Regulatory-HTA alignment

Improving development, regulatory and reimbursement frameworks for rare disease products

This multi-stakeholder workshop consisted of a series of presentation sessions and three parallel breakout discussions. Presentations explored trends in regulatory and HTA approvals of orphan products [...]

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 [...]

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. [...]

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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