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.
From vision to reality: Two decades of progress in global drug development and regulatory innovation
Twenty years ago, participants at a CIRS workshop explored ideas that at the time appeared ambitious, including rolling reviews, facilitated regulatory pathways, collaborative assessments and real-time data sharing. Many of …
African Medicines Agency (AMA): Origins, Evolution and Future Prospects
This poster was presented at DIA 2026 and examines the development of the African Medicines Agency (AMA), tracing its evolution from the African Medicines Regulatory Harmonisation (AMRH) Programme to its …
CIRS 2025 Annual Report
The CIRS 2025 Annual Report highlights a year of independent research, global stakeholder engagement and evidence-based insights aimed at advancing regulatory and health technology assessment (HTA) policies and processes. Inside the …
CIRS R&D Briefing 105 – HTA Landscape under the EU HTA Regulation
Baseline mapping of national HTA authorities across the EU and EEA The EU Health Technology Assessment Regulation (HTAR) has moved from policy to practice, with Joint Clinical Assessments (JCAs) now …
Comparative review of 10 HTA systems – Dai 2026
Overview Health technology assessment (HTA) plays a key role in supporting evidence-informed healthcare decision making, pricing, reimbursement, and coverage decisions worldwide. As countries seek to strengthen health policy and resource …
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, …