Incentivising Medicine Development for Chronic Diseases – Workshop Synopsis
This CIRS multi-stakeholder workshop examined strategies for incentivising the development of medicines for common chronic diseases.
How are international regulatory organisations shaping global pharmaceutical policy? Dangy-Caye et al 2025
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 [...]
Evaluation of good review practices at FDA Ghana – Owusu-Asante 2025
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 [...]
CIRS RD Briefing 102 – Tracking Availability in China of Medicines Approved in Six Key Global Markets
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, [...]
Regulatory Collaboration and System Strengthening – Workshop Report
This CIRS multi-stakeholder workshop examined success factors for strengthening regulatory systems to support the implementation of collaborative models.
Assessing the Malaysian Regulatory Process with OpERA Methodology – Mohd Sani 2025
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 [...]
CIRS RD Briefing 101 – New drug approvals by six major authorities 2015-2024
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 [...]
Comparison of review models and timelines in ECOWAS – Owusu-Asante 2025
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 [...]
Structured benefit risk assessment: South African regulator case study – Danks 2025
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 [...]
Testing the UMBRA benefit-risk tool in a South African agency
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 [...]