Regulatory-HTA alignment

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 [...]

2024-11-28T14:31:01+00:00November 28th, 2024|Tags: , , , |

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 [...]

2024-08-21T09:04:59+00:00August 21st, 2024|Tags: , , , , |

CIRS RD Briefing 89 – Review of HTA outcomes and timelines in Australia, Canada, Europe and the UK 2018-2022

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 [...]

Regulatory, HTA and company interactions: the current landscape and future ecosystem for drug development, review and reimbursement

Background: Multi-stakeholder interactions have evolved at product and policy levels. There is a need to assess the current and future landscape of interactions between companies, and regulatory and HTA agencies [...]

2023-10-31T16:46:26+00:00April 30th, 2023|Tags: , |

Evolution of HTA practice and approaches from the perspectives of HTA agencies and pharmaceutical industry

Health technology assessment (HTA) has emerged as an important tool to support healthcare decision-makers to make rational reimbursement decisions, with the ultimate purpose of promoting an efficient healthcare system. [...]

2023-09-20T08:56:03+00:00December 31st, 2022|Tags: , |
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