HTA Submission Trends for EMA-Approved Oncology Medicines 2018-2023
How quickly do oncology medicines move from EMA approval to HTA submission across Europe — and how might this change under the EU HTA Regulation? At ISPOR Europe 2025, [...]
Assessing Good Review Practices in Zambia Medicines Regulatory Authority – Chisha 2025
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 [...]
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.