Benin | Burkina Faso | DRC | Ethiopia | Ghana | Guinea | Kenya | Liberia | Madagascar | Mali | Mozambique | Nigeria | Rwanda | Senegal
Bangladesh | Burma | Nepal | Pakistan
Central Asia and Eastern Europe:
Kazakhstan | Serbia | Tajikistan | Uzbekistan
PQM+ collaborates with the Directorate General of Drug Administration (DGDA) to: institutionalize good governance practices to promote greater transparency, accountability, and communication with stakeholders; attain Maturity Level 3, as measured by WHO’s Global Benchmarking Tool, for its market surveillance and control, laboratory testing, lot release, clinical trial, and marketing authorization functions; and implement risk-based post-marketing surveillance. PQM+ helps the National Control Laboratory strengthen its testing capability, especially regarding tuberculosis, family planning, and maternal, newborn, and child health medical products, including vaccines. In addition, the program supports local manufacturers to increase the production of quality-assured first-line anti-TB medicines. PQM+ also supports the country’s COVID-19 vaccination efforts and is helping expand access to quality-assured personal protective equipment (PPE).
Malaria is the leading cause of mortality among children under 5 and the leading cause of morbidity among adults in Benin, according to the U.S. President’s Malaria Initiative (PMI). PMI and its partners support interventions that include large-scale implementation of artemisinin-based combination therapy (ACT) and intermittent preventive treatment for pregnant women. However, the spread of substandard and falsified ACTs could reverse progress and promote the continued emergence and spread of antimicrobial resistance. PQM+ is helping the country’s national quality control laboratory (l'Agence Nationale de Contrôle de la Qualité des Produits de Santé et de l'Eau, ANCQ) strengthen its quality management system to achieve international accreditation, such as ISO/IEC 17025 or WHO prequalification. PQM+ is also working with Benin’s main regulatory body, the Beninois Agency for Pharmaceutical Regulation (l’Agence Béninoise de Régulation Pharmaceutique, ABRP), to establish a national post-marketing surveillance program to help ensure the quality of medical products on the local market.
PQM+ supports the National Pharmaceutical Regulatory Authority (L'Agence Nationale de Régulation Pharmaceutique, ANRP) and National Public Health Laboratory (Laboratoire National de Santé Publique, LNSP) to collaborate and establish a risk-based post-marketing surveillance (RB-PMS) program to monitor malaria medical products circulating in the country. In addition, PQM+ is building the LNSP’s capacity to conduct quality control testing of medical products and gather data to inform regulatory actions on substandard and falsified medicines. PQM+ is also supporting the government’s response to the COVID-19 pandemic.
PQM+ is strengthening the monitoring system of Burma’s Department of Food and Drug Administration (DFDA) to ensure the quality of malaria commodities in circulation. Incorporating international standards in DFDA’s regulatory practices and facilitating a risk-based approach to post-marketing surveillance will help the regulatory body better detect substandard and falsified antimalarials on the market. PQM+ is also building the capacity of DFDA’s pharmaceutical chemistry laboratories in Nay Pyi Taw and Mandalay to maintain or achieve ISO accreditation. Strengthening the lab to assess the quality of malaria commodities, such as long-lasting insecticidal nets, will help DFDA support the country’s malaria control program.
Democratic Republic Of Congo (DRC)
With support from PMI, PQM+ is working with DRC’s national medicines regulatory authority (Autorité Congolaise de Réglementation Pharmaceutique, ACOREP) to help ensure the quality of medical products in country, such as antimalarials, by strengthening its post-marketing surveillance (PMS) function, which includes adopting a risk-based (RB) approach to PMS and establishing a national PMS technical working group. PQM+ will also help ACOREP conduct national RB-PMS of selected medicines to treat malaria. RB-PMS allows governments to channel limited resources to medicines and locations that pose the highest risk to the public.
The Ethiopian Food and Drug Authority (EFDA) registers all medical products; licenses and regulates the production, import, storage, and distribution of transregional medical products; and conducts quality control testing and post-marketing surveillance of medical products circulating in the local market. Regulatory activities that are not mandated to EFDA fall under the jurisdiction of regional government and city administration regulatory bodies. However, the unclear mandates of EFDA and regional regulatory bodies (RRBs), lack of a formal reporting relationship among them, and poor RRB capacity compromise the proper regulatory oversight of medical products.
PQM+ is building the capacity of EFDA and the regional regulatory bodies to monitor the quality of products in the medical product supply chain and strengthen the various bodies’ working relationships to carry out their mandates more efficiently. PQM+ also helps build local manufacturers’ capacity to meet international standards, ensuring that locally produced medical products are of good quality and can help meet country demand. PQM+ is also supporting the government’s response to the COVID-19 pandemic.
