INTRODUCTION

The African Medicines Regulatory Harmonization (AMRH) initiative was launched in 2009 to improve the regulatory systems for medicines in Africa and ensure that safe, effective, and quality medicines are available to patients. One of the key components of the AMRH initiative is the African Medicines Quality Forum (AMQF), which was established in 2015 to promote information sharing, capacity building, and harmonization of medicines quality standards in Africa.
Vaccines are a critical component of the healthcare system, and their availability and continuous supply are essential to prevent and control infectious diseases. Vaccine lot release is an important step in the vaccine regulatory oversight that ensures safety, efficacy, and quality of vaccines. Hence, their safety and efficacy are maintained before they are distributed and administered to healthy populations.
Effective lot release practices are essential to ensure product availability and continuous supply of vaccines in Africa. However, lot release practices can also present challenges to vaccine manufacturers and regulators in the region. The requirements for lot release of vaccines including testing methods may vary between different countries and regulatory authorities, which can lead to delays and inconsistencies in lot release practices. In addition, the growing demand for vaccines and the need for rapid response to public health emergencies can put pressure on lot release function to ensure the timely availability of vaccines.
Therefore, it was essential to promote best practices in vaccine lot release that ensure product availability and continuous supply in Africa. The AMQF, through the AMRH initiative, can play a crucial role in this effort by facilitating collaboration among regulatory authorities and promoting harmonization of lot release practices across the continent.
The German Development Cooperation, with its implementing organizations, the German national metrology institute (PTB) and Gesellschaft für Internationale Zusammenarbeit (GIZ), worked closely with the Paul-Ehrlich-Institut (PEI) to support African regulatory authorities, especially in the field of vaccine regulation.
During the workshop which took place in Dakar, Senegal, the Senegalese Pharmaceutical Regulatory Agency (ARP) shared information on their current lot release procedure as well as on their procedure for technology transfer with vaccine manufacturers. In addition, a tour through the laboratory of Institut Pasteur de Dakar (IPD) and a visit at DICQ’s laboratory was planned for the last day.

OBJECTIVES
The general objective was to strengthen the harmonization of vaccine lot release guidelines across African National Regulatory Authorities (NRAs) towards the operationalization of the Network of African Reliance Laboratories (NARL).

SPECIFIC OBJECTIVES
To develop a model for a product-specific guideline on vaccine lot release through interactive group work and expert input.
To share country-specific experiences, challenges, and achievements in the regulation of vaccines with a focus on identifying areas for benchmarking and collaboration.
To explore capacity-building opportunities within African NRAs with a focus on utilizing the NARL.
To foster the exchange of technical expertise and establish mutual recognition procedures for test results, aiming at streamlining vaccine lot release across the continent.

OUTCOMES
A draft template for a harmonized product-specific guideline for vaccine lot release, adaptable by African NRAs.
Increased awareness of the current challenges and achievements in vaccine regulation across participating countries, facilitating a roadmap for capacity-building and collaboration.
Identification of concrete support mechanisms for African NRAs to enhance their vaccine regulation capabilities through partnerships with RCOREs (Regional Centers of Regulatory Excellence).
Enhanced understanding of technology transfer processes and their application in improving regulatory procedures for vaccines across Africa.

PARTICIPANTS
NRA's from african countries
The workshop language was English with interpretation into French
Experts from PTB, PEI, WHO, EDQM, USP/PQM+ and observers: GIZ
Representatives from the AMRH Initiative
AMQF Leadership

LOGISTICS
Timeline: workshop from 25 to 27 March 2025 in Dakar, Senegal
27 March: visit to laboratory/manufacturer
27 March: AMQF Vaccine Subcommittee Meeting
Venue: Le Ndiambour Hôtel et Résidence, 121 Rue Carnot, Dakar 11000, Senegal; Tel.: +221 33 889 42 89; Email: reservations@lendiambour.com (the same hotel where participants stay)
Laboratory visits at IPD and DICQ facilities; visits were organized by ARP (bus transfer etc.)

SPONSORSHIP & FUNDING
The event was organised and funded by PTB and PEI

PTB CONTACT

Anna Reinhardt, Project Coordinator, anna.reinhardt@ptb.de

Lisa Köhler, Project Assistant, lisa.koehler@ptb.de