Regulatory-HTA alignment

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: , |

Kühler et al 2019 – To what degree are review outcomes aligned for new active substances between the EMA and the US FDA?

Objective To compare review outcome alignment between European Medicines Agency (EMA) and US Food and Drug Administration (FDA) for medicines approved by both agencies in the time period 2014–2016. Design [...]

2021-01-18T17:13:15+00:00November 15th, 2019|Tags: , |
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