Strengthening Liberia's Regulatory Authority |
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In Liberia, PQM+ is strengthening the country’s regulatory system with a focus on supporting the Liberia Medicines and Health Products Regulatory Authority (LMHRA) and its quality control laboratory. Recently, USAID through PQM+ donated several pieces of critical medicines testing equipment to the LMHRA. Liberian President George Manneh Weah attended the handover ceremony.
At the event, Jessica Healey, Health Officer, USAID Liberia, explained how the new equipment will enable the LMHRA to perform its own quality testing on medicines and health products rather than shipping samples to other countries for testing.
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“Conducting compendial testing in Liberia now will have several benefits,” Healey said. “It will be cheaper and faster. It means the lab is gradually moving towards sustainability because they will be able to generate funds from fees charged for sample testing.”
Substandard and falsified medicines undermine the country's ability to address malaria, maternal and child health concerns, family planning needs, and other health priorities. Using this new state-of-the-art testing equipment, LMHRA now can better assess the quality of medical products circulating in country.
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Nigeria's NAFDAC Achieves Maturity Level 3 Status |
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Nigeria’s National Agency for Food and Drug Administration and Control (NAFDAC) recently achieved Maturity Level 3 (ML3), becoming one of just four regulatory authorities in Africa to reach this milestone. The World Health Organization assesses regulatory authorities using the Global Benchmarking Tool – “an evaluation tool that checks regulatory functions against a set of more than 260 indicators.” Through its PQM+ and predecessor PQM programs, USAID has been a longstanding partner to NAFDAC. Both programs helped improve NAFDAC’s quality control labs and testing, regulatory inspection, and market surveillance and control. The strengthening of these critical regulatory functions contributed significantly to NAFDAC’s attainment of ML3.
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Uzbekistan Accelerates Medicines Registration Process
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Uzbekistan is celebrating the registration of two WHO-prequalified (PQ) tuberculosis medicines, cycloserine and prothionamide, using the Collaborative Procedure Accelerated Registration (CPAR) process. CPAR fast-tracks registration for medicines that have WHO PQ or are already registered by a stringent regulatory authority. The process improves information sharing between the WHO Prequalification of Medicines Program and national medicines regulatory authorities. It also helps avoid delays in registration, helps medical products reach patients more quickly, and ensures the uninterrupted supply of medicines. In addition, the reduced registration fee should encourage the registration of other WHO PQ medicines in country. PQM+ is also working with Bangladesh to put in place the mechanisms needed to use CPAR there.
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Pakistan’s Public Sector Lab Capable of Testing PPE |
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National quality control labs form the backbone of the regulatory process that detects and prevents substandard and falsified medical products from circulating in country. In Pakistan, PQM+ worked with the Central Drug Laboratory (CDL) in Karachi to equip the lab to conduct post-marketing surveillance testing of medical products, including personal protective equipment (PPE). PQM+ helped procure 11 internationally standardized PPE testing machines, trained CDL staff how to use and maintain the complex machines, and developed and implemented a quality management system. The CDL now hosts a state-of-the-art testing lab that can independently test N95 and KN95 masks, surgical masks, surgical isolation gowns, goggles, face shields, surgical coveralls, and gloves.
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COVID-19 vaccines: PQM+ is collaborating with six countries to strengthen their adverse events following immunization (AEFI) systems. To support the safe deployment of COVID-19 vaccines, PQM+ has assisted Burkina Faso, Ethiopia, Ghana, Kazakhstan, Pakistan, and Uzbekistan to develop procedures, enhance information and adverse event reporting systems, strengthen active surveillance, and generate evidence to support regulatory actions.
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Optimizing financial resources: In Guinea and Kenya, PQM+ is working with national quality control laboratories to establish updated fee-for-service structures. The goal is to ensure adequate financing and help to facilitate the labs’ sustainability. In Guinea, PQM+ trained staff to use a new costing tool to determine realistic testing fees that could help to finance the lab’s operations. In Kenya, PQM+ helped rationalize fees for testing services to help cover the costs of conducting quality testing of antimalarial, reproductive, and maternal and child health products.
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