Objectives Regulators must balance medicine benefits and risks while ensuring consistency, transparency, and efficiency in decision-making and the aim of this study was to assess UMBRA’s impact on SAHPRA [...]
Objectives To identify the current perspective of the FDA Ghana in the implementation of Good Review Practices, provide a baseline on the knowledge, attitudes, practices, as well as identify [...]
Objectives 1. To investigate ways in which the regional initiative could be well coordinated.2. To propose an improved model for the East African Medicine Regulatory Harmonisation Initiative joint assessments.3. [...]
Objectives To assess the quality of the decision-making process followed by regulatory reviewers, explore their perceptions of the Zambia Medicines Regulatory Authority (ZAMRA) decision-making approach, and evaluate the usefulness [...]
This CIRS multi-stakeholder workshop examined success factors for strengthening regulatory systems to support the implementation of collaborative models.
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 [...]
Background: This study explored the readiness and strategic considerations of companies and key stakeholders for the implementation of the Joint Clinical Assessment (JCA) under the European Health Technology Assessment [...]
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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 [...]
