HTA Submission Trends for EMA-Approved Oncology Medicines 2018-2023
How quickly do oncology medicines move from EMA approval to HTA submission across Europe — and how might this change under the EU HTA Regulation? At ISPOR Europe 2025, [...]
CIRS RD Briefing 103 – Review of HTA outcomes and timelines in Australia, Canada, Europe and the UK, 2020-2024
This R&D Briefing presents findings from HTADock, an ongoing CIRS metrics study that collects publicly available data on new active substances (NASs) appraised by 12 HTA agencies in Australia [...]
Workshop Report – Regulatory and HTA collaborative models
In this workshop, CIRS brought together senior representatives from regulators, HTA agencies, pharmaceutical companies, payers, academics and patient organisations to discuss the impact of regulatory and HTA collaborative models [...]
CIRS RD Briefing 98 – European HTA trends: HTA outcomes and timelines across seven markets 2019-2023
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 [...]
Workshop Synopsis – Regulatory and HTA collaborative models
In this workshop, CIRS brought together senior representatives from regulators, HTA agencies, pharmaceutical companies, payers, academics and patient organisations to discuss the impact of regulatory and HTA collaborative models [...]
Frequency and Variation of Clock-Stop During EMA Assessment for Oncology Products – Implication on JCA Timelines
Objectives: The implementation act adopted for the HTA Regulation (HTAR) defined the timelines of scoping, submission and assessment and output of Joint Clinical Assessment (JCA), which will be in [...]
CIRS RD Briefing 96 – Review of HTA outcomes and timelines in Australia, Canada and the UK 2019-2023
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. It focuses [...]
CIRS RD Briefing 95 – Review of HTA outcomes and timelines in Australia, Canada, Europe and the UK 2019-2023
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 [...]
Rare Disease Product Approvals: The Changing Regulatory And HTA Landscape Between 2018-2022
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 [...]
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 [...]