Incentivising Medicine Development for Chronic Diseases – Workshop Report
This CIRS multi-stakeholder workshop examined strategies for incentivising the development of medicines for common chronic diseases.
Regulatory performance of ML3 African NMRAs – Owusu-Asante 2025
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). [...]
Contribution of the ECOWAS region to the African Medicines Agency
“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 [...]
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 [...]