The European Directorate for the Quality of Medicines & HealthCare (EDQM), Council of Europe, is proud to announce its participation in a major European Union (EU) initiative aimed at strengthening regulatory systems for medicines across Sub-Saharan Africa.
The EDQM, as part of a grant agreement just signed with the European Medicines Agency (EMA), will contribute its internationally recognised expertise in co-ordinating laboratory networks and organising programmes for official medicines control laboratories (OMCLs).
This initiative, part of the European Commission’s “Team Europe Initiatives,” supports the establishment of a continental regulatory model based on reliance, a transformative approach to regulatory co-operation and efficiency. The EDQM’s role will focus on two strategic priorities:
- increasing the capacity and strengthening the capability and competency of the African Medicines Quality Forum (AMQF) and its Networks of African Reliance Laboratories (NARLs)
- enhancing the capacity, capability and competency of individual AMQF National Quality Control Laboratories (NQCLs) to establish, adapt and maintain state-of-the-art quality systems and procedures that are fit for purpose – aligned with their specific duties and supportive of their operational needs.
The EMA’s decision to entrust the EDQM with key components of this project underscores the EDQM’s proven track record in managing international laboratory networks, such as the General European Network of Official Medicines Control Laboratories(GEON). It also highlights the EDQM’s strategic objective to expand its global outreach and impact.
Petra Doerr, EDQM Director, declared on this occasion: “This initiative reflects the EDQM’s commitment to global collaboration and regulatory excellence. "
"By sharing our expertise and supporting the development of robust quality control systems, we are proud to contribute to the operationalisation of the African Medicines Agency and the broader goal of strengthening medicines regulation across Africa.”
Ms Chimwemwe Chamdimba, Head of the African Medicines Regulation Harmonization (AMRH) Programme, commented: “The EDQM’s support to strengthen national quality control laboratories and the African Medicines Quality Forum is a monumental investment in building a strong and sustainable regulatory ecosystem."
"As AMRH, we welcome the EDQM’s partnership in creating a harmonised and efficient regulatory framework across the continent. Their expertise in co-ordinating international laboratory networks will be invaluable as we work together to ensure that all Africans have access to safe, effective and high-quality medicines.”
By leveraging its expertise and networks, the EDQM will work with the AMA to help build a robust and sustainable regulatory framework across Africa, contributing to improved public health outcomes and regulatory resilience.