African Union Development Agency (AUDA NEPAD) through the African Medicines Regulatory Harmonisation (AMRH) initiative’s Evaluation of Medicinal Products Technical Committee (EMP-TC) invites manufacturers or applicants of medicinal product intended for treatment or prevention of Mpox to submit their expression of intent for a continental Expedited Evaluation and Emergency Use Listing.
Categories of candidate medicinal products that may be considered for this call include unlicensed or unauthorized products, repurposed products as well as products authorized by acknowledged reference regulatory authorities. Mpox vaccines or any other medicinal products such as antiviral medicinal products intended for treatment of mpox are eligible.
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.
Under the African Medicines Regulatory Harmonization (AMRH) Initiative, several Technical Committees (TCs) have been put in place to spearhead regulatory systems strengthening and harmonization in Africa working with Regional Economic Communities (RECs) medicines harmonization initiatives and National Regulatory Authorities (NRAs). Recently these technical committees have been working to lay a foundation and conduct joint regulatory reviews and inspections in support of the operationalization of the African Medicines Agency (AMA) whose Treaty came into force in November 2021.
Specifically, the Evaluation of Medicinal Products Technical Committee (EMP-TC) was established by the AMRH Steering Committee to play a vital role in the scientific evaluation of human medicinal products at continental level and to coordinate and conduct the assessment of applications for the priority medicinal products as guided by its Guidance on Eligibility Criteria for Priority Medicinal Products and provide scientific recommendations to support product registration and marketing authorization at national levels. In accordance with this Guidance, medicinal products intended for Public Health Emergency are considered eligible for Continental pathway through the EMP-TC and based on the continental guidelines for Emergency Use Listing.
The EMP TC’s continental procedure for evaluation of medicinal products and guidance for priority products eligibility criteria were approved by the AMRH Steering Committee and adopted by the Assembly of the 9th African Medicines Regulators Conference in August 2023.
How will the Emergency Evaluation and Listing Process be like?
The EMP TC will undertake an expedited comprehensive evaluation of the quality, safety, and efficacy of the candidate vaccine based on dossiers submitted by the applicants and on an assessment of the GMP/GCP/GLP compliance through relevant continental technical committees under AMRH.
Based on the Continental Guideline for Emergency Use Listing where evaluation demonstrates that a product and its corresponding manufacturing and clinical site(s) meet the continental standards acceptable by the Technical Committees (i.e., internationally acceptable standards) for products meant for Public Health Emergency, the medicinal product will be issued with an INDEPENDENT SCIENTIFIC OPINION or RECOMMENDATION which will then allow the product to be included in the continental list (listing) of medicinal products recommended by the EMP-TC (if positive).
The assessment as well as inspection reports will be shared with concerned National Regulatory Agencies (NRAs) in Africa to support and facilitate registration and marketing authorization of the product.
The EMP TC may also publish negative opinion if deemed appropriate in the interest of public health.
Product listed by the EMP-TC will be published on the AUDA NEPAD website and will inform the Africa CDC Pooled Procurement Mechanism.
SUBMISSION OF EOI
Who can Apply?
Manufacturers or suppliers (Applicants) of Mpox Vaccines or any other categories of medicinal products that may be considered for an EUL (including unlicensed products, repurposed products).
What to submit for the EoI?
An Expression of Intent (EOI) letter for product evaluation at continental level to be submitted by the applicants (manufacturer or supplier duly authorized) along with the self-screening checklist on the eligibility of products (self-screening checklist can be accessed https://amrh.nepad.org/amrh-resources).
Where and when to submit the EoI?
Send the EOI to the following mailbox addresses: emp@nepad.org cc alexj@nepad.org
The window for submissions of EOI is opened from the 27th of August 2024.