Get Involved – Regulatory Agencies & HTA Bodies
Why CIRS?
CIRS is a trusted source of regulatory and HTA insights and knowledge. For over 30 years we have worked with agencies of all sizes from around the world to facilitate change, either within their organisations or more widely in the regulatory and HTA landscape.
Agencies who engage with us become part of an international community sharing insights and knowledge through research, benchmarking metrics projects and multi-stakeholder activities such as workshops.
There is no fee for agencies to access our insights and tools, or to engage with our research activities (see CIRS Research Agenda for more information). Please note that participation in our workshops and other meetings is by invitation only.
How can my agency get involved with CIRS?
CIRS regularly publishes insights from its research and meetings, which can help agencies to better understand the regulatory and HTA landscape and identify best practices. These insights are freely available on the CIRS website and take several forms:
- R&D Briefings – research papers produced by the CIRS team e.g. annual regulatory and HTA agency benchmarking briefings
- Journal articles – peer reviewed academic research papers (often co-authored with agencies)
- 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
You can also be kept up to date with our latest research by signing up to our mailing list.
In addition, agencies can request access to the CIRS Regulatory and Reimbursement Atlas, which provides insights on the diverse global regulatory and reimbursement landscape. Developed in collaboration with regulators, HTA agencies and payer organisations, Atlas illustrates the sequence of agency interactions in over 70 jurisdictions and the core functions of each agency involved.
CIRS has developed and validated several tools in collaboration with regulatory and HTA agencies to enhance their internal practices and processes. These include metrics tools that provide evidence-based insights into agency performance, and tools to support decision making (see below).
CIRS regularly conducts research using agency data, either collected from the public domain or directly from agencies. We have over 30 years’ experience in doing this and where possible, work collaboratively with agencies to validate our methodologies and results.
Our metrics studies give an independent insight into agency performance and can be used to inform agency strategies and identify areas for improvement. This includes work under the Optimising Efficiencies in Regulatory Agencies (OpERA) Programme as well as our annual agency benchmarking studies that compare selected agencies with similar mandates and processes.
We also undertake survey-based research to understand agency perspectives and the challenges they are facing globally. This helps to inform the discussions at our workshops and meetings, as well as future research. For example, we are currently surveying agencies for their perspectives on the impact, measurement and future direction of patient engagement in regulatory and HTA decision making. Insights from this survey will be shared and discussed at the October 2025 patient engagement workshop.
Engaging with other agencies and stakeholders in a safe harbour environment through CIRS workshops provides opportunities to understand the global policy landscape, raise issues and identify possible solutions. We also hold dedicated forums for only regulatory agencies and for HTA agencies.
To foster productive discussions, our meetings are kept small and focused, often featuring breakout sessions that are key to generating recommendations to help effect change in pharmaceutical policy. Due to this format, we must be selective about participants, basing invitations on the meeting topic, location and stakeholder balance. We make our workshop reports public so everyone can access the outcomes and recommendations.
Our research provides the evidence basis for our workshops and meetings, which in turn generate new ideas and areas for further research.
In addition to its core research activities, CIRS can be commissioned to undertake ‘Special Projects’ in collaboration with or on behalf of agencies. The aims, methods and outcome of each project can be adapted to meet agencies’ unique needs and goals, such as to support internal strengthening efforts and promote best practices. For example, we have conducted studies in collaboration with the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) to monitor the implementation and adherence to ICH guidelines by regulatory authorities.
