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Article
Medicine, General & Internal
Regulatory Authority Evaluation of the Effectiveness and Efficiency of the ZaZiBoNa Collaborative Medicines Registration Initiative: The Way Forward
Tariro Sithole et al.
Summary: ZaZiBoNa, a work-sharing initiative in SADC, has assessed over 300 applications in 8 years with a median recommendation time of 12 months. While successful, challenges remain, including resource inadequacy and varying implementation times by countries. Establishing a regional unit for centralized submission and coordination is recommended to improve effectiveness and efficiency, with the long-term goal of a regional medicines authority.
FRONTIERS IN MEDICINE (2022)
Article
Pharmacology & Pharmacy
Evaluation of the Effectiveness and Efficiency of the East African Community Joint Assessment Procedure by Member Countries: The Way Forward
Nancy Ngum et al.
Summary: The EAC-MRH initiative has been valuable in achieving shorter approval timelines for medicines, promoting information sharing among regulators, and building capacity for assessments. However, challenges such as lack of central tracking system, inadequate human resources, and manufacturers' failure to submit the same dossier to all interested countries have hindered effectiveness and efficiency. A robust IT system and central payment point are key strategies needed for improvement.
FRONTIERS IN PHARMACOLOGY (2022)
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