The FDA, which presently holds maturity level three, aims to maintain and improve its regulatory system for medical products to meet international standards.
The World Health Organisation (WHO) employs Global Benchmark Tools (GBT) to assess national regulatory systems objectively, grading them on a scale from one to four. The FDA, having attained maturity level three in April 2020, seeks to elevate its status further.
Stakeholders from institutions such as Komfo Anokye Teaching Hospital (KATH), Kumasi Centre for Collaborative Research in Tropical Medicine (KCCR), and Agogo Malaria Research Centre attended the meeting.
The focus was on discussing updated regulatory requirements, ensuring compliance with local regulations, and meeting international standards.
Dr. Yvonne Adu-Boahen, the Head of Clinical Trials at FDA, emphasized the importance of periodic engagement with stakeholders to update and reinforce compliance requirements.
The meeting aimed to discuss the public assessment report, a WHO benchmarking tool crucial for evaluating FDA's progress towards maturity level four, especially in clinical trials.
Dr. Adu-Boahen highlighted the collaborative efforts between the FDA and researchers, emphasizing transparency for the collective protection of public health and safety.
She stated, “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.”
Dr. Joseph Bonney, a participant from KCCR, emphasized the symbiotic relationship between clinical trials and the FDA.
He expressed optimism that the engagement would strengthen collaboration, leading to improvements in clinical research and fostering a conducive ecosystem for trials in the country.