BackgroundEffective clinical trials oversight is a major function of a fully functional national medical products regulatory system. However, exercising clinical trial oversight in a resource-limited environment is challenging, in particular during an Ebola outbreak or health emergency. Until the devastating Ebola virus disease (EVD) outbreak in 2014, the Liberia Medicines and Health Products Regulatory Authority (LMHRA) had no capacity for effective clinical trial regulation. This presentation describes the main challenges encountered by LMHRA in regulating clinical trials in Liberia during the largest EVD outbreak that affected West Africa in 2014 and 2015.MethodsBy carefully documenting activities during the EVD outbreak, interviewing key stakeholders, and discussions among the LMHRA clinical trial committee, key challenges observed during the outbreak were identified and documented.ResultsLimited financial resources, lack of expertise in clinical trials, inaccurate and insufficient information about the functions of the LMHRA, poor coordination among key stakeholders, and the lack of a well-developed regulatory framework, adversely influenced the LMHRA clinical trial oversight performance during the EVD outbreak.ConclusionIt is true that several challenges need to be addressed when regulating a clinical trial in a limited-resource environment during any disease outbreak or international medical emergency. However, the importance of building local expertise in clinical trials through mentorship and training cannot be overemphasised. By taking advantage of grants from developmental partners, national medicines regulatory authorities in resource-limited environments can develop capacity for clinical research oversight.

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.