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, [...]
Background: National regulatory authorities (NRAs) make the decision to register a medicine based on an assessment of its benefits and risks and publicly available assessment reports are used as [...]
The Southern African Development Community (SADC) collaborative medicines registration initiative ZaZiBoNa is a successful regional work-sharing initiative on the African continent. This paper reviews the history of the ZaZiBoNa [...]
Background This study sought to identify criteria and current practices for implementing an abridged review process and understanding barriers and enablers in utilizing reliance models and to offer recommendations [...]
Background: Timely access to new medicines may be addressed through strengthening of registration efciencies and timelines by establishing and refning value-added registration processes, resources, and systems. The aims of [...]
Introduction: Comparisons between regulatory authorities of similar size and regulatory characteristics facilitate value-added benchmarking and provide insight into regulatory performance. Such comparisons highlight areas for improvement as authorities move [...]
The emerging markets of Asia-Pacific, the Middle East, Africa and Latin America are becoming increasingly important to pharmaceutical companies in their global strategies for the registration of new medicines [...]
The regulatory agencies in the Middle East and African region that were included in this study share a common goal with the research-based pharmaceutical companies that they regulate. This [...]