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 [...]
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 [...]
This CIRS multi-stakeholder workshop examined strategies for embedding meaningful patient engagement and patient experience data in regulatory and HTA processes.
How quickly do oncology medicines move from EMA approval to HTA submission across Europe — and how might this change under the EU HTA Regulation? At ISPOR Europe 2025, [...]
Introduction: The implementation of Good Review Practices (GRevPs) ensures the timely, high-quality review and enhanced availability to safe, quality, and efficacious medicines. It is important, therefore, that all aspects of [...]
This CIRS multi-stakeholder workshop examined strategies for incentivising the development of medicines for common chronic diseases.
Background The World Health Organization (WHO) developed the WHO Global Benchmarking Tool (GBT) to assess and benchmark the drug regulatory systems and practices in national medicines regulatory authorities (NMRAs). [...]
