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Maturity Level Four: FDA involves stakeholders in clinical trials

Health Stakeholders Meeting
Health Stakeholders Meeting

The Food and Drugs Authority (FDA) has engaged stakeholders in the clinical trials industry in Kumasi in the Ashanti Region, as part of its efforts to attain maturity level four as a regulatory body.

Presently, the World Health Organisation (WHO) uses Global Benchmark Tools (GBT) to objectively evaluate national regulatory systems to ensure the quality and safety of medical products to determine the maturity of a country’s system on the scale of one to four.

In April 2020, the FDA became the second regulatory authority in Africa to attain maturity level three following an assessment by the WHO.

To attain maturity level four, the Authority is taking steps to maintain and continuously improve on this stable, well-functioning and integrated regulatory system for medical products.

It is for this reason that the Authority has engaged stakeholders in clinical trials in the region on the updated regulatory requirements.

The meeting, which provided a common platform to discuss current regulatory procedure and policies, also sought to explore the best ways to apply the needed reforms to enhance compliance with local regulatory requirements, while meeting international standards.

It was attended by stakeholders drawn from the Komfo Anokye Teaching Hospital (KATH), Kumasi Centre for Collaborative Research in Tropical Medicine (KCCR), and the Agogo Malaria Research Centre.

Dr Yvonne Adu-Boahen, the Head of Clinical Trials, FDA, said it was important to periodically engage their stakeholders to update and also remind them of the requirements they needed to work with.

She said one of the goals for the engagement was to discuss the public assessment report which was a benchmarking tool for the WHO in assessing the FDA in attaining maturity level four, especially in clinical trials.

“It is good that this information is not just coming from the regulator but also the researchers so that we all work together to be able to publish for transparency to attain the level that we all desire,” she noted.

She said years of engagements with stakeholders had made them understand the rule of the game, making the work of both parties easier.

The FDA, she said, was always open to the public to ensure collective protection of public health and safety.

Dr Joseph Bonney, a participant from KCCR, said clinical trials depended largely on the work of FDA and that the engagement would strengthen the collaboration between the regulator and the institutions.

He said this would go a long way to improve their clinical research to improve the trials and ecosystem in the country, to promote and invite more of such activities.

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