The Food and Drugs Authority (FDA) has urged researchers in clinical trials to adhere to guidelines of the authority to aid in achieving the World Health Organisation’s(WHO) Maturity Level 4.
“To attain level 4, it is crucial to maintain and enhance stable, integrated regulatory systems. As part of this effort, the FDA has updated regulatory requirements for Clinical Trials Oversight,” says the Head of Clinical Trials Department at the Food and Drugs Authority (FDA),Dr Yvonne Adu-Boahen.
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Dr Adu-Boahen was speaking at a stakeholders in the Clinical Trials Industry in Accra to provide FDA the opportunity to take the appropriate steps towards emerging issues relating to Clinical Trials practice in the country.
About 100 stakeholders included researchers, doctors and pharmacists drawn from across the country attended the meeting.
According to her, the authority’s goal was to make anonymised clinical information in clinical trial application submissions publicly accessible for non-commercial purposes.
Dr Adu-Boahen applauded Ghanaian researchers for the tremendous work done in the Ghanaian clinical trials that helped FDA to obtain the Maturity level 3 in April 2020.
Ghana became the second confirmed country in Africa to achieve the Maturity level 3 for its stable, well-functioning and integrated regulatory system for medical products.
To develop a FDA public Assessment Report( FAPAR), Dr Dr Adu-Boahen stated that,the applicant must submits documents required for the FAPAR to the FDA, FDA compiles the draft FAPAR when the assessment and inspections have been completed successfully, FDA then forwards the draft FAPAR to the applicant for review.
Also, the applicant reviews and comments on the draft FAPAR to ensure that the FAPAR does not contain any proprietary or confidential information, the applicant returns the annotated draft FAPAR to FDA and The FDA publishes the FAPAR and informs the applicant accordingly.
BY CECILIA LAGBA YADA
