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.
CIRS RD Briefing 106 – New drug approvals by six major authorities 2016-2025
Overview This R&D Briefing presents the Centre for Innovation in Regulatory Science (CIRS) annual analysis of new active substance (NAS) approvals by six major regulatory authorities: the European Medicines Agency …
Navigating national decision making post JCA – 2025 Workshop Report
A CIRS-Utrecht University workshop explored different stakeholders’ early experiences of Joint Clinical Assessment (JCA), considering practical implementation of JCA outputs into national HTA decision making.Download the full workshop reportBackground Since …
Evaluation of decision making practices at ZAMRA – Chisha 2026
This peer-reviewed publication, co-authored by researchers from the Zambia Medicines Regulatory Authority (ZAMRA), CIRS, and the University of the Witwatersrand, evaluates the quality of decision making practices used by ZAMRA’s …
Patient Involvement in the Asia Pacific – 2026 Workshop Synopsis
This CIRS multi-stakeholder workshop examined strategies for embedding meaningful patient engagement and patient experience data in regulatory and HTA processes in the Asia-Pacific.
CIRS RD Briefing 104 – Class 1 Innovative Medicines Approved in China: An International Comparison
As pharmaceutical innovation becomes increasingly global, companies are pursuing multi-jurisdictional approvals and timely patient access through evolving regulatory and reimbursement pathways. In China, regulatory reforms and expanded use of expedited …
What the MHRA-NICE aligned pathway could mean for development and access in England
A CIRS commentary drawing on comparative research to examine the MHRA-NICE aligned pathway following its implementation in England. Since 1 April 2026, the MHRA-NICE aligned pathway has been fully operational, …
Navigating national decision making post JCA – 2025 Workshop Synopsis
A CIRS-Utrecht University workshop explored different stakeholders’ early experiences of Joint Clinical Assessment (JCA), considering practical implementation of JCA outputs into national HTA decision making.Background Since January 2025, national HTA …
Review of 2025 CIRS activities
We’re pleased to share a high-level summary of what CIRS got up to last year, including key research outputs and meetings. Our full 2025 Annual Report will be published in …
Parallel Submissions in Australia and Canada – Sola-Barrado 2026
As companies navigate diverse global HTA environments, new CIRS analysis provides timely evidence on the role of parallel regulatory/HTA submissions. Our latest publication in the International Journal of Technology Assessment …
Examining the UK HTA Landscape for Orphan Medicines
To mark Rare Disease Day on 28 February, we’re sharing findings from our work examining how orphan new active substances (NASs) are assessed by two of the UK’s HTA agencies …
Patient Involvement in Regulatory and HTA Decision Making – 2025 Workshop Report
This CIRS multi-stakeholder workshop examined strategies for embedding meaningful patient engagement and patient experience data in regulatory and HTA processes.