FDA designated Africa Regional Center for Regulatory Excellence in vaccines

 The Food and Drugs Au­thority (FDA), at the just ended 9th African Med­icines Regulators Conference in Kigali-Rwanda, has been 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 move 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 vaccine hub for Africa.

This was announced in the pres­ence of notable figures including Heads of National Medicines Reg­ulatory Agencies, representatives from the African Union Com­mission, Africa CDC, the World Health Organisation, 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 Harmonisation’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.

The authority’s new designation 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 the 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 is expected to 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 it has received for its work.

Notable amongst these are the Presidential Honour conferred on the FDA for its instrumental and sterling contributions towards the containment of the COVID-19 pandemic.

CEO of FDA, Dr Delese Darko, attributed the authority’s ever-growing success to the hard work and dedication of the staff as well as consistent support from the Governing Board, Ministry of Health and development partners.