HTA Regulation

CIRS R&D Briefing 105 – HTA Landscape under the EU HTA Regulation

Baseline mapping of national HTA authorities across the EU and EEA The EU Health Technology Assessment Regulation (HTAR) has moved from policy to practice, with Joint Clinical Assessments (JCAs) [...]

2026-07-22T09:12:10+00:00July 22nd, 2026|Tags: , |

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, [...]

2026-01-07T16:23:29+00:00January 7th, 2026|Tags: , , , , |

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 [...]

2025-12-10T12:20:13+00:00August 11th, 2025|Tags: , , , |

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 [...]

2026-03-03T15:25:56+00:00April 15th, 2025|Tags: , , |

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 [...]

2025-12-09T15:06:32+00:00November 28th, 2024|Tags: , , , |
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