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) [...]
Overview Health technology assessment (HTA) plays a key role in supporting evidence-informed healthcare decision making, pricing, reimbursement, and coverage decisions worldwide. As countries seek to strengthen health policy and [...]
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 [...]
As companies navigate diverse global HTA environments, new CIRS analysis provides timely evidence on the role of parallel regulatory/HTA submissions. Our latest publication in the International Journal of Technology [...]
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). [...]
We’re pleased to share our latest publication in Frontiers in Medicine, developed in collaboration with Sanofi, exploring how international regulatory organisations are shaping global pharmaceutical policy. Data from our [...]
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 [...]
Introduction Early health technology assessment (HTA) advice provides value to pharmaceutical companies during drug development by identifying potential data gaps, refining study designs, and improving understanding of HTA agencies’ [...]
