1. INTRODUCTION
1.1. Invitation to Manufacturers, Developers or Duly Authorized Applicants African Union Development Agency (AUDA NEPAD) through the African Medicines Regulatory Harmonisation (AMRH) initiative’s African Medical Devices Forum invites manufacturers, developers or applicants of in vitro diagnostics for the detection and/or diagnosis of infection with
the monkeypox (mpox) virus, including in vitro diagnostics that detect and/or diagnose infection with non-variola Orthopoxvirus to submit their expression of intent for a continental facilitated
Expedited Evaluation and Emergency Use Listing.
Manufacturers or developer are invited to a collaborative review process to be facilitated by the African Medical Devices Forum (AMDF). The AMDF-TC will facilitate a collaborative and
expedited review process with experts from national regulatory authorities of countries currently affected by the Mpox outbreak.
1.2. Background
On Aug 13, 2024, the Africa Centres for Disease Control and Prevention (Africa CDC) declared mpox a public health emergency of continental security (PHECS) in Africa which was the
followed by a declaration by the World Health Organization of Mpox as a Public Health Emergency of International Concern.
The decision was driven by the worsening mpox situation on the continent: since 2022, 40 874 cases and 1512 deaths have been reported across 15 AU member states. In 2024 alone, 17 541
cases and 517 deaths have been reported from 13 AU member states. These figures represent a 160% and 19% increase in the number of cases and deaths, respectively, in 2024 compared
with the same period in 2023. A 79% increase in the number of cases was observed in 2023 compared with 2022. The Democratic Republic of the Congo (DRC) accounts for 96% of all
cases and 97% of all deaths reported in 2024.
1.3. The African Medical Devices Forum (AMDF)
The African Medicines Regulatory Harmonization (AMRH) Initiative, established in 2009 as an African Union (AU) Programme, aim to improve regulatory systems across the continent by
working through regional economic communities (RECs). In 2012, the African Medical Devices Forum (AMDF), formerly the Pan Africa Harmonization Working Party (PAHWP), was created by
medical device regulators in Africa to ensure the availability of high-quality, safe, and effective medical devices through harmonized regulations.
In June 2013, the AMDF was officially recognized as a Technical Committee under the AMRH Initiative, providing recommendations on medical device including in vitro diagnostics (IVDs)
regulation harmonization to the AMRH Steering Committee (SC). This integration supports the broader harmonization efforts within the AU, aiming to provide technical and scientific guidance
to all AU member states. With the establishment of the African Medicine Agency (AMA), a continental framework for the regulatory harmonization of medical products, the AMDF is expected to play a technical role in assessing priority medical devices, including in vitro diagnostics (IVDs), strengthening regulatory capacity, and fulfilling other objectives as outlined by the AMA.