Egypt Joins Africa’s Top Medicines Regulators in Signing MoU on Regulatory Reliance

The Egyptian Drug Authority (EDA) has joined the National Regulatory Authorities (NRAs) of Ghana, Nigeria, Rwanda, Senegal, South Africa, Tanzania, and Zimbabwe — all of which are recognized by the World Health Organization (WHO) as having achieved Maturity Level 3 (ML3) – in signing the Memorandum of Understanding (MoU) on regulatory reliance.

The signing ceremony took place on the sidelines of the Africa Health ExCon 2025 held June 24 – 27 in Cairo, Egypt.

In his remarks at the signing ceremony, Dr. Ali Ghamrawy, Chairman of the Egyptian Drug Authority (EDA), said the MoU signifies a shared institutional commitment to building an integrated regulatory ecosystem across Africa, emphasizing that this alignment reflects a collective resolve to strengthen the continent’s pharmaceutical and regulatory sovereignty by fostering oversight mechanisms rooted in partnership, regulatory equivalence, and mutual reliance.

For her part, Mrs. Chimwemwe Chamdimba, Head of the African Medicines Regulatory Harmonisation program at AUDA-NEPAD, expressed strong appreciation for this institutional alliance, stressing that this collective effort is central to the AMRH’s ongoing agenda to harmonize medical products regulation across the continent. The MoU establishes a structured framework to accelerate regulatory processes for medicines, vaccines, and medical devices by leveraging the scientific assessments and decisions of fellow ML3 NRAs.

Mrs. Chimwemwe Chamdimba, Head of the African Medicines Regulatory Harmonisation (AMRH) programme at AUDA-NEPAD, expressed deep appreciation for the institutional alliance, highlighting its importance to AMRH’s broader agenda of harmonizing medical products regulation across Africa. She noted that the MoU provides a structured framework to expedite regulatory processes for medicines, vaccines, and medical devices by relying on the scientific assessments and decisions of peer ML3 National Regulatory Authorities (NRAs).

Dr. Abebe Genetu Bayih, Coordinator of the Platform for Harmonized African Health Products Manufacturing (PHAHM) at Africa CDC, warmly welcomed Egypt’s inclusion in the group of eight National Regulatory Authorities (NRAs) signing the Memorandum of Understanding (MoU). He highlighted the MoU as a vital instrument for advancing Africa CDC’s strategic agenda on local health product manufacturing, emphasizing that effective implementation is paramount to translating commitments into action.

Egypt’s joining of the Coalition brings together all African WHO ML3-NRAs under a unified platform. The signatories commit to streamlining application submissions and evaluation procedures to accelerate regulatory timelines, lower operational costs, and facilitate timely, efficient decision-making across participating authorities. This will be achieved through enhanced information sharing, collaborative work-sharing, and reliance—whether partial or full—on the scientific assessment reports and regulatory decisions of participating authorities.