This R&D Briefing presents the results from the Centre for Innovation in Regulatory Science (CIRS) annual analysis of new active substance (NAS) approvals by six major regulatory agencies: the [...]
Introduction Over the last years, several regulatory agencies have developed risk-based approaches for the regulatory assessment of marketing authorisations of New Active Substances (NASs) as strategies to efficiently use [...]
In this workshop, CIRS brought together senior representatives from regulatory agencies, pharmaceutical companies and academia from 18 countries across the Americas, Africa, Asia and Europe, to examine risk-based approaches [...]
During ISPOR Europe 2023 in Copenhagen, Belen Sola presented a poster entitled ‘Study of HTA Timelines and Outcomes for MHRA-Approved NASs in the Post-Brexit UK via Reliance/Work-sharing Routes'. Background: [...]
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 [...]
This R&D Briefing presents the results from the Centre for Innovation in Regulatory Science (CIRS) annual analysis of new active substance (NAS) approvals by six major regulatory agencies: the [...]
Background: Despite the worldwide need for increased access to safe and effective medicines, there is a lack of innovative medicines in many low- to middle-income countries. On the African [...]
Background: Following the establishment of Economic Community of West African States Medicines Regulatory Harmonization (ECOWAS-MRH) initiative in 2017, it was considered timely to carry out an evaluation of the current [...]
This workshop looked at how maturing markets are building risk-based approaches into regulatory assessment, building on recent CIRS workshops in Singapore (2019) and South Africa (2018). The workshop also [...]
Background: The West Africa Health Organization launched the West Africa Medicines Regulatory Harmonization Project (WA-MRH) in 2017 with the overarching objective to improve the availability of high-quality, safe and [...]
