Background: This study was built on the previous 2018/2019 assessment where ICH selected the Centre for Innovation in Regulatory Science (CIRS) to collaborate on the development and the conduct [...]
This Briefing presents data from HTADock, an ongoing metrics study that collects data on new active substances (NASs) appraised by eight HTA agencies and analyses synchronisation between the regulatory [...]
We’re thrilled to welcome Anna Somuyiwa as the new Head of CIRS! Anna will lead the CIRS team in its mission to maintain a leadership role in identifying and [...]
Background: The aims of this study were to compare the overall regulatory review timelines achieved by the South African Health Products Regulatory Authority (SAHPRA) in 2020 to the timelines historically [...]
This workshop was part of a series of global development workshops that brought together mature and maturing regulatory agencies. These workshops successively built on one another and evolved from [...]
We’re thrilled to welcome Belén, Adem and Juan to the CIRS team! As our HTA Research Analyst, Belén will be supporting core HTA projects, such as our annual HTA [...]
An increasing number of National Regulatory Authorities (NRAs) are turning to reliance as a way to conserve resources, build expertise and capacity, increase the quality of their regulatory decisions, [...]
This Briefing presents the results from the CIRS annual analysis of New Active Substance (NAS) approvals by six major regulatory agencies: the European Medicines Agency (EMA), the US Food [...]
We're delighted to present our latest Annual Report, which provides a summary of CIRS projects and workshops undertaken in 2020 as well as case studies depicting CIRS’ impact on [...]
Although it cannot be expected that different medicines’ regulatory agencies always reach the same review outcome, it is important that decision making is documented and communicated to ensure transparency. [...]
