Funded by the U.S. Agency for International Development and implemented by the U.S. Pharmacopeial Convention (USP) and its consortium of partners, the PQM+ program (2019-2024) sustainably strengthens medical product quality assurance systems in low- and middle-income countries (LMICs). Medical product regulatory systems, which include quality assurance systems, are complex and dynamic, and have direct impacts on public health. Their ability to ensure the quality, safety, and efficacy of products on the market underpins the success of USAID’s global health programs.
PQM+ provides technical assistance to national medicines regulatory authorities (MRAs) and local manufacturers of priority medical products to expand the supply and improve the quality of essential medical products used to prevent and treat COVID-19, malaria, neglected tropical diseases, and tuberculosis and to improve maternal, newborn, and child health. The program collaborates with countries to develop and implement tailored strategies that optimize limited health resources, promote equity, ensure the quality of medical products, and enhance the sustainability and resilience of their health systems.
PQM+ builds on the legacy of USAID’s PQM program, which between 2009 and 2020 improved quality assurance systems in more than 40 countries, including strengthening more than 90 national quality control laboratories (NQCLs) in 33 countries. PQM also built the capacity of 45 manufacturers in 12 countries to produce quality essential medicines.
Strengthen regulatory systems
A regulatory system consists of all organizations, people, and actions whose primary intent is to ensure access to essential medicines and other health products of assured quality, safety, and efficacy or performance. The result is many points of vulnerability – such as during storage and distribution – as well as many opportunities to strengthen the system. To improve national regulatory systems in LMICs, PQM+ partners with a wide range of stakeholders - regional and national MRAs, NQCLs, academic institutions, and other international organizations. Together, we develop tailored strategies and increase local capacity to carry out key quality assurance functions, including product registration, inspections of medical product manufacturers and distributors, and post-marketing surveillance of medical products.
Build national drug quality control laboratory (NQCL) capacity
NQCLs play an essential role in helping MRAs to control the quality of medical products in circulation. They are mandated to generate quality data for regulatory decision-making. Health programs, including those for tuberculosis, maternal and child health, malaria, and other infectious diseases, rely on access to quality medical products. Pharmaceutical supply chains in LMICs are vulnerable to the introduction and proliferation of substandard and falsified (SF) medical products, including those used to prevent and treat COVID-19.
However, many LMICs lack effective NQCLs capable of carrying out critical regulatory functions, such as continuously testing medical products and providing reliable data to MRAs. MRAs use that information to make timely decisions about authorizing new medical products and to take actions to ensure the safety of medical products already in the supply chain. By helping to detect SF medical products and remove them from circulation, NQCLs can help to save lives.
PQM+ works with NQCLs to help build their capacity to accurately and reliably test the quality of medicines according to international standards, required for ISO/IEC 17025:2017 accreditation and the WHO prequalification program. In January 2020, WHO prequalified Kazakhstan’s Karaganda NQCL, making it the first in Central Asia to achieve that distinction. Two additional laboratories in Nur-Sultan and Almaty are also progressing toward WHO prequalification. Bangladesh’s National Control Laboratory became the country’s first laboratory to earn WHO prequalification in March 2020.
Support local manufacturing of quality medical products
The PQM+ program identifies and supports local and international manufacturers to produce priority medical products that meet internationally recognized standards and comply with Good Manufacturing Practice (GMP). These products include personal protective equipment (PPE), which is used to prevent the spread of infectious diseases, such as COVID-19. Compliance with GMP is required to market medicines in countries with stringent regulatory standards, for participation in the WHO prequalification program, and to ensure that only quality-assured medicines are used in health programs.
Achieving WHO prequalification or local authorization is a long process with many intermediary steps and milestones. PQM+’s work with manufacturers includes: conducting detailed assessments of their ability to manufacture a medicine to achieve prequalification; supporting product and dossier development; developing and implementing a corrective and prevention action (CAPA) plan to address GMP gaps; helping compile and submit product dossiers; conducting mock audits; and addressing and resolving CAPAs from the official WHO audit.
Medical product regulatory systems not only enable patient access to quality-assured medical products but also prevent the proliferation of unsafe products. To promote the sustainability of these systems, PQM+ implements strategies to improve their governance, financial resources, and health workforces.
PQM+ collaborates with governments to develop appropriate policies, laws, guidance and regulations to assure the quality of medical products circulating in their markets and protect the public’s health. The program also works with stakeholders to establish multisectoral groups, including technical working groups, to advance medical product quality assurance in their countries.
To promote the long-term sustainability of financing for regulatory activities, PQM+ works with countries to implement risk-based approaches, such as risk-based post-marketing surveillance and risk-based inspection. These approaches channel limited resources toward products and locations with the highest risks to patients, maximizing the likelihood that higher-risk medical products will be identified and regulatory actions taken to protect patient safety.
A strong workforce is essential to the long-term sustainability of medical product regulatory authorities. To help ensure regulatory authorities are staffed with an appropriate number of professionals with the right skill mix and competencies to make evidence-based regulatory decisions, the program strengthens local and regional workforce capacity. This includes supporting academic institutions to increase the number of qualified professionals entering fields relevant to quality assurance and manufacturing.
Advance USAID health goals
The COVID-19 pandemic has underlined the critical role that medical product regulatory systems play in protecting global health. Access to quality-assured medical products is essential not only to protect citizens from emerging health threats, but also to ensure the ongoing success of national health programs and to protect hard-won gains. By helping to increase the supply of quality-assured medical products, PQM+ is supporting USAID and country health programs to prevent and treat diseases such as malaria, neglected tropical diseases (NTDs), tuberculosis, COVID-19 and other infectious diseases as well as to improve maternal, newborn, and child health.
As part of the U.S. government’s Initiative for Global Vaccine Access, also known as Global VAX, USAID obligated $7.1 million to the PQM+ program. PQM+ will strengthen regulatory and/or manufacturing capacity in six African countries, including Ghana, Kenya, Nigeria, Rwanda, Senegal, and South Africa, to expand access to COVID-19 vaccines. The program works in concert with national stakeholders, such as regulatory authorities and local USAID missions to develop tailored assistance to achieve country-specific goals.