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 [...]
This journal article co-authored by CIRS, AUDA‑NEPAD, the African Medicines Agency (AMA), and University of Hertfordshire, reviews the development of the African Medicines Agency (AMA), tracing its evolution from [...]
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). [...]
“This book is a must-read for all those with interest in medicines regulation in Africa… It provides timely expert information for consideration and possible adoption during the operationalisation of [...]
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 [...]
This CIRS multi-stakeholder workshop examined success factors for strengthening regulatory systems to support the implementation of collaborative models.
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 [...]
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 [...]
