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 [...]
Access to information, including the assessment documents of reference national regulatory agencies (NRA), is a key enabler of regulatory risk-based decision making. It promotes an understanding of what was [...]
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 [...]
Regulatory reliance facilitates regulatory approvals, allows the use of resources more efficiently, and ultimately serves patients by accelerating access to quality-assured, safe, and effective medicines. The World Health Organisation [...]
We recently presented key findings from our latest R&D Briefing in a webinar on 'Approaches to Implementing Regulatory Reliance: Considerations for Agencies'. The webinar was attended by over 200 people [...]
This CIRS briefing delves into the increasingly pivotal role of regulatory reliance in the global pharmaceutical landscape. Reliance is defined by World Health Organization (WHO) as the act whereby [...]
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: [...]
Introduction: The World Health Organization (WHO) advocates the use of reliance practices to enable national regulatory authorities (NRAs) to improve patients’ access to medicines. This study considered whether reliance review [...]
During the DIA Global Annual Meeting 2023, Lorraine Danks, Boitumelo Semete-Makokotlela, Sam Salek and Stuart Walker developed and presented a poster in which they shared the results, recommendations and [...]
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 [...]
