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 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 [...]