Background: This study explored the readiness and strategic considerations of companies and key stakeholders for the implementation of the Joint Clinical Assessment (JCA) under the European Health Technology Assessment [...]
Take a look at our latest newsletter, which shares updates on key research activities and publications in the first quarter of 2025. Download newsletter
This R&D Briefing builds upon the Centre for Innovation in Regulatory Science (CIRS)'s long-standing efforts to examine trends and practices in regulatory approvals. For over 20 years, CIRS has [...]
Background and Objectives The inherited backlog of 16,000 medicines applications of the South African Health Products Regulatory Authority (SAHPRA) was cleared through facilitated review pathways that included reliance on [...]
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 2024 Annual Report will be published [...]
We're pleased to announce that CIRS has published a new Research Agenda, which can be downloaded here. This brochure outlines our research priorities for 2024-2026 as well as plans [...]
Background In 2012, the East African Community Medicines Regulatory Harmonization (EAC-MRH) initiative was established to improve access to safe, effective, and high-quality medical products to patients in the East [...]
This R&D Briefing presents data from HTADock, an ongoing CIRS metrics study that collects publicly available data on new active substances (NASs) appraised by key international HTA agencies. It [...]
In recognition of Rare Disease Day today, we wanted to share what CIRS has been up to recently to help advance regulatory and HTA policies and processes in the [...]
Introduction: When implemented by national and regional regulatory agencies good review practices (GRevPs) support the timely high-quality review of medicines for enhanced patients’ availability to safe, quality and efficacious [...]
