Publications
CIRS publishes insights from its research and meetings in several forms:
- R&D Briefings – research papers produced by the CIRS team e.g. annual regulatory and HTA benchmarking briefings
- Journal articles – peer reviewed academic research papers
- Reports – from CIRS workshops and externally commissioned research projects, as well as CIRS Annual Reports
- Books – research theses from CIRS-supported PhD students
- Posters – presented at external conferences
Keep up-to-date with CIRS publications and activities by signing up to our mailing list or following CIRS on LinkedIn.
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 reviewed …
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 in …
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 (WHO) …
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 (HTA) …
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 populations, …
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 and …
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 and perspectives on incentives …
CIRS RD Briefing 91 – Approaches to Implementing Regulatory Reliance: Considerations for Agencies
This CIRS briefing delves into the increasingly pivotal role of regulatory reliance in the global pharmaceutical landscape. Reliance is defined by World Health Organization (WHO) as the act whereby the …
Welcome our new HTA Research Analyst
We’re thrilled to welcome Penelope Cervelo as the new CIRS Research Analyst! Penelope will work closely with Dr Tina Wang and Dr Belen Sola on HTA projects and activities, such …
2023 Workshop report – New ways of working for medicines development
CIRS brought agencies and companies together in a workshop to discuss new ways of working and how the regulatory and HTA landscape in mature and maturing countries should evolve over …
HTA Timelines and Outcomes for MHRA-Approved NASs via Reliance/Work-sharing Routes
During ISPOR Europe 2023 in Copenhagen, Belen Sola presented a poster entitled ‘Study of HTA Timelines and Outcomes for MHRA-Approved NASs in the Post-Brexit UK via Reliance/Work-sharing Routes’. Background: Following …
Evaluation of the Swissmedic regulatory framework for new active substances
Background: Swissmedic is a major regulatory agency that has been benchmarking its timelines for 20 years. To better understand the Swissmedic review times and to examine whether measures introduced to accelerate …
CIRS RD Briefing 90 – Challenges and opportunities for orphan medicines availability in Mexico
The document ‘Estrategia sobre Certidumbre Regulatoria para el Sector Farmacéutico’ (Strategy of Regulatory Certitude for the Pharmaceutical Sector), published last January by COFEPRIS describes important working projects the agency will …