PO 8475 ENHANCING THE CAPACITY OF THE LIBERIA MEDICINES AND HEALTH PRODUCTS REGULATORY AUTHORITY IN POST-MARKETING SURVEILLANCE OFIN VITRODIAGNOSTICS

Abstract

BackgroundThe Quality Control Laboratory (QCL) of the Liberia Medicines and Health Products Regulatory Authority (LMHRA) lacks capacity to assess the quality of in vitro diagnostics (IVDs). The LMHRA needs be strengthened to develop post-market surveillance (PostMS) regulations in order to fulfil its supervisory role for IVDs used in research and healthcare settings. IGORCADIA, an EDCTP-funded project of LMHRA and the Barcelona Institute for Global Health (ISGlobal) started in December 2017 with the aim of building LMHRA diagnostics assessment capacity.MethodsProject activities targeting the QCL include: the constitution of an in-house Technical Working Group and a Diagnostic Steering Committee involving national stakeholders to develop PostMS regulation; a Training Programme in Diagnostics Research (TPDxR) including a malaria diagnostics performance study as its post-TPDxR exercise.ResultsThe QCL is developing with its new knowledge and networks improved mechanisms to enact its supervisory mandate. QCL staff contributed to the development of guidance for Post-MS. Private sector and government stakeholders helped the LMHRA identify unlicensed premises where IVDs of presumably poor accuracy are available over the counter. Following the TPDxR, the QCL planned quality assurance to oversee the quality assessments on suspected substandard IVDs. Quality control tools, staff training requirements, standard inspection procedures, and PostMS registers and reports were re-designed in accordance with Good Laboratory Practice and guidance from the TPDxR.ConclusionThe LMHRA is strengthening its regulatory, inspection and PostMS capacities thanks to a partnership with a European research institution with expertise in malaria diagnostics development. To ensure that the Liberian population has access to safe quality diagnostics in routine healthcare provision and in future infectious diseases outbreaks, it is of utmost importance that the LMHRA has capacity to assess the accuracy of the non-WHO prequalified IVDs that are currently available outside the healthcare system, and is well-equipped to recall those IVDs identified as substandard.