Uzbekistan’s ‘Quality Club’ Boosts Collaboration to Improve Access to Quality-Assured Medicines
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Uzbekistan’s overall incidence of tuberculosis (TB) and the mortality associated with it have decreased, but the country ranks among the top 20 for rates of multi-drug resistant tuberculosis (MDR-TB). Cases of extensively drug-resistant tuberculosis (XDR-TB) have also emerged, according to the World Health Organization.
Uninterrupted access to quality-assured medicines is critical to treating and controlling TB. To help achieve that goal, Uzbekistan has launched the Quality Club, a pioneering effort to strengthen the local production of quality-assured medicines, including those for TB. The Quality Club will promote engagement and dialogue between the local pharmaceutical industry and the Agency for the Development of Pharmaceutical Industry under the Ministry of Health.
“Development of a strong domestic pharmaceutical industry that can produce high-quality standards medicines, including TB medicines, is important from a public health as well as an economic development standpoint,” said Cherry Gumapas, Health Development Office Director for USAID/Uzbekistan.
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Expanded Manufacturing of Medicines Helps #BeatNTDs |
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To tackle neglected tropical diseases (NTDs), USAID is expanding the global supply of quality-assured NTD medicines. Through the Promoting the Quality of Medicines Plus (PQM+) program and predecessor PQM program, USAID has supported four Asia-based manufacturers to achieve WHO prequalification: three for the active pharmaceutical ingredient for praziquantel and one for the finished product. Praziquantel is used to prevent and treat the parasitic worm infection schistosomiasis. This technical support is a multi-year process, involving meeting with interested manufacturers, reviewing their manufacturing processes, and working collaboratively to meet standards of quality, safety, and efficacy. Diversifying the source for this medicine will benefit millions.
Read more about USAID's work to beat NTDs in this recent blog.
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New Guidance to Accelerate Emergency Use Authorization |
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National regulatory authorities (NRAs) worldwide have turned to emergency use authorizations (EUAs) to accelerate the availability of COVID-19 vaccines and diagnostic devices based on quality, safety, efficacy, and performance data. However, the procedures used by regulatory authorities vary widely. To support NRAs in managing ongoing authorization and safety monitoring processes, PQM+ developed two guidance documents with practical instructions for adopting, implementing, and managing expedited approval pathways. One focuses on vaccines and the other on diagnostics.
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Risk-based post-marketing surveillance (RB-PMS) channels limited resources for post-marketing quality surveillance toward medicines and locations that present the highest risks to patients. This approach lowers the cost of assessing the quality of medicines in the market. PQM+ supports RB-PMS of a variety of medical products in multiple countries.
● Antimalarials - Benin, Burkina Faso, Democratic Republic of Congo, Ethiopia, Ghana, Guinea, Kenya, Liberia, Madagascar, Mali, Nigeria, and Senegal
● Family planning/reproductive health - Bangladesh, Ethiopia, Madagascar, Nepal, and Rwanda
● HIV and AIDS - Mozambique
● Maternal and child health - Bangladesh, Ethiopia, Ghana, Guinea, Kenya, Liberia, Madagascar, Mali, Nepal, Nigeria, and Rwanda
●Tuberculosis - Bangladesh, Kazakhstan, and Uzbekistan
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PQM+ is also collaborating with countries to build their capacity to manufacture quality-assured medical products locally, including those used to treat and prevent COVID-19.
● PQM+ supported Ethiopia and Kenya in their progress toward compliance with Good Manufacturing Practices (GMP). In Kenya, we helped strengthen the ability of the Pharmacy and Poisons Board to conduct regulatory oversight and promote GMP compliance by local manufacturers of medicines to treat malaria, maternal and child health conditions, and reproductive health and family planning concerns, among other medical products. PQM+ joined the Ethiopian Food and Drug Authority-led Regulatory Capacity Building Technical Team for Local Pharmaceutical Industries and is helping develop implementation steps for existing GMP guidelines and the Pharmaceutical Establishment Directive.
● Our team conducted a fully remote GMP inspection of a manufacturer in Bangladesh that produces a four-drug fixed-dose combination (4FDC) TB medicine. The program used a remote inspection tool to assess the manufacturer’s compliance with GMP.
● PQM+ supported Pakistani manufacturer Ferozsons to produce remdesivir (under the brand name Remidia) for use in country as well as for export. Pakistan has expanded its exports of the drug to 16 nations: Angola, Aruba, Belarus, Dominican Republic, Honduras, Indonesia, Jamaica, Kenya, Libya, Mozambique, Philippines, St. Maarten, Tanzania, Uganda, Ukraine, and Uzbekistan.
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Lab testing is critical to assess the quality of medical products. In Nepal, PQM+ is working with the National Medicines Laboratory’s technical staff to build their quality assurance and quality control knowledge. Recently, NML staff learned about good weighing practices, mechanical calibration, performance verification test of dissolution, good documentation practices, and high-performance liquid chromatography, among other areas.
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USAID’s ongoing investments in health systems strengthening are positioning countries to better respond to the COVID-19 pandemic. PQM+ is coordinating closely with several countries to boost the quality of their medical products, as captured by two recent Marketlinks blogs on manufacturing and regulation.
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As part of the Prince Mahidol Award Conference, PQM+ convened a panel of experts to discuss strategies to help national regulatory authorities prepare for emerging infectious disease pandemics. The panel discussed risk-based approaches and adoption of national expedited regulatory approval procedures that use regional and global reliance to speed access to medical products while ensuring sufficient quality, safety, and efficacy. Watch the panel discussion here.
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Our next webinar, “Playing the Long Game: Strengthening Medical Product Regulatory and Manufacturing Systems to Help Countries Respond to COVID-19 and Future Health Crises,” will take place later this spring. Stay tuned!
As we start our third year, PQM+ is working with 21 low- and middle-income countries to sustainably strengthen their medical product quality assurance systems. Learn more about our progress in our second annual report.
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