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PQM+ is collaborating with the Ghana Food and Drugs Authority (GFDA) to build its capacities to monitor the quality of medical products in country. GFDA is classified as a WHO Maturity Level 3 medicines regulatory authority. With support from the President’s Malaria Initiative (PMI), PQM+ is working with the Ghana Food and Drugs Authority (GFDA) and other stakeholders to adopt a sustainable risk-based approach to post-marketing surveillance and to support local manufacturers, including helping one manufacturer achieve WHO prequalification for antimalarial artemether/lumefantrine tablets and assisting another to produce oxytocin. The program also works with USAID’s Global Health Supply Chain Program to prepare the local pharmaceutical industry and GFDA to adopt GS1 standards, which is a sophisticated track-and-trace system that uses barcodes to capture product information. PQM+ is also supporting the government’s response to the COVID-19 pandemic and is collaborating with Ghana’s FDA to build its capacity to ensure the quality of vaccines.
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To build the country’s quality assurance and control systems and strengthen its health system, PQM+ is helping the National Directorate of Pharmacy and Medicines (DNPM) improve its regulatory functions, namely its registration processes and post-marketing surveillance, focusing on areas and products that have a high risk for public health. The program is also preparing the National Public Health Laboratory (LNSP) for ISO/IEC 17025 accreditation and strengthening its quality testing capacity to inform regulatory actions on substandard and falsified medicines.
Kazakhstan is among the highest multi-drug resistant tuberculosis (MDR-TB) burdened countries in the world. The government is addressing this challenge through its National TB Strategic Plan 2021-2025 and offers universal coverage of TB treatment. In Kazakhstan, most anti-TB medical products are procured locally, often from sources that have not met WHO prequalification standards. Building on the work of its predecessor program, Promoting the Quality of Medicines, PQM+ works closely with Kazakhstan’s national medicines regulatory authority, the National Centre for Expertise of Medicines, Medical Devices, and Medical Equipment (NCEM), to support three regional quality control laboratories to strengthen their quality management systems and capacity to comply with WHO prequalification standards. In January 2020, the World Health Organization recognized the Karaganda MCQL of the NCEM as compliant with the standards of WHO Good Practices for Pharmaceutical Quality and Control Laboratories. The Karaganda MCQL is the first WHO-prequalified laboratory in Central Asia. Two additional laboratories in Nur-Sultan and Almaty are progressing toward WHO prequalification with PQM+ support. PQM+ is also supporting the government’s response to the COVID-19 pandemic.
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PQM+ is collaborating with several stakeholders in Kenya, including the Pharmacy and Poisons Board (PPB), the National Quality Control Laboratory (NQCL), the Division of National Malaria Control Program, and the Health Products and Technologies Department of the Ministry of Health. The program provides assistance to: improve governance for medical product QA systems; strengthen regulatory systems for assuring the quality of medical products; and optimize and increase financial resources for medical product QA systems. This includes increasing the capacity of the NQCL to collect fees for quality control testing of antimalarial and reproductive, maternal, newborn, child, and adolescent health products. In addition, PQM+ works with Kenyan pharmaceutical manufacturers to identify and address challenges related to the local production of essential antimalarial and reproductive, maternal, newborn, child, and adolescent health products in an effort to expand medical product availability and increase revenue.
PQM+ is working with Liberia’s Medicines and Health Products Regulatory Authority (LMHRA) to build its capacity to carry out regulatory functions. PQM+ supported LMHRA to develop its Five-Year Strategic Plan (2021-2025) to strengthen the governance of the medical product quality assurance system. The LMHRA’s board of directors, representing the Ministry of Health, School of Pharmacy, Ministry of Justice, Ministry of Commerce, and the Consumers Groups Association, validated the plan in 2021. In addition, the program is helping draft regulations to strengthen LMHRA’s enforcement actions and the registration and importation of medicines, as well as improve the national quality control laboratory’s ability to undertake post-marketing surveillance to monitor the quality of medical products in circulation and boost its own revenue stream.
The Government of Madagascar is addressing several pressing health issues, including high levels of malaria, child and maternal mortality, and an unmet need for family planning products. PQM+ is assisting the National Medicines Regulatory Authority (Direction de l’Agence du Médicament de Madagascar, DAMM) to strengthen the capacity of the NCQL and systems for PMS of medicines in the country. In addition, PQM+ is working to improve the national pharmacovigilance monitoring system, particularly regarding medical products used in the national malaria, maternal and child health, and family planning and reproductive health programs.
