Regional collaborative approach central to robust medicines regime in Africa – FDA boss


The Food and Drugs Authority (FDA) CEO, Delese Darko, has asked National Regulatory Authorities (NRAs) to join forces in deepening regional collaborative approaches aimed at achieving a robust Medicines Regulatory Regime for Africa.

Speaking at the opening ceremony of the third African Medicines Regulatory Harmonisation (AMRH) Week in Accra, she said: “The momentum for joint-learning and mentorship is prevalent, and we are keen to grow along with many other NRAs to achieve the audacious vision of a robust Medicines Regulatory Regime in Africa. In the wake of the African Continental Free Trade Area (AfCFTA), it has become even more important for us to deepen our regional collaborative approaches”.

The CEO noted that in 2020 the World Health Organisation designated the Ghana FDA as a Maturity Level 3 agency based on the Globl Benchmarking Tool, and they are working assiduously to achieve ML4.

In August this year, the Drugs Physico-chemical Laboratory of the FDA’s Centre for Laboratory Services & Research attained WHO-Prequalification status.

“These, though no mean feats in themselves, leave us in no doubt of the immense responsibility placed on us to support other NRAs in the region. The momentum for joint learning and mentorship is prevalent and we are keen to grow along with many other NRAs to achieve the audacious vision of a robust Medicines Regulatory Regime in Africa.

“The AfCFTA creates a US$3trillion common market that we – as National Regulatory Authorities – must work hard to secure and protect. As such, the Ghana FDA recently became an anchor partner of the AfCFTA Hub Initiative, a strategic programme of the AfCFTA Secretariat, to accelerate implementation of the AfCFTA single market.”

Further, she stated that the Ghana FDA has been a key driver of the ProPer Seals Initiative, which is laying the groundwork for a pan-African medicines and health commodities traceability, anti-counterfeiting, electronic quality assurance and digital supply chain coordination ecosystem. The ProPer Seals digital platform has indeed already gone live in Ghana, providing all citizens with a free and universally accessible means to instantly verify the status of their health products by using nothing more than a basic phone.

The AMRH has been instrumental in implementing operations of the PAVM, and she believes that this invaluable support will be extended to establishing the African Medicines Agency (AMA).

Since the last AMRH week, which was held virtually in December 2020 due to wide travel restrictions in place for many countries, conversations on COVID-19 have shifted from addressing the urgent short-term needs to building the long-term resilience of our continent with regard to Pandemic Preparedness.

It is therefore no surprise that vaccine production is at the centre of this need, culminating in the establishment of The Partnerships for African Vaccine Manufacturing (PAVM). The first-ever such collaboration for Africa.

PAVM’s laudable continental strategy and framework for action is founded on eight bold initiatives that have been translated into annual priorities for action. This year, our focus is on regulatory process harmonisation, strengthening National Regulatory Authorities (NRAs) and strengthening the Regional Centres of Regulatory Excellence (RCOREs) platform to facilitate vaccine regulatory oversight.

The Food and Drugs Authority (FDA) in Ghana over the past 25 years, with support from our strategic partners, has attained ISO 9001-2015 certification for its technical and administrative operations and the ISO/IEC 17025-2017 accreditation for 58 tests covering allopathic medicines, medical devices, cosmetics and food.

These accreditations, Ms. Darko says, have placed them in a unique position of possessing the largest testing capacity under one roof in Africa. As a Regional Centre of Regulatory Excellence, they have since 2017 strengthened the capacity of more than 151 African Regulators. These include 12 countries in medicine authorisation and registration, seven (7) countries in pharmacovigilance and eleven (11) countries in clinical trial oversight across the continent.

The African Medicines Regulatory Harmonisation (AMRH) is an important platform that was established as a result of the Pharmaceutical Manufacturing Plan for Africa to address weak, outdated and fragmented regulatory systems on the African continent. At its core, the AMRH’s mission is to facilitate and coordinate the harmonisation of medicines-regulation with the desired outcome of increasing access to quality, safe, efficacious and affordable medicines across Africa.

There are numerous reasons why this is critical, but in recent times nothing has brought this closer to home than ravages of the COVID-19 pandemic – from which the world is still recovering.

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