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 [...]
During the DIA Global Annual Meeting 2023, Adem Kermad, Magda Bujar and Neil McAuslane developed and presented a poster in which they shared the results, recommendations and conclusions about [...]
During the DIA Global Annual Meeting 2023, Nancy Yang-Ngum developed and presented a poster in which she shared the results, recommendations and conclusions about the topic "Evaluation of the [...]
During the DIA Global Annual Meeting 2023, Mercy Owusu-Asante developed and presented a poster in which she shared the results, recommendations and conclusions about the topic "Evaluation of the [...]
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 [...]
During the DIA Global Annual Meeting 2023, Tariro Sithole, Nancy Ngum, Mercy Owusu-Asante, Stuart Walker and Sam Salek developed and presented a poster in which they shared the results, [...]
Consensus of regulatory decisions on the same Marketing Authorization Application (MAA) are critical for stakeholders. In this context, regulatory decision patterns from the Swissmedic (SMC), the US Food and [...]
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 [...]
Over the last 20 years, CIRS has been developing regulatory science tools to increase transparency of processes, support quality regulatory decision making, and provide global advocacy in support of [...]