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We need to improve on integrated regulatory systems for medical products - FDA

In its quest to achieve Maturity Level four (ML4) in Africa, the Food and Drugs Authority (FDA) has stressed the need to maintain and improve a stable, well-functioning and integrated regulatory systems for medical products.

Date Created : 3/21/2024 12:00:00 AM : Story Author : Victoria Agyemang/Ghanadistricts.com

The Ghana FDA was ranked second in African to attain ML 3 following an assessment by the World Health Organization (WHO) and needed to do more to move a step ahead of the feat.

Madam Francisca Obeng , the Central Regional Head of the FDA, said the Authority would be able to achieve the mark if it rigorously engaged stakeholders to educate them on the updated regulatory requirements, including its oversight of clinical trials.

At a workshop for stakeholders in the medicine industry in Cape Coast, she said there was the need for regular and frequent engagements of stakeholders in the clinical trials industry to help protect the public in safe medicine and food.

She said it became very evident during the Ebola Virus Disease (EVD) crisis in 2015 and more recently the novel SARS-Cov-2 virus popularly known as COVID-19 in 2020 that regular clinical trials were done in that direction.

She said research was dynamic requirement in the conduct of trials needed to be regularly updated and enhanced to align with current trends to ensure the protection of patients' safety, rights and well-being while maintaining data credibility.

The meeting was aimed at giving participants a unique opportunity and platform to discuss updates in current regulatory procedures and policies.

Also, it was to explore best ways to implement reforms needed to enhance compliance to local regulatory requirements while meeting international standards before, during and after the conduct of clinical trials in Ghana.

Madam Obeng urged participants to go through the right procedures and channels in conducting research for public safety.

On FDA’s Public Assessment Reports (FAPAR), Mr. Richard Osei Buabeng, Head of Clinical Trails and Compliance Unit, FDA said health professionals should ensure that their research were regulated by the Authority and could meet international standards.

Failure to adhere to FDA requirements and regulations could attract a penalty of 150,000 penalty units or a jail term of 25 years.

He assured the public that every trial that went through the FDA requirements and procedures were done in relation to international standards with the wellbeing and safety of Ghanaians remaining their topmost priority as centered by their tag line.

For his part, Dr. Edwin Nkansah, Director of Vaccine, Vigilance and Clinical Trials of FDA took participants through the laws, mandates, roles and responsibilities of the FDA to ensure public health and safety.

He appealed to the participants to discuss and engage the Authority all the time to ensure collective agreement, and safeguard public health.

Participants from the health sector were drawn from the Central and Western Regions.

They were from Cape Coast Teaching Hospital, Effia Nkwanta Regional Hospital, the St Francis Xavier Hospital and other health centres within the two Regions.