Publications
CIRS publishes insights from its research and meetings in several forms:
- R&D Briefings – research papers produced by the CIRS team e.g. annual regulatory and HTA benchmarking briefings
- Journal articles – peer reviewed academic research papers
- Reports – from CIRS workshops and externally commissioned research projects, as well as CIRS Annual Reports
- Books – research theses from CIRS-supported PhD students
- Posters – presented at external conferences
Keep up-to-date with CIRS publications and activities by signing up to our mailing list or following CIRS on LinkedIn.
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). The …
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 the …
CIRS RD Briefing 103 – Review of HTA outcomes and timelines in Australia, Canada, Europe and the UK, 2020-2024
This R&D Briefing presents findings from HTADock, an ongoing CIRS metrics study that collects publicly available data on new active substances (NASs) appraised by 12 HTA agencies in Australia (PBAC), …
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 Growth …
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 of …
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, with …
Enhancing Development Strategies Through Early HTA Scientific Advice – Wang 2025
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’ evidentiary …
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 substances …
CIRS 2024 Annual Report
Explore how the Centre for Innovation in Regulatory Science (CIRS) is shaping the future of regulatory and health technology assessment (HTA) policy worldwide. We’re delighted to present our latest Annual …
CIRS RD Briefing 99 – First HTA outcomes and timelines for oncology medicines approved by EMA 2018-2023
This R&D Briefing presents data from HTADock, an ongoing CIRS benchmarking study that collects publicly available data on new active substances (NASs) appraised by key international HTA agencies. This CIRS R&D …
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 European …
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 country. …