How to Regulate Health Products Efficiently, Increase Access, and Save Lives? Take a Regional Approach

 Every public health emergency - whether it is an outbreak of measles, polio, or Ebola - requires a country’s health system to respond rapidly. During a time when COVID-19 continues to increase morbidity and mortality, disrupt economic growth, and weaken supply chains, investments are needed to strengthen health systems while maintaining equitable access to quality, essential services, and medical products. The pandemic has made it more evident that the world's response is only as strong as its weakest link. National Medical Regulatory Authorities (NMRAs) are one of the key actors in the rapid and efficient response to a pandemic as they are responsible for ensuring the quality, safety, and efficacy of medical products (i.e., diagnostics and other devices, vaccines, and drugs). These medical products are considered global public goods because everyone benefits from their ability to prevent, treat, and slow the spread of disease. Therefore, it is critical to strengthen NMRAs of low- and middle-income countries (LMICs) in order to ensure access to such global public goods.

The NMRA in the United States, the Food and Drug Administration, has the capacity to efficiently review medical products; authorize and register them for the market; and increase timely access to quality-assured, safe, effective, life-saving products for millions of Americans. However, this is not the case for most NMRAs in LMICs, which are often under-resourced and overwhelmed with competing and urgent issues, including ensuring access to products to help prevent maternal and child deaths, combat infectious diseases, and other public health challenges. 

The WHO Global Benchmarking Tool (GBT) process is used to objectively evaluate the maturity of a country’s regulatory system for health commodities, identify gaps, and develop concrete plans to prioritize and coordinate support. A 2018 mapping of the GBT evaluations showed  that approximately 50 percent of countries “lacked legal provisions to permit emergency-prone product registration procedures”. For more than 30 years, USAID has partnered with LMICs to achieve a higher maturity level by taking a holistic approach to regulatory system strengthening (RSS). USAID’s Medicines, Technologies, and Pharmaceutical Services (MTaPS) and Promoting the Quality of Medicines Plus (PQM+) programs are exploring ways to increase efficiencies by implementing regional development approaches for RSS, specifically related to market authorization, market surveillance, and strengthening capacity across each of the nine core regulatory functionsUSAID’s technical assistance includes strengthening regulatory systems across each of the nine WHO GBT components: 1) the national regulatory system (policies, laws, etc.), 2) registration and market authorization, 3)pharmacovigilance/safety monitoring, 4) market surveillance and control of quality, 5) licensing, 6)  inspection,  7) laboratory testing for quality, 8) clinical trial oversight, and 9) lot release..

USAID’s partnership with regional institutions and networks, such as the Association of Southeast Asian Nations (ASEAN), the Southeast Asian Regulatory Network (SEARN), and the African Medicines Regulatory Harmonization Initiative (AMRH), aim to improve collaboration among NMRAs and support them to converge technical standards and guidelines for medicines registration and adopt international and regionally-endorsed standards. USAID has long supported regulatory harmonization through regional economic communities and platforms, and looks forward to exploring opportunities to support the new African Medicines Agency to promote RSS across the Africa region. USAID facilitates regional workshops that support NMRAs to cooperate and jointly conduct advanced assessments of products, such as vaccines and biologics, as well as implement common technical registration protocols that are modeled after more advanced NMRAs. These approaches reduce the time it takes to register products, reduce barriers to trade, and ensure quality medical products are brought to market quickly. 

Additionally, USAID supports countries to implement WHO’s collaborative registration procedure, which is a faster pathway for registering WHO prequalified medicines. In Central Asia, USAID technical assistance improves information sharing, eliminates duplicative regulatory work, and accelerates in-country registration of quality-assured tuberculosis products. To support NMRAs as they manage ongoing submission and safety monitoring processes during the current pandemic, USAID also developed two new guidance documents on adopting, implementing, and managing expedited approval pathways for COVID-19 vaccines and diagnostics. 

Another efficiency in RSS includes harmonizing regulatory information management systems (RIMS). USAID’s support for developing minimum, global and/or regional standards and operating requirements for RIMS aims to increase interoperability and therefore communications across the national, regional, and global information systems. The electronic transmission of standardized data will help NMRAs streamline workflows and rapidly respond to quality and safety issues of medical products across markets. 

USAID also works with regional institutions to strengthen local capacity, such as the Center for Regulatory Excellence in Singapore (CoRE), to train NMRA personnel and improve their competencies. As the demand for medical products increases, USAID is working with SEARN to train regulators and pharmaceutical manufacturer staff on current Good Manufacturing Practices to increase compliance to regulatory standards for inspections. 

RSS development approaches should facilitate regional collaboration to increase shared technical expertise, support the adoption of regional and international standards, reduce inefficiencies, and strengthen human resources and institutional capacity. By supporting mutual reliance on decisions made by NMRAs in the region, countries will increasingly trust each other’s capabilities and learn from each other while advancing together. 

The views in this article are those of the authors and do not necessarily represent the views of USAID nor the United States Government.