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. In November 2025, AMRH officially handed over their mandate to the African Medicines Agency (AMA) that is now responsible for regulation in the pharmaceutical sector on the African continent with the overall goal of improving access to quality, safe and efficacious medical products for the population.
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 the safety, efficacy, and quality of vaccines and 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 is key to promote best practices in vaccine lot release that ensure product availability and continuous supply in Africa.
The German Development Cooperation, with its implementing organizations, the German National Metrology Institute PTB and the 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.
In March 2026, a two-day workshop on vaccine regulation took place in Accra, Ghana.

OBJECTIVES
To enhance regional collaboration and reliance in vaccine lot release practice.
To discuss on the expansion of the scope of lot release to biologicals beyond vaccines and strengthening its role in ensuring market availability of safe and efficacious products.
To identify operational bottlenecks affecting product availability/continuous access and to propose realistic mitigation actions for regulators and laboratories.
To discuss approaches for emergency/public health surge scenarios (rapid response) while maintaining regulatory control and consistent decision-making.

OUTCOMES
Enhanced collaboration and improved exchange of best practices among regulatory authorities worldwide to ensure consistent and timely lot release practices that support the reliance framework for lot release of vaccines in Africa.
Strengthened mutual trust between regulatory authorities.
Challenges and potential solutions in the expansion of the scope of lot release to other biologicals beyond vaccines identified.
Operational bottlenecks detected and realistic mitigation actions for regulators and laboratories documented.

PARTICIPANTS
NRA's from african countries
Experts from PEI, PTB, WHO, EDQM
Ghana FDA
AMA

LOGISTICS
Timeline: workshop from 26 to 27 March 2026 in Accra, Ghana
26 March: programme at the planned venue
27 March: site visit to Ghana FDA + programme at the planned venue
Venue was in Accra, Alisa hotel – North Ridge (the same hotel where participants stay for the Biomanufacturing Forum)
Laboratory visit at Ghana FDA premises was organized by Ghana FDA (bus transfer etc.).
The workshop language was English.

SPONSORSHIP & FUNDING

Logistics (flights, hotel, transfer) was organized by PTB.

PTB CONTACT

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

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