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 workshop brought together companies and agencies (HTA and Regulatory) to discuss the sources of uncertainty that are being built in, by the way medicines development has evolved [...]
This multi-stakeholder workshop consisted of a series of presentation sessions and three parallel breakout discussions. Presentations explored trends in regulatory and HTA approvals of orphan products [...]
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 [...]
We’re thrilled to welcome Penelope Cervelo as the new CIRS Research Analyst! Penelope will work closely with Dr Tina Wang and Dr Belen Sola on HTA projects and activities, [...]
CIRS brought agencies and companies together in a workshop to discuss new ways of working and how the regulatory and HTA landscape in mature and maturing countries should evolve [...]
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: [...]
Background: Swissmedic is a major regulatory agency that has been benchmarking its timelines for 20 years. To better understand the Swissmedic review times and to examine whether measures introduced to [...]
The document ‘Estrategia sobre Certidumbre Regulatoria para el Sector Farmacéutico’ (Strategy of Regulatory Certitude for the Pharmaceutical Sector), published last January by COFEPRIS describes important working projects the agency [...]
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 [...]
