Korede Abdullah in Lagos
The Africa Centres for Disease Control and Prevention (Africa CDC) has made a significant stride in the fight against epidemic-prone diseases on the continent.
The organization has developed a preferred list of diagnostics to guide efforts in improving access to diagnostic tests for diseases such as Mpox, dengue, cholera, bacterial meningitis, and measles.
These diseases have been prioritized based on criteria outlined in the Target Product Profiles (TPPs).
According to Dr. Noah Fongwen, Senior Technical Officer for Diagnostics Access at Africa CDC on Thursday, specific tests for these diseases will undergo evaluation as part of a pilot program led by the African Medicines Regulatory Harmonisation (AMRH) program in 2025.
Fongwen emphasized the need for harmonization and overcoming barriers to access diagnostic tests, recognizing the role of key organizations such as the African Medicines Agency (AMA) and African Medical Device Forum (AMDF).
“Getting these diagnostics to patients who need them most requires focusing on harmonisation and overcoming barriers to access diagnostic tests,” Fongwen said.
Fongwen also highlighted the complex journey of diagnostics in Africa, where tests often go through a lengthy and fragmented approval process across multiple countries. Some tests can take up to 10 years to be fully adopted. Furthermore,
Fongwen noted the limited production of diagnostic tests in Africa, despite the continent bearing a high disease burden. He emphasized the need to promote local manufacturing to address this gap.
The new continental regulatory process aims to harmonize the regulation of diagnostics in Africa, reducing duplication, accelerating approvals, and enhancing access.
Africa CDC is working closely with the African Union Development Agency (AUDA-NEPAD) and the World Health Organisation to streamline regional and continental harmonisation of regulatory processes for medical devices, including In-Vitro Diagnostics (IVDs).
The pilot implementation plan for the In-Vitro Diagnostics listing procedure is set to run from January 2025 to December 2026.
This continental pilot, led by the AMRH program with support from Africa CDC, will strengthen and harmonize the regulation of in-vitro diagnostics in Africa, ultimately improving access to diagnostic tests for epidemic-prone diseases.
