The Africa Medicines Agency, An Important Step Towards Increasing Timely Availability And Access To Medicinal Products For Patients In Africa

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Wednesday, November 18th 12:30 - 13:30 (Swiss time)


The vision for Africa, particularly in the post Covid-19 world, is that people in every corner of Africa, have timely access to safe, effective, quality medicines, vaccines, medical devices, diagnostics and technology.The increased burden of infectious, neglected tropical, communicable and non-communicable disease is growing rapidly in Africa, coupled with the growing threat of antimicrobial resistance and pandemics.

All medicinal products require effective regulation and multi-disciplinary approaches from appropriate training and capacity building right through to manufacturing and regulatory agility, inspections, effective safety surveillance and ultimately timely access for patients.

The key to optimising sustainability in the supply of medicinal and healthcare products for diseases disproportionately affecting Africa includes a fully established Africa Medicines Agency (AMA), and once the fifteenth country in Africa has ratified the Treaty, the AMA will come into existence.

It will foster regulatory system strengthening and reliance across Africa towards faster and expanded access to medicines, vaccines and biotherapeutics for patients. AMA will coordinate existing regulatory harmonisation efforts in the region and provide regulatory guidance, scientific opinions and a common framework.

The rapid rise of digital health technology promises to deliver medicinal and healthcare products more equitably across Africa. Regulators can streamline approval and procurement of new medicines through secure regulatory harmonisation and adoption of electronic platforms and tools.

People in Africa should have timely access to medicines and to ensure this, consistency and predictability of regulatory systems are needed. This can be achieved through centralising the expertise and optimising the use of scarce resources for review of medicines or conducting inspections. Sound regulatory systems are critical for protecting public health against use of medicinal products which do not meet international standards of quality, safety and efficacy. A consequence of weak or absent regulatory systems is the scourge of falsified and substandard medical products.

One of the key elements for future success of the AMA is to provide an enabling regulatory environment and an effective application of the principle of regulatory reliance. This will need to be underpinned by strengthened governance, regulatory systems, and harmonization efforts across the continent and investment by stakeholders and governments . Equally important is that patient groups and communities have a voice in these developments and participation in the AMA activities.


Catherine Fankan-Bokonga

Senior UN Correspondent, Vice-President of Club Suisse de la Presse & of ACANU (Association des Correspondants Accrédités auprès des Nations Unies)


Mimi Darko

Chief Executive, Food and Drugs Authority

Lodzeni Ellos

Patient Advocate IAPO

Sillo Hiiti

Team Lead, Regulatory Systems Strengthening Team (RSS), WHO

Margareth Ndomondo-Sigonda

Head of Health, Programs at Africa Union Development Agency (AUDA)Head of Health, Programs at Africa Union Development Agency (AUDA)