Ghana has strengthened its medicines regulatory system to ensure safety, quality and effectiveness of medical products manufactured, imported or distributed within the country, the World Health Organization (WHO) announced today.

Ghana becomes the second country in the WHO African Region to attain regulatory system “Maturity Level 3” – the second-highest in the four-tiered WHO classification of national medicines regulatory systems. Evaluations of Ghana Food and Drugs Authority – the national regulatory body for medicines – were carried out in 2014, 2015 and 2019 through the WHO Global Benchmarking Tool.

“This is a milestone achievement. Strong national regulatory systems are critically important to ensure that when people seek treatment they receive effective medication and are safe from harm,” said Dr Matshidiso Moeti, WHO Regional Director for Africa. “Access to health care is incomplete without guaranteed quality.”

WHO supports medicine regulation by developing internationally recognized norms, standards and guidelines, and by providing technical assistance and training to enable countries to implement global guidelines to meet their specific health needs.

“I believe this achievement will further catalyse other countries in Africa to invest in regulatory systems strengthening to ensure availability and access to quality assured, safe, effective and affordable medical products to their populations. It should also serve to promote confidence, trust and further reliance on authorities attaining this level of maturity,” said Mariângela Simão, WHO Assistant Director General for Access to Medicines and Health Products.

The increase in international trade, technological complexity in manufacturing and product specifications have created additional challenges for national regulatory authorities and manufacturers, particularly to those of developing countries. This requires that national regulatory capacity is regularly assessed and that strong components continue, while areas for improvement are identified and appropriate measures taken.

The WHO assessments of national regulatory systems aim to strengthen oversight and identify both strengths and gaps to inform technical support.

There are four levels of regulatory systems classification starting from Level 1, where only some elements of regulation exist, and up to Level 4 corresponding to the advanced regulatory system. Level 3 indicates that the system is well-functioning and integrates all required elements to guarantee its stable performance.

Ghana’s achievement reaffirms the collaboration between WHO and governments towards realizing the targets of universal health coverage and sustainable development goals. Ghana and Tanzania are the only two of WHO African Region’s 47 countries to have attained a Level 3 ranking. Tanzania achieved the classification in November 2018. WHO is working with countries in the region to improve the performance of their national regulatory systems and facilitate comprehensive oversight of medical products.