Support to Local Manufacturers Helps Expand Supply of Quality-Assured Medical Products
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Over the past year, PQM+ has helped local pharmaceutical manufacturers in Africa and Asia work toward international prequalification (PQ) or local market authorizations for 52 medical products, especially essential medicines for maternal, newborn, and child health (MNCH), as well as for tuberculosis (TB) and neglected tropical diseases (NTDs). PQ from the World Health Organization (WHO) will signal that these medical products meet international standards for quality and can be used or procured with confidence. Similarly, the CE Mark ensures that medical products meet European standards for quality.
In particular, the PQM+ team worked with manufacturers to adopt good manufacturing practices (GMP), which are critical to ensuring a medical product is quality-assured and fit for its intended use, protecting the public from substandard products. PQM+ offers a free eLearning course, Foundations of Good Manufacturing Practices. The program also supported the production of quality-assured COVID-19 medical products, specifically remdesivir in Pakistan and personal protective equipment in both Bangladesh and Pakistan.
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Webinar Explains How Stronger Regulatory Systems Can Position Countries to Better Respond to COVID-19 |
Recently, PQM+ kicked off a two-part webinar series called “Playing the Long Game: How Can Strengthening Medical Product Regulatory and Manufacturing Systems Help Countries Respond to COVID-19 and Future Health Crises?” In the first webinar, experts discussed how countries can pivot and implement new regulatory tactics, including emergency use authorization (EUA), to ensure the quality of medical products, particularly during the in-country distribution of COVID-19 products, such as vaccines. Mr. Khalid Mahmood, program management specialist for USAID/Pakistan, provided an introduction. To unpack these regulatory approaches, speakers highlighted activities from Bangladesh, Burkina Faso, Ghana, Mali, and Pakistan. The second webinar in the series, “Silver Linings Amidst COVID-19: Tapping Into – and Building – the Pharmaceutical Industry in Low- and Middle-Income Countries,” will occur in early 2022.
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Improving Cost-Efficiency of Medicines Quality Testing |
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PQM+ is supporting government agencies to revamp or establish fee structures for medicines quality testing services to improve the financial sustainability of their laboratories. Kenya is one country where PQM+ is assisting the National Quality Control Laboratory (NQCL) to optimize resources by analyzing the costs and fees of its testing services. PQM+ is advising on measures to ensure the financial sustainability of NQCL activities.
Similar work is ongoing in Bangladesh, Ethiopia, Liberia, and Mali, where PQM+ supported government agencies to revamp or establish fee structures for medicines quality testing services to increase the financial sustainability of their laboratories. PQM+ advised officials in Mali on how to apply a new financial model to determine more accurate costs of quality control tests, weighing expenses related to factors such as equipment calibration, preventive maintenance, reaccreditation fees, and continuous professional development for technical personnel.
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Bangladesh Acts on WHO Recommendations from Global Benchmarking Tool Assessment |
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PQM+ worked with the Directorate General of Drug Administration (DGDA), the medical regulatory authority in Bangladesh, to respond to recommendations from the World Health Organization's Global Benchmarking Tool (GBT) assessment. The GBT identifies gaps and weaknesses in a country’s regulatory system. PQM+ helped address 206 of the 274 recommendations, moving the regulatory authority further toward GBT Maturity Level 3 status. PQM+ staff also observed the assessment program and helped the DGDA develop a corrective and preventive actions plan.
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To protect the public's health in Nepal and build awareness about the risks of substandard and falsified (SF) medical products, the country’s Department of Drug Administration (DDA) and PQM+ collaborated to design informational posters. The posters outline how to identify quality-assured medical products and avoid SF ones. The DDA and PQM+ produced 5,000 posters to display in retail pharmacies in major cities across the country. The DDA distributed the posters through networks of professional bodies such as the Nepal Chemist and Druggist Association, Pharmacy Society of Nepal and Nepal Pharmaceutical Association.
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USAID representatives visited Andijan, Uzbekistan, this fall for a ceremonial handover of high-performance liquid chromatography (HPLC) medical product testing equipment. PQM+ helped procure this important laboratory tool for the Andijan Medicines Quality Control Laboratory. Cherry Gumapas, Health Development Office Director for USAID’s Uzbekistan Mission, said, “This event highlights our shared commitment to upgrade the quality of Uzbekistan’s medical products to meet required international standards established by the World Health Organization’s prequalification process. Access to medical products tested under Good Laboratory Practice standards is an important objective of the Government of Uzbekistan.”
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PQM+ is supporting five countries - Ethiopia, Kenya, Nepal, Nigeria and Pakistan - to develop strategies to grow their pharmaceutical sectors. The program worked with country counterparts to solicit information on constraints to pharmaceutical production experienced by local manufacturers. PQM+ also helped to form high-level working groups composed of public and private sector membership to collaborate on drafting long-term strategies.
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Expanding Africa's Capacity to Manufacture Medical Products for Neglected Tropical Diseases (NTDs) |
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To strengthen the capacity of African manufacturers of medical products for NTDs, PQM+ is inviting manufacturers to submit an expression of interest (EOI) application for evaluation to receive technical support toward WHO PQ for quality-assured medicines. This will help increase access to affordable, quality-assured treatments for NTDs. This EOI is designed for manufacturers of eight NTD products, such as ivermectin 3 mg tablet. Successful applications will receive technical assistance from PQM+ to complete their application for WHO PQ. PQM+ will consider funding 50 percent of the cost for relevant in vivo bioequivalence studies.
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