African medicines regulators and partners convening between 28 October to 1 November 2024 in Maputo, Mozambique adopted a draft plan to launch a Network of African Reliance Laboratoriess (NARL) to increase access to laboratory services and develop or strengthen African National Quality Control Labs’ (NQCLs) capabilities for product quality testing.

The African Union has a strategic plan to locally produce 60% of Africa’s vaccine needs by 2040, but inefficient regulatory systems remain a significant weakness.

Before a registered vaccine can be approved for market distribution, each batch must go through quality and safety assessments by a national control laboratory, a procedure known as “vaccine Lot release.”

This is necessary because, unlike chemical drugs, biological products like vaccines are highly variable, and even small production errors can result in significant changes, explained Kwasi Nyarko coordinator of the Vaccines Research and Innovation Unit at WHO-AFRO to The North African.

Under the NARL program, countries with limited laboratory capacity to conduct these checks will depend on qualified laboratories within the network.

The network will be composed of 6 full members of countries with National regulatory authorities or national control labs at maturity level 3 out WHO scale of 4.

However, During the 18-month pilot phase starting in February 2025, only South Africa and Egypt will be responsible for the testing, as they are the only African nations at WHO’s maturity level 3 for vaccine production.

Full and associate members will rely on them to approve the release of the selected vaccines.

Chimwemwe Chamdimba, Head of the African Medicines Regulatory Harmonization (AMRH) Programme at the African Union Development Agency (AUDA-NEPAD), told the North African: “There was extensive discussion about designating more labs, but we decided not to compromise.”

“We are also working in parallel to strengthen the capacities of other member states, with the ultimate goal of having a reliance lab in each African region,” she added.

Kwasi Boateng, director of the United States Pharmacopeia-Ghana office, a partner of the AMRH initiative, told the North African that while existing networks such as the WHO-National Control Laboratory Network for Biologicals and the European Official Medicines Control Laboratory Network provide valuable learning opportunities, Africa still requires a network specifically tailored to meet its vaccine manufacturing needs.

What will the pilot look like?

Nthabiseng Moiloa, Project Management Officer of the African Medicines Harmonization program (AMRH) explained to the North African that the pilot phase will go through 3 main phases.

The first is to set up and operationalize the governing structure, harmonized Standard Operating Procedures (SOPs) and guidance documents along with a software system for managing information and workflow. At the same time, efforts will be focused on building members’ laboratory capacity through programs offered by AMRH partners and also utilizing the Regional Centres of Regulatory Excellence.

The AMRH has 15 regional centers across almost all African regions, with new centers for vaccines regulatory oversight designated in Egypt, Ghana, South Africa and Tanzania.

The second is to publish the call for manufacturers to participate in the pilot by providing product samples, which will then be shipped to labs within the network for testing.

Afterward, NARL members, manufacturers and other stakeholders will meet to assess the pilot outcomes and identify areas for improvement.

An offshoot for the African Medicines Agency

Shortly after the meeting, Rwanda, which was selected 2 years ago to host the African Medicines Agency (AMA), officially handed over the newly built eight-story AMA headquarters to the African Union.

The AMA treaty, which came into effect in 2021, has now been ratified by 29 AU member states. The agency is expected to become operational next year following the appointment of its director-general.

“All the pilots that we are currently conducting through the AMRH are meant to pressure-test processes and procedures in readiness for the full operationalisation of the African Medicines Agency”, Moiloa added.

Moiloa noted that the lab network will be linked with other AMRH initiatives, including the ongoing continental pilot for listing of human medicinal products, which this year gathered 100 medicine dossier assessors from across Africa for the first time.

“Even after these medicinal products pass the continental evaluation stage, some vaccines will be targeted for quality testing, a gap that NARL can help fill. Furthermore, once the products are released into the market, continuous monitoring will be necessary, and our post-marketing surveillance subcommittee will collaborate with the lab network to ensure their safety and efficacy,” Moiloa added.

In the near future, the scope of NARL is intended to eventually include medicines and medical devices, but we plan to approach this gradually so we don’t bite more than we can chew, Moila noted.