FDA chalks major milestone; designated as RCORE in vaccines regulatory oversight in Africa


The Food and Drugs Authority (FDA), Ghana has once again chalked a major milestone on the African continent.

At the just-ended 9th African Medicines Regulators Conference in Kigali, Rwanda, the FDA was designated a Regional Center of Regulatory Excellence (RCORE) in Vaccines Regulatory Oversight in Africa by the Africa Union Development Agency – New Partnership for Africa’s Development (AUDA-NEPAD).

This is a move that underscores FDA Ghana’s commitment to strengthening the vaccine regulatory capacity of other regulatory authorities in Africa. The RCORE designation is also in alignment with the Government of Ghana’s agenda to make Ghana the national vaccine hub for Africa.

This announcement was made in the presence of notable figures, including Heads of National Medicines Regulatory Agencies, representatives from the African Union Commission, Africa CDC, the World Health Organization, and the Bill and Melinda Gates Foundation.

The FDA Ghana’s expression of interest to be considered as an RCORE in Vaccines Regulatory Oversight was reviewed by the African Medicines Regulatory Harmonization’s (AMRH) Independent Review Group. The AMRH Steering Committee approved the Review Group’s recommendation for FDA Ghana to be designated as RCORE in Vaccines Regulatory Oversight for the following functions: (i) Overarching regulatory system, (ii) Marketing authorisation, (iii) Vigilance, (iv) Market surveillance and control, (v) Licensing of premises, (vi) Regulatory inspections, (vii) Laboratory access & testing, and (viii) Clinical trials.

It is worth noting that this new designation of FDA as an RCORE institution for Vaccine Regulatory Oversight actually constitutes an addition to its already existing RCORE status for marketing authorisation, vigilance, and clinical trials for medicines since 2014. Over that period, it has trained more than 158 regulators from 17 countries (francophone, anglophone and lusophone) in Africa.

As an RCORE in Vaccines Regulatory Oversight, the FDA – in conjunction with selected universities in Ghana – will support other regulatory authorities in Africa in the following areas: (a) technical training; (b) skills enhancement through twinning and exchange programmes; (c) practical training for pharmaceutical industries; and (d) pilot testing of innovations and interventions related to vaccines. The FDA’s Drug Physicochemical Laboratory, which attained a WHO Maturity Level 4 status and as a result has been designated a WHO Prequalified Quality Control Laboratory, will provide an excellent learning experience.

This important recognition of FDA Ghana as an RCORE for Vaccines Regulatory Oversight comes on the back of several other national and international awards given to the FDA in recent times.  Notable among these is the Presidential Honor conferred on the FDA for its instrumental and sterling contributions toward the containment of the COVID-19 pandemic.

The Chief Executive Officer of Ghana’s FDA, Dr. Delese Darko, attributed this success to the hard work and dedication of the staff as well as the support the authority continues to receive from the Governing Board, Ministry of Health, and development partners.





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