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) [...]
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 [...]
We are pleased to share the latest CIRS newsletter with you, providing an update on our recent activities, research outputs, and upcoming work across medicine regulation and HTA. 🔍In [...]
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 [...]
Watch Webinar Recording Join us for a webinar on regulatory reliance on Tuesday 30 June 9 AM Mexico 10 AM Colombia, Ecuador, Peru, EST 11am Chile 12 PM Argentina, [...]
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 [...]
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 [...]
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.
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 [...]
