Advancing Regulatory Systems for Improved Access to Safe, Effective, Affordable, and Quality-Assured Medical Products

Many low- and middle-income countries (LMICs) have national regulatory authorities (NRAs) that are responsible for ensuring the safety, efficacy, affordability, and quality of medical products, including medicines, vaccines, medical devices, and other health technologies. However, NRAs face several challenges in fulfilling their core regulatory functions, such as product registration, vigilance, market surveillance and control, licensing, and regulatory inspections.

This technical program update highlights MTaPS’ regulatory systems strengthening approach, which centers on strengthening governance, building institutional and individual capacity, advocating for adequate staffing and financing, promoting regulatory reliance, and increasing the availability and use of information for decision-making in LMICs. MTaPS has supported countries in strengthening their pharmaceutical systems, including improving legal and regulatory frameworks; establishing quality management systems; streamlining product registration, including the use of reliance mechanisms; supporting licensing and regulatory inspections; establishing pharmacovigilance systems; and ensuring regional regulatory harmonization. The program update includes progress, achievements, and key lessons learned from MTaPS’ regulatory systems strengthening work in selected LMICs.