CIRS 2023 Annual Report
We're delighted to present our latest Annual Report, which provides a summary of the projects, publications, multi-stakeholder workshops and Technical Fora from Regulatory and HTA workstreams undertaken in 2023. [...]
CIRS RD Briefing 94 – Value of Reference Agency Reports in Enabling Reliance
Access to information, including the assessment documents of reference national regulatory agencies (NRA), is a key enabler of regulatory risk-based decision making. It promotes an understanding of what was [...]
2024 Workshop Synopsis – What is needed for risk-based approaches to work effectively and efficiently?
In this workshop, CIRS brought together senior representatives from regulatory agencies, pharmaceutical companies and academia from 18 countries across the Americas, Africa, Asia and Europe, to examine risk-based approaches [...]
CIRS RD Briefing 92 – Appraising the usability of public assessment reports for reliance
Regulatory reliance facilitates regulatory approvals, allows the use of resources more efficiently, and ultimately serves patients by accelerating access to quality-assured, safe, and effective medicines. The World Health Organisation [...]
Establishing a baseline for monitoring the impact of the EU HTA Regulation
Timely availability of new medicines to patients is crucial for public health. This process involves several phases: the time taken for regulatory approval, the time to health technology assessment [...]
2023 Workshop report – Review and reimbursement frameworks for rare disease products
There are an estimated 300 million people across the world affected by around 7000 known rare diseases. Challenges in bringing treatments to market for these conditions include small patient [...]
New CIRS Research Agenda
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 for [...]
Webinar on approaches to implementing regulatory reliance
We recently presented key findings from our latest R&D Briefing in a webinar on 'Approaches to Implementing Regulatory Reliance: Considerations for Agencies'. The webinar was attended by over 200 people [...]
2023 Workshop report – Uncertainty in the development of new medicines
This CIRS workshop brought together companies and agencies (HTA and Regulatory) to discuss the sources of uncertainty that are being built in, by the way medicines development has evolved [...]
2023 Workshop Synopsis – Regulatory and reimbursement frameworks for rare disease products
This multi-stakeholder workshop consisted of a series of presentation sessions and three parallel breakout discussions. Presentations explored trends in regulatory and HTA approvals of orphan products [...]