risk documentation with the existing narrative approach.

Constance Sakala Chisha, Stephanie Leigh, Prudence Musonda Mubanga et al. · 0 citations

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