Strengthening Regulatory Systems To Improve Medical Product Quality in Low- and Middle-Income Countries. September 2018
(2018; 29 pages)

Kaddu G, D’Amore E, Clark A, Nkansah P. Strengthening Regulatory Systems To Improve Medical Product Quality in Low- and Middle-Income Countries. 2018. Promoting the Quality of Medicines (PQM) program. U.S. Pharmacopeial Convention. Rockville, Maryland.


Progress against the world’s most pressing global health threats—including malaria, tuberculosis, and HIV/AIDS—requires broad and concerted efforts to strengthen systems that help ensure uninterrupted access to safe and effective health services, medicines, and supplies. Availability of and access to essential medicines underpins progress against these diseases; however, it is only when these medi¬cines are produced, distributed, and sold in a manner that ensures their quality that they can bring about positive outcomes for patients and public health.

A strong medicines regulatory system is an essential component of the health system that helps protect populations by ensuring that medicines and other medical products are not only safe and effective but also of assured quality. Poor-quality medicines—those that are unregistered, substan¬dard, or falsified—can endanger patients, extend illness unnecessarily, and even result in death. Poor-quality medicines also undermine efforts to improve health and strengthen health systems, erode public confidence in those same systems, and may contribute to antimicrobial resistance.

In most countries, a medicines regulatory authority (MRA) is responsible for providing regulatory oversight of all medical products (medicines, vaccines, biological and blood products, traditional or herbal medicines, and medical devices). The regulatory authority oversees several key functions, including product registration; control of medicine importing and exporting; inspections of manufacturers, distributors, importers, wholesalers, and retailers; post-marketing surveillance; and control of pharmaceutical promotion and advertising.

In low- and middle-income countries (LMICs), MRAs often have limited capacity and insufficient resources to carry out these critical regulatory functions, which can mean delays in getting medicines to those who need them most, and when medicines are available, their safety and quality may not be fully assured.

This document reviews key regulatory challenges in LMICs, the key areas in which PQM aims to build or strengthen regulatory capacity, and shares lessons learned from the program’s extensive implementation experience. Strengthening the capacity of MRAs requires in-depth and ongoing consideration of the broader country context and health system components that interact and influ¬ence MRA operations. As such, PQM relies on strategies and interventions rooted in systems thinking to sustainably strengthen regulatory capacity.

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