Monrovia – The Liberian Medicines and Health Products Regulatory Authority (LMHRA), in collaboration with stakeholders, has concluded a five-year strategic plan (2021-2025) for the effective governance and implementation of drug regulation. drugs in Liberia; and to ensure that safe, effective and quality medicines are provided to the population.
To make a formal presentation of the strategic plan to a cross-section of stakeholders and donor partners, during a one-day introductory stakeholder meeting, held at the Cape Hotel in Monrovia, the LMHRA Chief Executive Officer, Pharmacist Keturah Smith-China, noted that without a guidance tool for medicines regulation, the country will not have the desired quality of healthcare services, therefore, it is high time for the narrative to change supporting the regulatory authority as it should be because it is the genesis of quality health care.
“So over the next five years, the LMHRA wants to change the narrative of how regulations are implemented not just in Liberia, but in the sub-region. Because if there is a bad system in place, the population may not have the quality of health care desired by all”, underlined the director general of the LMHRA.
She added: “As we go through these plans, we pray that our partners take note and begin to support wherever they can, as planned by the LMHRA over the next five years.”
Giving an overview of the LMHRA, Dr. Flomoku Miller, Technical Advisor to the Director General of the LMHRA, noted that to ensure that the national drug supply system is safe, efficient and that good quality drugs reach the Liberian public, LMHRA continues to audit pharmaceutical manufacturers for good manufacturing practices; carries out an evaluation of the medicinal files by means of a CTD evaluation; issue marketing authorization and conduct quality control and assurance activities and monitor drug safety.
According to him, to protect the Liberian public from the harmful effects of substandard and counterfeit medicines and health products, the LMHRA conducts container inspections, post market surveillance premises inspections, anti-trafficking drugs through confiscation, community and school awareness, radio broadcasts, billboards. facilities, posting awareness messages on LMHRA website notices, overseeing product recalls, incinerating expired products and confiscating medicines and health products from peddlers.
The LMHRA Technical Advisor further hinted that since the rise of the current management team, there has been the establishment of new departments, new units, sub-offices, regional offices, recruitment staff, capacity building of staff, purchase of vehicles and other logistical equipment, erection of structures, drafting of new guidelines and regulations as well as drafting of the new strategic plan.
Despite these described achievements, Dr. Miller decried the challenges faced by the LMHRA such as complete decentralization of the entity, understaffing of departments, with technical staff, limited logistics especially vehicles, space for work, software for the various technical departments, completion of the quality control laboratory infrastructure, as well as functional equipment, and a certified quality control laboratory and further capacity building.
When the Authority was set up in 2010, an initial strategic plan for 2011-2013 was drawn up to guide the first five years of the LMHRA’s existence.
Highlighting the 2021-2025 five-year strategic plan, United States Pharmacopeia PQM+ consultant Benjamin Kwame Botwe said the five-year plan was developed based on the mandate given by the law establishing the LMHRA as well as experiences and lessons learned over the past ten years. years of existence of the authority, international best practices and the results of some internal and environmental assessments undertaken so far.
According to him, the purpose of this strategic plan is to: design strategies to achieve the vision, mission and objectives of the authority; provide a long-term perspective of what authority would look like in the future; develop performance indicators for monitoring and evaluation; the development of an operational plan and budget as a basis for seeking technical and financial assistance to facilitate the achievement of these set objectives.
The USP PQM+ consultant further mentioned that the process of developing the strategic plan involved an assessment of the status of implementation of the first strategic plan; the LMHRA’s self-assessment of its regulatory functions using the World Health Organization (WHO) global benchmarking tools; further assessment of the status of quality management systems by the West African Health Organization (WAHO); all levels of management, staff and various stakeholders and professional groups were solicited for their input and buy-in. He said that after carrying out a SWOT and PESTEL analysis, the vision and mission statements were developed and the strategic objectives were identified to be able to achieve the mission of the authority.
Some of the thematic areas addressed in the plan include regulatory system strengthening, legislation and regulation, evaluation and registration, inspections, import and export control, post-marketing surveillance, pharmacovigilance and clinical trials, quality control, quality management system, human resource development, harmonization, collaboration and decentralization, financial sustainability, communication and information technology.
Mr. Botwe also pointed out that the plan also encompasses the establishment of an effective and efficient regulatory system for medicines and related products; setting up a quality management system and carrying out operational research activities to support regulatory functions; development and implementation of an effective information management system; promotion of partnership, cooperation, collaboration and decentralization; recruiting, developing and maintaining adequate human resource capacity and mobilizing technical and financial resources for the implementation of regulatory functions.
In conclusion, Mr. Botwe underlined that the regulation of medicines and health products aims to ensure safety, efficacy and quality. Therefore, marketing authorization, post-marketing surveillance, inspections and quality control laboratory activities require state-of-the-art infrastructure, well-trained and qualified human resources as well as technical assistance. and financial. According to him, the accompanying strategic and operational plan is costed to provide opportunities for investment in particular areas and, where necessary, provide technical assistance to achieve the objectives, because experience shows that the budgetary allocation government alone is not enough to ensure full implementation of the plan.
Also speaking, the Director of USP-Ghana and PQM+ West Africa, Mr. Kwasi Poku Boateng, pointed out that USP PQM+’s support to the LMHRA includes the establishment of the LMHRA, the implementation of an aspect of the first strategic plan, provision of technical assistance funding from USP, development of the current strategic plan, support to key regulatory functions, support for evaluation and product registration, PMS staff training, malaria control compliance training, quality control laboratory support and inspection department capacity building.
PQM+ is working with LMHRA to strengthen its ability to perform regulatory functions. PQM+ also helped LMHRA to develop its current five-year strategic plan (2021-2025) to strengthen the governance of the medical product quality assurance system.
In addition, the program assists in drafting regulations to strengthen LMHRA enforcement actions and drug registration and importation, as well as improving the capacity of the national quality control laboratory to undertake a post-marketing surveillance to monitor the quality of medical products in circulation. and increase their source of income.
For their part, representatives of the World Health Organization (WHO), the Global Fund, UNICEF, the United Nations Development Program (UNDP), USAID and other partners congratulated the management of the LMHRA and the USP PQM+ for the implementation of the five-year mandate of the regulatory authority. strategic plan; pledging to work with the LMHRA to see the authority achieve its desired goals and targets.
