National medicines regulatory authorities in low- and middle-income countries have had serious difficulties ensuring that the medical products on their markets, or passing through their borders, are safe, effective and of good quality. For example, a 2010 World Health Organization (WHO) review of 26 national medicines regulatory authorities in sub-Saharan found that although most countries had laws for medicines regulation, their capacity was weak, and the regulations did not work together as an effective system.
Weaknesses in pharmaceutical regulatory systems contribute to limited access to safe and effective medicines, including those for malaria; HIV/AIDS; and reproductive, maternal, and childhood diseases.
MTaPS helped low- and middle-income countries improve their pharmaceutical regulatory systems, including pharmacovigilance (PV) systems, to promote transparency and accountability, and to ensure patient safety. Here are a few key achievements:
MTaPS achieved success in helping countries eliminate fake and poor-quality medicines from the market by being a part of the regulatory consultative process. This included making updates to pharmaceutical legislation, policies, and guidelines to ensure medicines are safe and effective.
For example, USAID MTaPS supported the Rwanda Food and Drugs Authority (FDA) in developing its first foundational strategy: the Rwanda FDA Strategic Plan 2021-2024. This plan lays out objectives, strategies, and targets to achieve the FDA’s mission of protecting and promoting public health. MTaPS also supported the development of strategic documents for enforcing regulations and processes for clinical trials, pharmacovigilance (PV), product recalls, and advertisement of regulated medical products. To ensure improvements would sustain over time, MTaPS developed a multi-year pharmacovigilance plan, and trained 55 FDA officials in medical products assessment – a crucial regulatory function.
As a result of MTaPS efforts, Rwanda’s FDA can function fully and is successfully operating on maturity level 3 — “stable, well-functioning and integrated regulatory systems”—according to the WHO Global Benchmarking Tool categorization. Combined, all of MTaPS’ measures have helped remove fake and poor-quality medicines from the market.
To unify processes and guidelines for major regulatory tasks like approving essential medicines, inspecting manufacturers, and tracking drug safety, MTaPS supported countries in strengthening its policies and practices.
For example, across Eastern Africa the MTaPS program promoted a region-driven approach to support local manufacturers in the 11 member countries to better comply with regional and national pharmaceutical regulatory standards and requirements. MTaPS worked to identify gaps and opportunities, reviewed existing policies and regulations, and consulted policymakers and regulators—national medicines regulatory authorities, local pharmaceutical producers and manufacturers, and pharmaceutical distributors and wholesalers.
MTaPS used findings to promote greater regulatory compliance and ways of enabling mutual reciprocity among national medicines regulatory authorities and manufacturers in the region.
For example, MTaPS collaborated with the West African Health Organization (WAHO) of the Economic Community of West African States to launch the first-ever online portal for monitoring and reporting of adverse reactions from medicines and vaccines across WAHO’s 15 member countries. This portal was of particular significance as Africa has a high incidence of hospitalization from adverse drug reactions with its large demand for medicines for HIV, TB, and other diseases.
The pharmacovigilance portal included a regional dashboard that tracked adverse events following immunizations and displays drug safety data reported by each country, informing on treatment options as new regimens enter the market. The portal was part of a wider collaboration between MTaPS, WAHO, and the African Union Development Agency to harmonize medicine regulatory systems on the continent.
