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FDA rated high on WHO quality standards

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The World Health Organisation (WHO) has benchmarked the Food and Drug Authority (FDA) Ghana to Maturity Level Three of the National Medicine Regulatory System, indicating a well-functioning system to guarantee stable performance.

The new status makes the country the second in Africa to achieve this status in the WHO African Region, with Tanzania being the first to attain that level in 2018.

The new status is the second-highest in the four-tiered WHO classification of a national medicine regulatory system.

Dr Neema Rusbamayila Kumambo, the Acting WHO Country Representative, made the announcement at a short ceremony said the WHO had four levels of regulatory maturity systems starting from Level One.

She said the Level Three, currently attained by Ghana, indicated that the system was well functioning and integrated all required elements to guarantee its stable performance.

Dr Kumambo said the country had indeed strengthened its medicines regulatory system to ensure safety, quality, and effectiveness of medical products manufactured, imported, and distributed within the country.

She said the WHO expected that the status attained would be sustained as its confirmed maintenance in the next two years would document further elevation.

She added that the WHO was proud of Ghana and would continue to provide technical assistance and training to enable the country to implement global guidelines to meet the specific health needs.

Dr Kumambo said the WHO believed that Ghana’s achievement would further catalyse other African countries to invest in strengthening their regulatory systems to ensure availability and access to quality, safe, effective, and affordable medical products to the citizenry.

Mrs Delesse A. A. Darko, the Chief Executive Officer of the FDA, said the Authority always benchmarked against the best global practices to ensure that it was comparable to the most effective and best regulators in the world.

She said having a strong and effective regulatory system played an important role in assuring the quality, safety and efficacy of all medicines and medical products in any jurisdiction.

Mrs Darko said the achievement would better equip the FDA to play its key role in promoting development in both orthodox and traditional medicine industries.

“We will keep working hard to continually improve our systems, products and services, not just as a country but within the African medicines harmonisation initiative to improve public health through support, access to good quality, safe and efficacious medicines,” she added.

She commended Government for the support and the enabling environment adding; “We are proud to achieve this status.’’

“We look forward to playing our role towards the attainment of a Ghana beyond Aid that is built on strong industries supervised by strong world-class regulatory authorities”.

She commended the Board, the Management and Staff for the dedication of service, describing them as priceless.

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