Evaluation of the implementation and the associated operating costs of a medicine regulatory harmonisation model in Africa: the case of ZaZiBoNa, a SADC work-sharing initiative.

ABSTRACT:

Background

To improve the access to and affordability of medicines, countries in the Southern African Development Community (SADC) established ZaZiBoNa, a medicine regulatory harmonisation initiative. Studies have evaluated the initiative's technical and operational efficiencies and effectiveness. This study evaluated ZaZiBoNa from project implementation and cost perspectives, at the 5-year mark, to establish a business case for further investment.

Methods

A quantitative and desk review were undertaken. Two surveys, one with 7 National Regulatory Authorities (NRAs) that participated in the initiative in the initial 5 years were conducted and the other with 40 pharmaceutical companies who submitted applications in the same period were recruited to share their perceived experi

SUBMITTER: Dube-Mwedzi S 

PROVIDER: S-EPMC12024501 | biostudies-literature | 2025

REPOSITORIES: biostudies-literature