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 [...]
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 [...]
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, [...]
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 [...]
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 [...]
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 [...]
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 [...]
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 [...]
This CIRS multi-stakeholder workshop examined strategies for embedding meaningful patient engagement and patient experience data in regulatory and HTA processes.
This journal article co-authored by CIRS, AUDA‑NEPAD, the African Medicines Agency (AMA), and University of Hertfordshire, reviews the development of the African Medicines Agency (AMA), tracing its evolution from [...]