The Government of Mali has engaged in widespread institutional reform over the past decade. However, the country has no national pharmaceutical regulatory agency, and its medicines regulatory system remains fragmented. PQM+ is strengthening Mali’s regulatory system by building the capacity of the Directorate of Pharmacy and Medicines (DPM) to carry out important functions, including risk-based post-marketing surveillance. PQM+ is also improving the coordination of PMS activities by supporting a technical working group to plan and oversee the PMS of antimalarial and maternal and child health medicines and to build capacity of DPM’s dossier evaluation committee to evaluate Common Technical Documents (CTDs). The program supports the National Health Laboratory (Laboratoire National de la Santé, LNS) to achieve ISO/IEC 17025 accreditation and establish a metrology team.
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Mozambique established its National Pharmacy Directorate (Direcção Nacional de Farmácia, DNF) in 2017. PQM+ is working with DNF to build and strengthen its core regulatory functions, systems, and processes. This includes improving its regulatory and organizational capacity to comply with international standards for pharmaceutical and other medical products regulatory agencies. PQM assisted Mozambique’s national quality control laboratory (now the Department of Drug Quality Check, DCQ) in carrying out medicines quality testing to identify substandard and falsified medicines in the local market. However, limited government funding and insufficient human resources have hindered the laboratory’s ability to sustainably perform these functions. PQM+ is working with the DNF and DCQ to develop key medicines regulations, helping the DCQ improve its quality management system and attain ISO 17025:2017 accreditation, and build the DNF’s capacity to carry out its regulatory functions and develop sustainability plans for DCQ operations.
PQM+ is working with Nepal’s Department of Drug Administration (DDA) to strengthen its medical product quality assurance (QA) and quality control (QC) systems at the federal and subnational levels. In addition, PQM+ and DDA are collaborating with the National Medicines Laboratory (NML) to enhance medical product regulatory functions and strengthen the NML to meet international standards. PQM+ also works with the National Health Research Council, Logistics Management Section, Association of Pharmaceutical Producers of Nepal, and other public and private sector stakeholders to improve access to quality medicines and to prevent, detect, and respond to the proliferation of substandard and falsified medicines.
A major challenge affecting Nigeria’s health system is the lack of available quality-assured essential medical products. PQM+ is helping ensure the quality of medicines and other medical products in Nigeria with an emphasis on USAID and Government of Nigeria priority malaria and maternal and child health medicines and family planning commodities.
PQM+ works in collaboration with the government, public agencies, and private sector actors to institute interventions that will improve Nigeria’s manufacturing capabilities, ensure strong national and subnational regulatory systems, and improve the quality of medicines at last-mile points of care, such as community pharmacies and proprietary patent medicine vendors. PQM+ supports the increased registration of medicines retail outlets with the Pharmacists Council of Nigeria (PCN) and increased inspections of these outlets for medicines surveillance and quality improvement and to ensure product quality, safety, and efficacy. PQM+ also is strengthening quality management systems and building laboratory capacity in quality control testing in compliance with international standards to help ensure the quality of medical products circulating in country.
PQM+ builds on the successes of its predecessor, USAID’s Promoting the Quality of Medicines (PQM) (2012–2019) in Nigeria. PQM+’s key activities included providing technical support for:
- Enhanced quality management systems in the National Agency for Food and Drug Administration and Control (NAFDAC), National Institute for Pharmaceutical Research and Development, and several local pharmaceutical manufacturers;
- Attainment of International Organization for Standardization (ISO)/International Electrotechnical Commission (IEC) 17025 accreditation of NAFDAC’s four laboratories and the National Institute for Pharmaceutical Research and Development (NIPRD) central laboratory at Abuja;
- Implementation of medicines post-marketing surveillance; and
- Development of a Good Manufacturing Practice roadmap and National Quality Assurance Policy document.
Pakistan’s regulatory system has limited capacity for medicines quality surveillance, which contributes to the proliferation of substandard and falsified medical products in the country. The lack of regulatory enforcement and centers to conduct reliable bioequivalence studies reduces confidence in the efficacy of generic medical products manufactured in Pakistan. Inconsistent government policies for the pharmaceutical sector have undermined the private sector’s potential role in improving health outcomes. PQM+ focuses on advancing medicine quality assurance elements to enhance Global Health Security Agenda initiatives; promoting maternal, newborn, and child health; addressing communicable diseases; and engaging the private sector in achieving better health outcomes and contributing to economic development.
PQM+ is also supporting the government’s response to COVID-19 through several activities, including facilitating emergency use authorization for vaccines, supporting the local manufacture of personal protective equipment, engaging the private sector to build the capacity of public and private sector diagnostic laboratories to use new COVID-19 diagnostic technologies, and building the capacity of hospital staff to manufacture alcohol-based hand sanitizer in-house, which helps optimize resources.
