Overview Between January 2025 and June 2026, 20 medicinal products entered the EU Joint Clinical Assessment (JCA) process, including seven medicines developed primarily by Chinese companies. These products represent [...]
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 [...]
The latest HTADock R&D Briefing examines HTA outcomes and timelines for new active substances reviewed between 2021 and 2025 by 12 HTA agencies across Australia, Canada, Europe, and the [...]
A new article authored by CIRS' Dr Tina Wang and Dr Neil McAuslane, together with Prof Jin Wang of the OmniChain Med Institute, has been published in the September [...]
Transparent and consistent benefit-risk assessment is fundamental to regulatory decision making and stakeholder confidence in medicines regulation. This study evaluated the application of the Universal Methodology for Benefit-Risk Assessment (UMBRA) [...]
How effectively are regulatory authorities in Latin America implementing regulatory reliance in practice? This report presents findings from the first phase of a CIRS research project, showing that reliance [...]
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.
Good Review Practices (GRevPs) are an important component of regulatory systems strengthening and support progress in World Health Organization (WHO) Global Benchmarking Tool (GBT) assessment. This poster was presented [...]
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 [...]
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 [...]
