PREFACE: The role of regulatory authorities in the health system is to ensure the quality, safety and efficacy of medical products. It is acknowledged that regulatory authorities are at [...]
Background: For almost a decade, the East African Community has implemented the Medicines Regulatory Harmonization (EAC-MRH) programme among its member states to harmonise technical requirements and standards for medical [...]
This Briefing presents the results from the CIRS annual analysis of new active substance (NAS) approvals by six major regulatory agencies: the European Medicines Agency (EMA), the US Food [...]
An increasing number of National Regulatory Authorities (NRAs) are turning to reliance as a way to conserve resources, build expertise and capacity, increase the quality of their regulatory decisions, [...]
This Briefing presents the results from the CIRS annual analysis of New Active Substance (NAS) approvals by six major regulatory agencies: the European Medicines Agency (EMA), the US Food [...]
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 [...]