Read the impact stories:
- Pakistan builds private partnerships to improve vaccine safety and surveillance
- Strengthening Pakistan’s public diagnostic labs to respond to COVID-19
- Improving access to COVID-19 treatment through technology transfer
- Pakistan begins to manufacture, export quality-assured PPE to fight COVID-19
- Pakistan establishes first public sector lab to test quality of PPE
- Stronger medical product quality assurance systems respond during COVID-19
PQM+ is working with the Rwanda Food and Drug Authority (FDA) to strengthen its medicines regulatory systems and health workforce. The program is supporting the FDA’s National Quality Control Laboratory toward achieving ISO 17025:2017 accreditation and/or WHO prequalification. PQM+ is also helping the FDA conduct regular risk-based PMS activities for family planning/reproductive health and maternal, newborn, and child health products to reduce the prevalence of substandard or falsified products in the market. PQM+ coordinates with local manufacturers to verify that they follow Good Manufacturing Practices to ensure the production of quality-assured essential health commodities. In addition, PQM+ collaborates with the Rwanda Medical Supply Limited to implement good procurement, storage, and distribution practices. The program also supports the University of Rwanda School of Medicine and Pharmacy’s efforts to sustainably develop a competent regulatory workforce to meet the country’s needs.
The Government of Senegal seeks to build an efficient system of regulation and control to ensure the quality of medicines in the country. It developed a five-year (2019–2023) integrated strategic plan for the Directorate for Pharmacy and Medicines (DPM) and the National Medicines Control Laboratory (Laboratoire National de Contrôle des Medicament, LNCM). The strategic plan highlights areas within both DPM and LNCM that need strengthening, including financing, human resources, and information systems. To strengthen DPM and LNCM, PQM+ facilitated the establishment of a national PMS unit that includes DPM, LNCM, and a range of stakeholders, as well as strengthening LNCM’s capacity to ensure the quality of medicines and eventually achieve ISO accreditation and WHO prequalification. The program is supporting Senegal to conduct risk-based PMS (RB-PMS) to gather data that will inform regulatory decisions around substandard and falsified medical products in the country.
PQM+ supported the Government of Serbia’s response to the COVID-19 pandemic by assisting the Institute for the Application of Nuclear Energy (INEP) at the University of Belgrade with third-party performance validation/evaluation of the institute’s enzyme-linked immunosorbent assay (ELISA) COVID-19 test and implementing a market demand/competitiveness assessment of the ELISA kit. These activities were completed in 2022.
Tuberculosis (TB) continues to be a significant public health threat in the Republic of Tajikistan, including multi-drug resistant tuberculosis (MDR-TB). The National TB Program, through its National Strategic Plan for TB 2021–2025, focuses on various interventions, including ensuring universal access to quality treatment and care. A key pillar for reducing morbidity and mortality is the availability of safe and quality-assured medicines for effective treatment.
Since 2018, Tajikistan has transitioned from support by The Global Fund to Fight AIDS, Tuberculosis, and Malaria (Global Fund) to the domestic procurement of first-line anti-TB drugs. Tajikistan does not currently have a WHO PQ-approved medicines quality control laboratory (MQCL) that can test the quality of drugs according to international standards. PQM+ is supporting the Medicines Regulatory Authority to strengthen its medicines registration system. The program is also working with the MQCL to strengthen its quality management system and to improve its compliance with international standards to deliver reliable and accurate results from medical products quality testing activities.
Uzbekistan is transitioning from Global Fund-supported procurement of TB medicines to domestically funded and produced quality-assured TB medicines. To help the government strengthen the local production of quality-assured medicines in the country, PQM+ is working with the Agency for Development of the Pharmaceutical Industry to improve the medicine regulatory system. This work includes improving medicine review and registration, supporting medicine quality control laboratories in reliably and accurately testing the quality of medicines, and preparing the Good Manufacturing Practices inspectorate for accession to the Pharmaceutical Inspections Cooperation Scheme (PIC/S). PQM+ also provides technical assistance to pharmaceutical manufacturers to boost the supply of locally manufactured, quality-assured TB medicines.
PQM+ is supporting the government’s response to the COVID-19 pandemic by collaborating with the Agency for the Development of the Pharmaceutical Industry, including the State Center on Expertise and Standardization of Medicines, Medical Equipment, and Medical Devices to develop a system for emergency use authorization and monitor the quality of vaccines in country.
Read the impact stories from PQM+, USAID, and USAID Central Asia.