This R&D Briefing builds upon the Centre for Innovation in Regulatory Science (CIRS)'s long-standing efforts to examine trends and practices in regulatory approvals. For over 20 years, CIRS has [...]
This R&D Briefing presents data from HTADock, an ongoing CIRS metrics study that collects publicly available data on new active substances (NASs) appraised by key international HTA agencies. It [...]
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. It focuses [...]
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 [...]
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 [...]
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 [...]
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 [...]
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 [...]
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 [...]
