Eliminating Poor-Quality Medicines through an Effective Regulatory System in Rwanda

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View the original story on the Medicines, Technologies, and Pharmaceutical Services (MTaPS) Program website.

Roughly 18.7% of essential medicines circulating on the market in Africa are substandard and falsified, which hamper effective treatment. The prevalence of poor-quality medicines on the market is a direct result of a country’s weak regulatory system that is unable to detect and prevent their use. Rwanda established the Food and Drugs Authority (FDA) in 2018 with a mandate to protect public health by regulating human and veterinary medicines, vaccines, medical devices, foods, and cosmetics. However, the FDA’s operationalization is still at a nascent stage, with lack of a plan, guidance on processes, and the capacity needed for implementation.

The USAID MTaPS Program supported the Rwanda FDA to strengthen its regulatory functions that underpin effective, safe, and quality-assured health products and enhance patient safety for better treatment outcomes.

Establishing a Strong Pharmaceuticals Regulatory System

Developing a Regulatory Framework

MTaPS program supported the FDA in developing its first foundational document through a consultative process. The Rwanda FDA Strategic Plan 2021-2024 lays out objectives, strategies, and targets to achieve the FDA’s mission of protecting and promoting public health. MTaPS also facilitated the validation of key documents for the quality management system through stakeholder workshops, which provide a framework for enforcing regulations and processes for clinical trials, pharmacovigilance (PV), product recalls, and advertisement of regulated medical products. An additional 12 documents were validated to provide guidance on processes, including for registration of medical products, issuance of import and export permits, and assessment of adverse drug reactions. Diverse stakeholders, such as research and teaching institutions, food industries, media, and consumers, were invited in the validation process. To bolster the functioning of Rwanda FDA’s PV division—a critical role of the regulatory system to ensure drug safety—MTaPS helped develop a multiyear national PV plan that defined key responsibilities and a strategic framework for planning, implementation, and monitoring of PV activities.

Building National Regulatory Capacity

MTaPS trained 55 FDA officials in medical products dossier assessment – a crucial regulatory function. The program also organized a Drug and Therapeutics Committee training to build the PV capacity of new FDA personnel, doctors, nurses, and pharmacists from public and private health facilities.

Ensuring Medical Products are Safe, Effective, and Quality Assured

The MTaPS program’s assistance is enabling Rwanda FDA to function fully and elevating it to maturity level 3—“stable, well-functioning and integrated regulatory systems”—according to the WHO Global Benchmarking Tool categorization. Further, the validation of the quality management system documents advances FDA toward ISO 9001:2015 certification – the international standard for safety, efficacy, and quality of medicines and medical products. These measures will help remove falsified and substandard medicines from the market and contribute to improved treatment outcomes and greater confidence of people in the health system.

“The strategic documents are key for FDA’s operationalization and to achieve FDA’s mission of promoting and protecting public health. They will promote quality, productivity, and transparency of FDA’s activities.” – Dr. Charles Karanga, Director General, Rwanda FDA

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