Assessing Good Review Practices at the FDA Ghana
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 [...]
Proposed Model for EAC MRH Joint Review
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. [...]
Evaluating Quality of Decision Making within the Zambia Medicines Regulatory Authority
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 [...]
Regulatory Collaboration and System Strengthening – Workshop Synopsis
This CIRS multi-stakeholder workshop examined success factors for strengthening regulatory systems to support the implementation of collaborative models.
Workshop Report – Regulatory and HTA 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 [...]
CIRS RD Briefing 97 – Access Consortium and Project Orbis Approvals Across Eight Regulators
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 [...]
Economic impact of reliance on an African regulator – Danks 2025
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 [...]
Suggested Improvements to the EAC-MRH Joint Review Process – Ngum 2025
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 [...]
Latest CIRS activities on rare diseases
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 [...]
Comparison of good review practices in ECOWAS – Owusu-Asante 2025
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 [...]