“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 [...]
This CIRS multi-stakeholder workshop examined strategies for incentivising the development of medicines for common chronic diseases.
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 [...]
All approved medicines have been rigorously assessed by regulatory authorities to ensure their benefits outweigh the risks. Today, pharmaceutical companies are increasingly focused on integrated global drug development strategies, [...]
This CIRS multi-stakeholder workshop examined success factors for strengthening regulatory systems to support the implementation of collaborative models.
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 [...]
This R&D Briefing presents the results from the Centre for Innovation in Regulatory Science (CIRS) annual analysis of new active substance (NAS) approvals by six major regulatory agencies: the [...]
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 [...]
