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 99 – First HTA outcomes and timelines for oncology medicines approved by EMA 2018-2023
This R&D Briefing presents data from HTADock, an ongoing CIRS benchmarking study that collects publicly available data on new active substances (NASs) appraised by key international HTA agencies. This CIRS [...]
Ensuring efficiency and effectiveness of Joint Clinical Assessment (JCA) – Wang 2025
Background: This study explored the readiness and strategic considerations of companies and key stakeholders for the implementation of the Joint Clinical Assessment (JCA) under the European Health Technology Assessment [...]
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 [...]
Workshop Report – Ensuring efficient and effective implementation of joint clinical assessment (JCA)
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 [...]
2024 Workshop Synopsis – Ensuring efficient and effective implementation of joint clinical assessment (JCA)
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 [...]
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 [...]