Background: Following the establishment of Economic Community of West African States Medicines Regulatory Harmonization (ECOWAS-MRH) initiative in 2017, it was considered timely to carry out an evaluation of the current [...]
In 2020, coronavirus disease (COVID-19) spread rapidly around the world and halted regular social, business, and research activities. The pandemic impeded normal functioning across several fields, and businesses and [...]
This workshop looked at how maturing markets are building risk-based approaches into regulatory assessment, building on recent CIRS workshops in Singapore (2019) and South Africa (2018). The workshop also [...]
This workshop builds on the outcomes of the CIRS Professor Breckenridge memorial workshop in December 2020, as well as the 2021 workshop on utilisation of digital technologies in clinical [...]
As regulatory systems mature with demand for new innovative treatments, jurisdictions are seeking to introduce more comprehensive healthcare systems; this is often accompanied by efforts to initiate health technology [...]
Background: The West Africa Health Organization launched the West Africa Medicines Regulatory Harmonization Project (WA-MRH) in 2017 with the overarching objective to improve the availability of high-quality, safe and [...]
Purpose: This study aimed to assess the current regulatory review process of the food and drugs authority (FDA) Ghana by identifying key milestones, target timelines, good review practices and [...]
Background: A 2021 study to determine the viewpoints among the seven member countries regarding the effectiveness (i.e., achieving the intended outcomes) and efficiency (i.e., achieving the intended outcomes in [...]
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 [...]
