FDA accepts challenge to maintain standards

The Food and Drugs Authority (FDA) says it has accepted the challenge to maintain standards and even improve upon its status as World Health Organisation (WHO) listed Level Three regulatory body.

The listing of the Ghana FDA makes Ghana one of the 51 elite countries globally to have attained the WHO Level Three listing.

Hardworking
Responding to the challenge in an interview, the Chief Executive Officer (CEO) of the FDA Mrs Mimi Delese A.A. Darko gave the assurance that the staff, “will keep working hard to continually improve our systems, products and services, not just as a country but within the Africa medicines harmonisation initiative to improve public health through support access to good quality safe and efficacious medicines.”

The FDA was last month rated a WHO Level Three listed institution after meeting 267 WHO benchmarks backed by documentation as having a stable, well-functioning and integrated regulatory system.

Ghana thus becomes the second African country after Tanzania to achieve such a feat, making the Ghana FDA comparable to any regulatory body in the world.

The Board Chairman of the FDA Dr Sammy Ohene challenged the staff to work towards attaining the WHO maturity Level Four.

Attaining WHO Maturity Level Four means that the regulatory system is operating at advanced level of performance and continuous improvement.

Highest quality standards
But Mrs Darko stated that the Ghana FDA had over the years strived to attain highest quality standards by always making positive changes to improve its systems and services.

“So, we benchmark against the best global practices to ensure that as an agency we are comparable to the most effective and best regulators in the world,” she said, adding that the target of the FDA was to reach the ultimate Level Four to rub shoulders with the renowned regulatory bodies such as the American FDA.

Giving praise and thanks to God for the achievement, Mrs Darko said the authority was humbled by the recognition given it, “by no less a body than the WHO”, saying that for Ghana to have been named as WHO Level Three listed country and among the 51 countries globally, meant that the FDA was doing something right to merit that and it was an honour for its staff.

“We are proud to achieve this status and we thank government for the support and enabling environment. We look forward to playing our role towards the attainment of a Ghana Beyond Aid that is built in strong industries supervised by strong and world class regulatory authorities.

Gratitude
“FDA management and staff you are priceless - especially the hard-working staff from licensing, safety monitoring, clinical trials, marketing authorisation, quality control Laboratory, market surveillance, regulatory system as a whole - Thank you for all your hard work.

“You continue to dedicate yourself and your time to ensure that we have access to safe medical products and vaccines even under usually challenging circumstances and little remuneration,” she said.

Processes
Commenting on the achievement in a separate interview, the Ag Deputy Chief Executive (Drug Registration and Inspectorate Division) Mr Seth Seaneke took the Daily Graphic through the processes leading to the attainment of the level three status.

He said in March 2019, Ghana's FDA applied to be considered for listing as a WHO Level Three listed regulatory body, “and a year down the lane, here we are, joining the few elites in the world.”

He said the assessors assessed the functional areas of the authority; namely the Medicine Registration, Marketing Surveillance, Good Manufacturing Practice Inspection, Laboratory Testing, Pharmacovigilance, Clinical Trials and the Regulatory System itself.

Mr Seaneke was proud to add that by the time the assessors completed their assessment, it was realised that Safety Monitoring, one of the seven functional areas was already at Level 4 while two other areas, the laboratory and clinical trials were expected to complete few documentation requirements to attain the Level Four within the year.

He explained that the WHO, played a pivotal role in supporting countries in strengthening their regulatory systems and promoting equitable access to quality, safe, efficacious, and affordable medical products and health products.