We’re delighted to announce that we’ve been selected by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals (ICH) to undertake an assessment of regulatory agencies’ and companies’ perspectives [...]
Last week CIRS Head of Regulatory Collaborations and RAPS board member Dr Lawrence Liberti discussed "Challenges and Opportunities for Using Facilitated Regulatory Pathways (FRPs) in Mature and Emerging Markets" as [...]
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 [...]
Background: The Caribbean Regulatory System is a centralized medicine assessment procedure established to serve the needs of the Member States of the CARICOM region. In order to better understand [...]
Objectives: The objectives of the study were to establish a benchmarking tool to collect metrics to enable increased clarity regarding the differences and similarities across health technology assessment (HTA) [...]
We're delighted to present the inaugural CIRS Annual Report, which provides a summary of projects and workshops undertaken in 2019, as well as a historical perspective of CIRS achievements [...]
African regulators are taking bold transformative steps to optimise the effective and efficient use of their agency resources to assure access to quality, safe and effective medicines. In particular, [...]
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 [...]
As numerous factors have recently contributed to changes in the regulatory environment, we have been monitoring and analysing structural regulatory issues affecting overall access to medicines in the Latin [...]
Background: The development of a medicine is not only underpinned by good science but also by Quality Decision-Making Practices (QDMPs). Indeed, it is important to ensure that all organisations [...]