In a monumental stride towards enhancing healthcare in Africa, the African Medicines Regulatory Harmonisation (AMRH) in support of operationalization of the African Medicines Agency (AMA) is charting a new course through the Technical Committee on Evaluation Medicinal Products (EMP-TC). This committee, a focal point of the AMRH Initiative, is poised to revolutionize the evaluation, registration, and marketing authorisation of medicinal products across the continent.

Established by the African Medicine Regulatory Harmonisation initiative (AMRH) Steering Committee, the EMP-TC plays a pivotal role in the scientific evaluation of human medicinal products at the continental level. Its responsibilities include harmonising assessment, registration, and marketing authorisation activities at the Regional Economic Communities (RECs) and National Regulatory Authorities (NRAs) levels. The mandate of the EMP-TC is far-reaching and multifaceted.

One of its core responsibilities is the oversight of expert groups that develop technical requirements, guidelines, and product evaluation processes. These resources support assessment activities not only at the continental level but also at regional and national levels. The EMP-TC identifies priority products to be assessed at the continental level and provides guidance on selecting experts who will assist in the assessment process. Moreover, it offers invaluable scientific advice and guidance to manufacturers.

The EMP-TC’s work complements joint assessments conducted at the regional level under RECs and product assessments performed by NRAs. The aim is to prevent duplication of efforts and streamline the evaluation process. In addition, the committee is tasked with organising product assessments for priority items and monitoring the implementation of its recommendations, thereby supporting national decisions for marketing authorisations in various African countries.

A significant milestone was reached in August 2023, when the continental procedure for the assessment of priority products, developed by the EMP-TC, received endorsement from the AMRH Steering Committee, at the Assembly of the 9th African Medicines Regulators Conference (AMRC). This marked the beginning of the implementation of the continental procedure for priority products, kick-started by a pilot project. The pilot project involves the cooperation of assessors and inspectors from REC projects, led by the EMP-TC, with support from the Good Manufacturing Practices Technical Committee and African Vaccine Regulatory Forum (AVAREF).

In a bid to further engage stakeholders and invite manufacturers or suppliers to participate in this groundbreaking initiative, a call for expressions of interest (EOI) has been published   and widely circulated. This call aims to solicit EOIs from entities interested in participating in the piloting of the continental procedure and the processes essential for the operationalisation of the African Medicines Agency.

In pursuit of this ambitious agenda, the AMRH convened a working session of experts to review draft documents. The working groups reviewed the following documents:

• Guidelines on Submission of Data for Listing of Human Medicinal Products
• Guidance for Assessors
• Continental Standard Operating Procedures (SOPs) for EMP-TC Procedure Pilot
• Templates and Forms
• The documents have been adopted and adapted from the guidelines approved in Regional Economic Communities (RECs), the World Health Organization (WHO) Prequalification Program, as well as those from the European Medicines Agency (EMA) and the United States Food and Drug Administration (US FDA) aligning with the guidelines by the International Council on Harmonisation (ICH).

The AMRH Secretariat extended invitations to both full and alternate EMP-TC members, along with experts from each of the RECs’ Medicines Regulatory Harmonization (MRH) projects, and members of the EMP-TC sub-committee on vaccines and other biological products. The invitation was also extended to some of the EMP TC technical partners who also participated in this working session to provide technical assistance to the TWGs. The Technical partners included the PharmTrain-2 project of the Germany’ Global Health Protection Programme implemented by its Federal Institute for Drugs and Medical Devices (BfArM), The Technical Unit of the Supply Division of UNICEF and the World Health Organization (WHO) as a joint Secretariat to the AMRH.

The documents reviewed, developed and adopted/adapted will serve as the foundational resources to support the implementation of the pilot of the continental procedure on evaluation of medicinal products.

These groundbreaking efforts of the EMP-TC, under the broader AMRH Initiative, are poised to redefine the landscape of medicinal product evaluation in Africa. Their focus on harmonization, expertise, and accessibility illustrates the African Medicines Agency’s commitment to paving the way for a healthier and more prosperous future across the entire continent.