THE FDA ACHIEVES GLOBAL BENCH-MARKING MATURITY LEVEL 3

The World Health Organization (WHO) has ranked the Food and Drugs Authority (FDA) Maturity Level 3 for its medicines regulatory system that ensures the safety, quality and efficacy of all medical products imported, manufactured or distributed in the country.

The Maturity Level 3 is the second highest in the four-tiered WHO classification of national medicines regulatory systems. This makes Ghana the second country after Tanzania in the African Region and among fifty-one globally to attain this status.

At a short ceremony held at the Ministry of Health office in Accra on 13th May 2020 to announce the significant milestone achievement. Dr. Neema Rusibamayila Kimbo, the WHO country representative, presented a letter that announced that the regulatory system in Ghana has achieved Maturity Level 3 to the Minister of Health, Hon. Kweku Agyeman Manu, the sector Minister under whom the FDA operates.

In her statement, Dr. Kimbo said that the WHO is proud of Ghana's achievement and will continue to support medicine regulation to meet specific health needs.

The WHO supports countries in strengthening their regulatory systems as a means of promoting equitable access to quality assured medical products. This involves the benchmarking of regulatory systems which invites the WHO to apply evaluation tools to generate and analyze regulatory system performance; facilitate the formulation and implementation of institutional development plans; and provide technical support to national regulatory authorities and governments.

Mrs. Delese Mimi Darko, the CEO of the FDA, also noted at the ceremony that the FDA has over the years strived to benchmark against the best global practices to ensure that good regulatory systems for licensing, safety monitoring, clinical trials oversight, marketing authorization, quality control testing, market surveillance among others assure safety, quality and efficacy of all medicines and medical products in Ghana. It is worth noting that this achievement could not have been obtained without technical inputs from the FDA's Technical Advisory Committees as well as tremendous efforts from the Governing Board, Management and staff of the Authority.

The Authority's journey of assessments began in 2014 with the vaccines regulatory system followed in 2015 with medicine regulatory system. An eighteen-member team from The WHO, visited the FDA from the 25th-29th March 2019, to conduct the benchmarking using the enhanced Global Benchmarking Tool with 267 indicators. The team was drawn from the WHO Headquarters in Geneva, WHO Africa Office in Brazzaville and the WHO country office in Accra. An Institutional Development Plan was formulated to guide the FDA to implement the corrective actions and improve on regulatory systems.

A follow up visit was made in February 2020, by a team made up of WHO representatives from Geneva, Brazzaville and the country office, who assessed the implementation of all the recommendations in the Institutional Development Plan. This was followed by subsequent evaluation and monitoring of the FDA's medicines regulation system before the feat of maturity level 3 was attained.

After receiving the letter of recognition, Hon. Agyeman Manu noted that he was proud of the milestone achievement of the FDA. He also noted that there is much confidence that medicines available on the Ghanaian markets are quality assured. He therefore encouraged the FDA to continue to work hard to achieve level 4 maturity as quickly as possible. In a post, Dr. Matshidiso Moeti, the WHO Regional Director for Africa congratulated Ghana and emphasized that "strong national regulatory systems are critically important to ensure that when people seek treatment they receive effective medication and are safe from harm."

The Board Chairman of the FDA, Dr. Sammy Ohene, appealed to the general public to have confidence in the FDA as it seeks to do all it can to keep Ghanaians safe.

There is no doubt that the high-level medicine regulation system will translate into better healthcare delivery in the country.