Transparent and consistent benefit-risk assessment is fundamental to regulatory decision making and stakeholder confidence in medicines regulation. This study evaluated the application of the Universal Methodology for Benefit-Risk Assessment (UMBRA) [...]
Good Review Practices (GRevPs) are an important component of regulatory systems strengthening and support progress in World Health Organization (WHO) Global Benchmarking Tool (GBT) assessment. This poster was presented [...]
This poster was presented at DIA 2026 and examines the development of the African Medicines Agency (AMA), tracing its evolution from the African Medicines Regulatory Harmonisation (AMRH) Programme to its [...]
This peer-reviewed publication, co-authored by researchers from the Zambia Medicines Regulatory Authority (ZAMRA), CIRS, and the University of the Witwatersrand, evaluates the quality of decision making practices used by [...]
Introduction: The implementation of Good Review Practices (GRevPs) ensures the timely, high-quality review and enhanced availability to safe, quality, and efficacious medicines. It is important, therefore, that all aspects of [...]
Background The World Health Organization (WHO) developed the WHO Global Benchmarking Tool (GBT) to assess and benchmark the drug regulatory systems and practices in national medicines regulatory authorities (NMRAs). [...]
The aim of this study was to assess the good review practices (GRevPs) of the Food and Drugs Authority (FDA) Ghana in order to identify opportunities for improvement. Reviewers [...]
Background: The Malaysian National Pharmaceutical Regulatory Agency (NPRA) has partnered with the Centre for Innovation in Regulatory Science (CIRS) since 2018 to analyze the approval processes for new active [...]
Introduction National regulatory medicines authorities (NRAs) are mandated to ensure timely access to high-quality, safe and efficacious medical products, primarily achieved through a marketing authorisation procedure established in each [...]
This study investigates the utility of the Universal Methodology for Benefit-Risk Assessment (UMBRA) framework within the South African Health Products Regulatory Authority (SAHPRA) to determine whether adopting a structured [...]
