An independent perspective on the East African Community Medicines Regulatory Harmonisation initiative

African regulators are taking bold transformative steps to optimise the effective and efficient use of their agency resources to assure access to quality, safe and effective medicines. In particular, [...]

2020-08-18T08:33:28+00:00August 18th, 2020|Tags: , |

Keyter et al 2020 – Can standardisation of the Public Assessment Report improve benefit-risk communication?

Background: National regulatory authorities (NRAs) make the decision to register a medicine based on an assessment of its benefits and risks and publicly available assessment reports are used as [...]

2020-10-12T10:52:42+00:00June 18th, 2020|Tags: , , |

Sithole et al 2020 – Evaluating the success of ZaZiBoNa

The Southern African Development Community (SADC) collaborative medicines registration initiative ZaZiBoNa is a successful regional work-sharing initiative on the African continent. This paper reviews the history of the ZaZiBoNa [...]

2020-10-12T10:51:39+00:00May 19th, 2020|Tags: , , |

Keyter et al 2020 – Implementation of a Framework for an Abridged Review Using Good Reliance Practices: Optimising the Medicine Regulatory Review Process in South Africa

Background This study sought to identify criteria and current practices for implementing an abridged review process and understanding barriers and enablers in utilizing reliance models and to offer recommendations [...]

2020-10-12T10:50:45+00:00March 25th, 2020|Tags: , , |

Keyter et al 2019 – Evaluation of the performance of the South African regulatory agency

Background Timely access to new medicines may be addressed through strengthening of registration efciencies and timelines by establishing and refning value-added registration processes, resources, and systems. The aims of this [...]

2020-10-12T10:48:48+00:00December 12th, 2019|Tags: , , |

Keyter et al 2019 – South African Medicines Control Council: Comparison of Its Registration Process

Introduction: Comparisons between regulatory authorities of similar size and regulatory characteristics facilitate value-added benchmarking and provide insight into regulatory performance. Such comparisons highlight areas for improvement as authorities move [...]

2020-10-12T10:44:24+00:00March 14th, 2019|Tags: , , |