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: , |

CIRS RD Briefing 68: Regulatory and HTA decision making and access to medicines – the consequences of sequence

Historically, every jurisdiction with some form of regulatory agency capacity has undertaken the review of medicines as a first step in the market access process. This step is intended [...]

Wang et al 2018 – Building Synergy between Regulatory and HTA Agencies

Objectives: To evaluate the current practice of companies and agencies to assess the changes made in aligning regulatory and health technology assessment (HTA) stakeholders; to identify areas of commonality [...]