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 [...]
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 [...]
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 [...]
Purpose: This study aimed to assess the current regulatory review process of the Zambia Medicines Regulatory Authority (ZAMRA) by identifying the key milestones and target timelines achieved for products [...]
Introduction: Medicines regulatory harmonisation has been embraced by many national regulatory authorities (NRAs) to improve public health through faster availability of safe, high-quality, and effective medical products to patients [...]
Introduction: The East African Community Medicines Regulatory Harmonisation (EAC-MRH) programme was established to address challenges faced by national regulatory authorities (NRAs) of the region. Work sharing through joint assessments [...]
“This book teaches us important lessons that we will need to consider in our collaboration work with the African Medicines Agency. I am confident that this research will be [...]
So far 2024 has been a busy year conference wise for CIRS! CIRS staff have presented work and/or moderated sessions at several conferences including DIA Europe, RAPS Euro Convergence, [...]
Background The African Medicines Regulatory Harmonisation (AMRH) Initiative was formed in 2009 and subsequently, three regional initiatives (East African Community Medicines Regulatory Harmonisation [MRH], Southern African Development Community [SADC]/ZaZiBoNa [...]
Introduction: The World Health Organization (WHO) advocates the use of reliance practices to enable national regulatory authorities (NRAs) to improve patients’ access to medicines. This study considered whether reliance review [...]
