LMHRA Envisions ISO-17025 Accreditation & WHO Maturity Level-3 In Two Years

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Liberia’s Medicines and Health Products Regulatory Authority (LMHRA) Managing Director, Dr. Luke Bawo, has disclosed plans to ensure the authority meets the International Standard Organization (ISO-17025) accreditation as well as the World Health Organization (WHO) Maturity Level-3 within two years of his administration. ISO/IEC 17025 specifies requirements for the competency of the entity to carry out tests and calibrations, including sampling. It covers testing and calibration performed using standard, non-standard, and laboratory-developed methods. At the same time, the WHO Maturity Level-3 confirms a stable, well-functioning, and integrated regulatory system being instituted by a national regulatory agency. According to him, the pathway to attaining WHO Maturity Level-3, is for the LMHRA to work closely with WHO Country Office to revisit the previous self-assessment conducted using the Global Bench-Marking Tool; fully implement all Institutional Development Plans (IDPs) associated with each of the nine functions; ensure WHO conducts an onsite assessment and show proof that all regulatory functions assessed meets the requirements  and as well ensure WHO officially declare  LMHRA qualified and listed  to its approved “National Regulatory Authorities.” At programs marking the Official Turning-over of authority on Friday, May 3, 2024, in Monrovia, the MD disclosed immediate plans to collaborate with the Pharmacy Board of Liberia (PBL) and the Liberia Medical and Dental Council (LMDC), to do a nationwide mapping of all private medical facilities and pharmaceutical outlets in the country. Dr. Bawo also divulged the authority’s plans to conduct Post-marketing Surveillance, as well as Pharmacovigilance thus regulating the conduct of clinical studies and maintaining a registry of all medicines and health products registered and approved for use in the country. He also disclosed his administration’s willingness to partner with media houses and the state broadcaster to increase the visibility of the authority as well as foster strong support from the entity’s Board of Directors. Accordingly, Managing Director Bawo also indicated that his administration will provide current and unbiased information on medicines and health products; and further strengthen regulations on advertisement, promotion, and marketing by fully following the policies enshrined per the authority’s mandate. The LMHRA MD also noted that the authority will expand and strengthen regulations of other health products to include: allopathic medicines, herbal and homeopathic medicines, biological, blood and blood products, veterinary medicine, medical devices, narcotic and psychotropic and cosmetic and chemicals.  Lastly, Managing Director Bawo once again stressed the need to strengthening human resource through capacity building initiatives of all staff of the authority for effective productivity of the authority’s core functions. Outlining past achievements of her administration, LMHRA’s immediate-Outgoing Managing Director, Dr. Keturah Smith-Chineh, noted that the first action she took to improve LMHRA when she took over the helm of authority was to conduct a situational analysis through a desk-review of existing documentations and the holding stakeholders’ consultations. According to her, some of the key issues/challenges she encountered upon assuming office were inadequate office infrastructure, no level of testing in the quality control laboratory, inadequate institutional capacity and technical expertise for medicines and related products regulation and quality control. In outlining her achievements Dr. Smith-Chineh cited the promulgation of Regulations on Medical Devices, Regulations for Sub-contracting of Testing Services, Regulations on Variations on Medical Products, and the Regulations on Defects and Quarantine of Medicines and Health Products, among others. Two members of the Legislature graced the occasion and remarked separately, Representative Julie Fatorma Wiah, Chairperson of the House’s Standing Committee on Health and Senator Jonathan Boye Charles Sogbie, a member of the Senate Standing Committee on Health and Chair of the Senate Committee on Maritime, both pledged their unflinching supports to the LMHRA and as well vowed to ensure the amendment of the Act and increase the ability of the institution to function through budgetary support. For her part, Health Minister Dr. Louise Kpoto, promised to fully collaborate with the authority and ensure that the issue of too much waiver on donated products are properly channeled through the LMHRA. Other dignitaries to grace the turning over ceremony included: WHO Country Representative, Dr. Peter Clement; the Chief of Party of the Catholic Relief Service, Kerri Agee; Center for Disease Control Country Representative, Dr. Rachel Idowu, the Minister of State for Special Projects, Hon. Samuel Stevquoah, a representative of the Pharmaceutical Importers Association, Sam Dramani, amongst others.

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