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 [...]
Background and Objectives The inherited backlog of 16,000 medicines applications of the South African Health Products Regulatory Authority (SAHPRA) was cleared through facilitated review pathways that included reliance on [...]
Background In 2012, the East African Community Medicines Regulatory Harmonization (EAC-MRH) initiative was established to improve access to safe, effective, and high-quality medical products to patients in the East [...]
In recognition of Rare Disease Day today, we wanted to share what CIRS has been up to recently to help advance regulatory and HTA policies and processes in the [...]
Introduction: When implemented by national and regional regulatory agencies good review practices (GRevPs) support the timely high-quality review of medicines for enhanced patients’ availability to safe, quality and efficacious [...]
If you missed it, you can watch the full webinar here, available in Spanish, English and Portuguese. Join us for a webinar on public assessment reports (PARs) on [...]
Purpose: This study aimed to assess the current regulatory review process of the Zambia Medicines Regulatory Authority (ZAMRA) by identifying the key milestones and target timelines achieved for products [...]
In this workshop, CIRS brought together senior representatives from regulators, HTA agencies, pharmaceutical companies, payers, academics and patient organisations to discuss the impact of regulatory and HTA collaborative models [...]
Objectives: The implementation act adopted for the HTA Regulation (HTAR) defined the timelines of scoping, submission and assessment and output of Joint Clinical Assessment (JCA), which will be in [...]
More collaborative initiatives are taking place among regulatory agencies, health technology assessment (HTA) bodies and between regulatory and HTA agencies at national and regional levels. This blog by Martina [...]
