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 [...]
There is a growing interest in aligning accelerated regulatory pathways with flexible access and reimbursement pathways to expedite the equitable availability of high-quality, safe, and effective medicines that provide [...]
In November 2018, a collaborative forum presented by CIRS and the Utrecht University WHO Collaborating Centre for Pharmaceutical Policy and Regulation brought together regulatory, HTA, industry and academic perspectives [...]
The aim of this workshop was to bring together companies, patient representatives and HTA, payer and regulatory agencies to discuss current perspectives and opportunities for Facilitated Regulatory Pathways (FRPs) [...]
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 [...]
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 [...]
