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 [...]
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.
Historical Review of the African Medicines Agency (AMA) – Ismail 2026
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 [...]
Patient Involvement in Regulatory and HTA Decision Making – 2025 Workshop Synopsis
This CIRS multi-stakeholder workshop examined strategies for embedding meaningful patient engagement and patient experience data in regulatory and HTA processes.
HTA Submission Trends for EMA-Approved Oncology Medicines 2018-2023
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, [...]
Assessing Good Review Practices in Zambia Medicines Regulatory Authority – Chisha 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 [...]
Incentivising Medicine Development for Chronic Diseases – Workshop Report
This CIRS multi-stakeholder workshop examined strategies for incentivising the development of medicines for common chronic diseases.