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 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 [...]
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 [...]
Background: The Gulf Centralised Committee for Drug Registration (GCC-DR), as part of the Gulf Health Council (GHC), enables the consolidated registration of pharmaceutical products throughout the member states of [...]
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 [...]
Introduction: The common technical document (CTD) format harmonised the requirements for the registration of medicines, which had traditionally differed from country to country, making it possible for countries to [...]