The Regulation (EU) 2021/2282 on health technology assessment (HTAR) reflects a significant step towards harmonising the clinical assessment in HTA decision making across EU Member States. It aims to [...]
In this workshop, CIRS brought together senior representatives from the international pharmaceutical industry, regulatory agencies, National Immunisation Technical Advisory Groups (NITAGs), HTA agencies, payers and academia to identify challenges [...]
In this workshop, CIRS brought together senior representatives from HTA agencies, pharmaceutical companies, payers and patient organisations to discuss their readiness for the EU HTA Regulation (HTAR) being applied [...]
This R&D Briefing presents data from HTADock, an ongoing metrics study that collects publicly available data on new active substances (NASs) appraised by key international HTA agencies, each with [...]
Background Globally, 7,000 rare diseases affecting 300 million people pose development challenges with small patient populations. Developing medicines for rare diseases requires innovation. Despite regulatory incentives, challenges for HTA [...]
The Centre for Innovation in Regulatory Science (CIRS) held a multi-stakeholder workshop that examined current regulatory and reimbursement frameworks for rare disease products (orphan drugs), reviewing how these can [...]
Background Pharmaceutical companies have been actively taking early scientific advice from health technology assessment (HTA) agencies during development, with the aim to understand the HTA evidentiary requirements. The evolving [...]
So far 2024 has been a busy year conference wise for CIRS! CIRS staff have presented work and/or moderated sessions at several conferences including DIA Europe, RAPS Euro Convergence, [...]
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 [...]
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 [...]
