The World Health Organisation (WHO) on December 5 announced that Rwanda achieved Maturity Level 3 (ML3) in the global classification of national regulatory authorities, making it the eighth country in Africa to reach the milestone.
WHO defines Maturity Level 3 as a stable, well-functioning, and integrated regulatory system for medical products. It is one step below Maturity Level 4 (ML4), the highest classification, which represents an advanced regulatory system.
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Rwanda Food and Drugs Authority (FDA) attained this level following an assessment conducted from 2022 through October 2024, in close collaboration with the WHO Regional Office for Africa and WHO country offices.
According to Emile Bienvenu, the Director General of Rwanda FDA, achieving Maturity Level 3 means that Rwanda established a stable and well-functioning system for regulating medicines and vaccines.
"First of all, I must highlight that reaching this level required significant resources to build a robust and strong system, and this has already been done by the government of Rwanda. It confirms the government's commitment to promoting and protecting public health," he added.
He explained that the achievement opens new opportunities for Rwanda in the global market.
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"Maturity Level 3 means that medicines and vaccines produced in Rwanda are now eligible for WHO prequalification. This allows locally produced products to enter the international market and supply chain," he said.
The recognition also enhances Rwanda's credibility in the global regulatory landscape, he said.
"It means that other countries will start relying on our decisions, just as we have relied on decisions made by other countries in the past. This will allow products made in Rwanda to enter markets that previously depended on other countries' regulatory decisions," he added.
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Achieving Maturity Level 3 opens doors for investment in the pharmaceutical sector and the health sector in general, Bienvenu said.
"It means that investors from other countries will now be more inclined to establish pharmaceutical companies in Rwanda, contributing to the local manufacturing of pharmaceutical products, including vaccines."
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Building on this achievement, Bienvenu noted that Rwanda FDA's next goal is to achieve ML4 and secure designation as a WHO-Listed Authority (WLA).
"This will further enhance its regulatory capabilities and influence on global health," he said.
He added that achieving ML3 demonstrates that Rwanda FDA's regulatory framework, including its laboratory operations, meets the rigorous standards required at this level.
"Our laboratory's trusted testing capabilities play a key role in ensuring the quality, safety, and efficacy of medicines and vaccines through robust and internationally recognised processes."
