Objectives Regulators must balance medicine benefits and risks while ensuring consistency, transparency, and efficiency in decision-making and the aim of this study was to assess UMBRA’s impact on SAHPRA [...]
Objectives To identify the current perspective of the FDA Ghana in the implementation of Good Review Practices, provide a baseline on the knowledge, attitudes, practices, as well as identify [...]
Objectives 1. To investigate ways in which the regional initiative could be well coordinated.2. To propose an improved model for the East African Medicine Regulatory Harmonisation Initiative joint assessments.3. [...]
Objectives To assess the quality of the decision-making process followed by regulatory reviewers, explore their perceptions of the Zambia Medicines Regulatory Authority (ZAMRA) decision-making approach, and evaluate the usefulness [...]
Background and Objectives The inherited backlog of 16,000 medicines applications of the South African Health Products Regulatory Authority (SAHPRA) was cleared through facilitated review pathways that included reliance on [...]
Background In 2012, the East African Community Medicines Regulatory Harmonization (EAC-MRH) initiative was established to improve access to safe, effective, and high-quality medical products to patients in the East [...]
Introduction: When implemented by national and regional regulatory agencies good review practices (GRevPs) support the timely high-quality review of medicines for enhanced patients’ availability to safe, quality and efficacious [...]
Purpose: This study aimed to assess the current regulatory review process of the Zambia Medicines Regulatory Authority (ZAMRA) by identifying the key milestones and target timelines achieved for products [...]
Introduction: Medicines regulatory harmonisation has been embraced by many national regulatory authorities (NRAs) to improve public health through faster availability of safe, high-quality, and effective medical products to patients [...]
Introduction: The East African Community Medicines Regulatory Harmonisation (EAC-MRH) programme was established to address challenges faced by national regulatory authorities (NRAs) of the region. Work sharing through joint assessments [...]
