Regulatory

Testing the UMBRA benefit-risk tool in a South African agency

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 [...]

2025-07-02T11:24:46+00:00July 2nd, 2025|Tags: , , , |

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 [...]

2025-07-02T11:12:16+00:00July 2nd, 2025|Tags: , , |

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. [...]

2025-07-02T09:20:16+00:00July 2nd, 2025|Tags: , , , |

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 [...]

2025-07-02T08:50:46+00:00July 2nd, 2025|Tags: , , , |

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 [...]

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