The Ministry of Health (MOH) in Eswatini holds the responsibility of regulating and overseeing health products within the country, and this role is carried out through the Medicines Regulatory Unit (MRU). The Medicines & Related Substances Control Act of 20161 includes provisions for the establishment of an independent national medicines regulatory agency (NMRA), as recommended by the World Health Organization (WHO). However, progress towards setting up the NMRA has been slow. The MRU has been established to expedite the process of establishing the NMRA in Eswatini.
To address the disease burden effectively, Eswatini's healthcare system needs a well-functioning regulatory environment that ensures the quality, safety, and efficacy of medicines. This includes, but is not limited to, effective drug regulation, quality assurance mechanisms, pharmacovigilance programs, and strong supply chain management. Due to limited capacity and resources, Eswatini experiences a significant challenge in implementing robust health product regulatory activities.
As part of its work in Eswatini, PQM+ is working with the MRU to establish improved, sustainable systems for registration & market authorization/registration, inspection, licensing, post-marketing surveillance, and regulatory reliance networks. In addition, PQM+ is supporting the MRU to improve and expand the competency and efficiency of its workforce.