Posted on: Thu 09-01-2025

The Africa Centres for Disease Control and Prevention (Africa CDC) has developed a preferred list to guide efforts to improve access to diagnostics for epidemic-prone diseases on the continent.

Mpox, dengue, cholera, bacterial meningitis, and measles are the priority diseases for which priority diagnostics have been shortlisted based on the criteria outlined in the Target Product Profiles (TPPs).

Speaking at the launch of the priority list of Diagnostics and Advocacy for the Continental Process for Regulation of In-Vitro Diagnostics, Senior Technical Officer for Diagnostics Access, Division of Diagnostic Access, Africa CDC, Dr Noah Fongwen, noted that specific tests for these diseases will undergo evaluation as part of the pilot of the continental process for regulation of in-vitro diagnostics led by the African Medicines Regulatory Harmonisation (AMRH) programme, in 2025 to address key outbreaks.

Fongwen, who spoke on behalf of the Acting Director of the Centre for Laboratory Diagnostics and Systems at Africa CDC, Dr Yenew Kebede, highlighted key processes related to diagnostics and medical devices in Africa.

He said: “Getting these diagnostics to patients who need them most requires focusing on harmonisation and overcoming barriers to access diagnostic tests while recognising the role of key organisations such as the African Medicines Agency (AMA) and African Medical Device Forum (AMDF).

“It’s a complex journey for diagnostics in Africa; diagnostics go through a lengthy and fragmented approval process across multiple countries, and some tests take up to 10 years to be fully adopted.”

Fongwen observed limited production of diagnostic tests in Africa, despite the continent bearing a high disease burden and emphasised the need to promote local manufacturing to address this gap.

Fongwen and Mr Alex Ismail, Programme Officer, Regulatory Systems Strengthening, AUDA-NEPAD, discussed the new continental regulatory process to harmonise the regulation of diagnostics in Africa.

“This process, which will become operational as part of the African Medicines Agency, aims to reduce duplication, accelerate approvals, and enhance access,” Fongwen said.

Africa CDC is working with the African Union Development Agency (AUDA-NEPAD) and the World Health Organisation to streamline regional and continental harmonisation of the regulatory processes for medical devices, including In-Vitro Diagnostics (IVDs),.

SOURCE: GUARDIAN NEWSPAPER

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