Africa CDC & partners launch new initiative to harmonize diagnostics access for health security across the continent

ETHIOPIA – The Africa Centre for Disease Control and Prevention (Africa CDC), has led a new coalition to launch the Africa Collaborative Initiative to Advance Diagnostics (AFCAD).

The coalition will be under the African Medical Device Forum (AMDF) which is the Technical Committee under the Africa Medicines Regulatory Harmonization (AMRH) program of the Africa Development Agency-New Partnership for Africa’s Development (AUDA-NEPAD).

The coalition will be positioned to operationalize the new AMA treaty in the domain of medical devices and IVDs.

AFCAD will address four key objectives i.e. promote local manufacturing of diagnostics, map, identify and build capacity of diagnostic centres of excellence (the Africa Biobanking Network).

The new coalition will facilitate harmonization of regulatory processes and requirements, and global market negotiation. 

It will also bring the much-needed change in access to diagnostics, which has to be supported by regional and continental harmonization of the regulatory processes for medical devices including Invitro Diagnostics (IVDs).

Breaking down the AMA treaty and its role in medical devices regulation 

In recognition of the need to strengthen the capacity for regulation of medical products in Africa, and the harmonization of medicines regulatory systems as a foundation for the establishment of a single regulatory Agency.

Moreover, the AU Executive Council through its decision in January 2015 endorsed the establishment of the African Medicines Agency (AMA).

AMA will oversee the continental regulatory harmonization of medical products such as medicines, vaccines, and medical devices including IVDs, and is expected to be a significant boost for access to medical countermeasures in Africa.

Africa CDC is supporting the AMRH program through AMDF to close the gap between the laboratory and regulatory work streams for IVDs. 

Africa CDC will provide this support by mapping and building capacity in laboratories that will serve as centers of excellence for the validation of IVDs (biobanking networks) and establishing a Diagnostics Advisory Committee (DAC). 

AMDF Technical Committee meeting to endorse a new paradigm shift 

In line with this, Africa CDC organized a joint meeting among the AMDF Technical Committee, representatives of the AMRH program, and the newly formed DAC from August 15-17, 2023 in Dakar, Senegal.

In this meeting, the diagnostic Advisory Committee composed of 15 well-experienced laboratory experts representing all regions of Africa and a few partners was officially established and Terms of Reference (TOR) were endorsed.

Dr. Yenew Kebede, Head of Division of Laboratory Systems at Africa CDC said, “Access to quality assured IVDs remains a major challenge in Africa significantly impacting the disease control and prevention efforts.”

Dr. Kebede added that the establishment of the DAC was an important milestone in the implementation of comprehensive strategies outlined under the AFCAD initiative and the TOR of the DAC was aligned with the AMDF and the AMRH programme.

In this meeting, the plans and progresses in the operationalization of the AMA and strategic objectives and activities of the AMDF technical committee were presented and reviewed. 

Chimwemwe Chamdimba, Head of the AMRH program at AUDA-NEPAD mentioned, “The collaboration between AMRH program under AUDA-NEPAD and Africa CDC in the area of harmonization of regulatory processes for medical products including IVDs is a testimony of the unity of purpose of the Africa Union agencies to effectively address bottlenecks to increase access to medical countermeasures for better health outcomes.”

Dr Paulyne Wairimu the Chair of the AMDF Techinical Committee added that the establishment of DAC in this joint meeting will complement our effort in establishing harmonized processes for the regulation of medical products.

“The establishment of the DAC is a welcoming development and it is a significant input in the work of the AMDF technical committee,” Dr. Wairimu continued.

Dr. Wairimu reiterated that DAC would continue to support the mapping of the center of excellence for the evaluation of IVDs, provide technical support during evaluation and create a list of diagnostics for priority diseases and facilitate the registration of the products by national regulatory authorities.

At the end of this meeting, Africa CDC and AUDA NEPAD’s AMRH program through the AMDF outlined the key next steps as a continental effort to accelerate access to diagnostics.

The DAC will play a pivotal role in advancing the above key steps and contribute its part in the advancement of diagnostics for disease prevention and control efforts.

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