This CIRS workshop brought together companies and agencies (HTA and Regulatory) to discuss the sources of uncertainty that are being built in, by the way medicines development has evolved [...]
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 [...]
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 [...]
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 [...]
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. [...]
As regulatory systems mature with demand for new innovative treatments, jurisdictions are seeking to introduce more comprehensive healthcare systems; this is often accompanied by efforts to initiate health technology [...]
Over the last five years, regulatory and HTA interactions, as well multi-HTA and multi-regulatory interactions and collaborations, have evolved in thinking and mutual activities both at a product level [...]
For a new medicine to reach patients, it must achieve both regulatory marketing authorisation and reimbursement from the payer. Because regulators assess the benefits and risks of a medicine [...]
This workshop was a follow-on from a collaborative forum held in Utrecht in 2018 entitled What new research can enable a joint approach by regulatory and HTA agencies to [...]
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 [...]
