The Food and Drugs Authority (FDA) has engaged stakeholders on the current regulatory procedures and policies on clinical trials of food, medicines, and medical devices to be used in Ghana.
According to the authority, the conduct of trials needs to be regularly updated and enhanced to align with current trends to ensure the protection and safety of patients.
The authority indicated that the regulation of clinical trials in Ghana has advanced over the past 24 years, which has set Ghana up as an example on the African continent.
Head of clinical trials at the FDA, Yvonne Adu Boahene, however, highlighted that one major challenge hindering the success of clinical trials in Ghana is the non-adherence to the FDA’s guidelines by researchers.
Madam Adu Boahene said the authority organises regular trainings for researchers and reviews certifications to ensure that they are updated and conform to the authority’s regulations and guidelines.
“With human institutions, if the researchers are not adhering to the requirements, it becomes a challenge; however, we put in systems and trainings that abreast them with the requirements and update them on new happenings.”
She added that “the stakeholder engagement meeting is a good thing, offering us a face-to-face meeting with the client, our researchers, to touch on reminders and updates and most importantly, being able to publish the process of assessment or review of the application that they conduct the trial with.”
She also disclosed that this is required by the World Health Organization in order to upgrade the FDA’s level of maturity as a regulatory body.
She further called on researchers to exercise caution when submitting their application for approval, as it takes time to conduct a thorough review of applications for clinical trials before they are approved.
“Every researcher may want to put in an application today and have a response tomorrow, but being a confidential and complex application, it takes more than a day. It takes about 30 to 60 days, per our guidelines and the Public Health Act. So we need time to be able to do a thorough and robust work while safeguarding the wellbeing of clinical trial participants.”
Participants also expressed their gratitude for the engagement, which they said will help in the flow of their work.
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