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 [...]
Developing a mechanism to monitor regulatory reliance globally
The WHO Good Reliance Practices (Annex 10) provide essential principles and considerations for regulatory reliance implementation. However, it is not clear how well agencies have been incorporating these principles [...]
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, [...]
Q1 2026 Newsletter
We're pleased to share the latest CIRS newsletter with you, featuring updates from our recent meetings, publications and research activities across medicine regulation and HTA. 🔍 What’s Inside: Patient [...]
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 [...]
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 [...]
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 [...]
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 [...]
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.