The Current State of in vitro Diagnostics Evaluation in Sub-Saharan African Countries: Insights from the Advanced Workshop.

Introduction: Although the African Union Development Agency-New Partnership for Africa's Development (AUDA-NEPAD) has initiated activities to support the establishment of a harmonized regulatory framework for in vitro diagnostics (IVDs), including those for testing blood and blood components, challenges such as limited infrastructure and insufficient technical expertise remain. The Global Health Protection Programme (GHPP) project BloodTrain, which seeks to strengthen regulatory systems for blood and blood products in Africa, addressed this by organizing an advanced workshop focused on IVD technical assessment. Data on national IVD regulatory systems were also collected through a structured questionnaire. Furthermore, a survey was conducted to evaluate both the perceived usefulness of the training and the applicability of the tools provided. Methods: An advanced training was conducted for personnel from 14 African national regulatory authorities who possessed prior knowledge and experience in the assessment of IVDs. The participants were also granted access to online courses on IVD technical file assessment. The workshop comprised theory and case study exercises by experts from TÜV Rheinland and BloodTrain, complemented by presentations from the participants on their national IVD regulatory systems. These presentations led to the development of a questionnaire to achieve a comparison of these regulatory systems. Results: In the survey, the workshop content resulted in a mean score of 4.5 on a 5-point scale. Lesser mean scores on workshop duration and previous knowledge to follow the workshop underline the need for additional training on IVD assessment. The comparative assessment of the regulatory criteria for IVDs collected by a post-workshop questionnaire showed the majority of the participating countries already had some level of regulation on IVDs, but there are still gaps that need to be addressed. Conclusion: The advanced IVD workshop provided well-appreciated training on IVD dossier assessment and also delivered understanding of the heterogenous regulatory landscape in the participating countries. While the questionnaire suggested that in most of the participating countries regulatory systems for IVDs are already in use, the survey painted a differentiated picture with heterogenous preexisting knowledge and the expectation that the trained content will be helpful in the future.