The ongoing initiative to strengthen regulatory capacity across the African continent took a significant step forward with the formal integration of the African Union Development Agency–New Partnership for Africa’s Development (AUDA-NEPAD) into the Pharmaceutical Inspection Co-operation Scheme (PIC/S). This milestone reflects a broader commitment to enhancing the quality and safety standards of pharmaceuticals manufactured and distributed across Africa.
In January 2025, the PIC/S Committee officially granted AUDA-NEPAD the status of Associated Partner Organisation, recognizing its strategic role in supporting the development of the African Medicines Agency (AMA). The newly established partnership is underpinned by a cooperation agreement focused on aligning GMP (Good Manufacturing Practice) standards and quality systems for both finished pharmaceutical products and active pharmaceutical ingredients (APIs).
This agreement is designed to streamline the pre-accession and accession pathways to PIC/S for National Regulatory Authorities (NRAs) that are part of the AMA framework. It also aims to provide structured training programs for GMP inspectors, fostering the technical competence and regulatory oversight capabilities of national agencies across the continent.
Moreover, the collaboration is expected to serve as a catalyst for confidence-building measures among African NRAs, reinforcing their capacity to ultimately become full PIC/S Participating Authorities. In the long term, this alignment with international GMP standards will not only improve the regulatory harmonization across Africa but also bolster the global competitiveness and safety of medicines produced within the region.
This development marks a pivotal moment in Africa’s pharmaceutical sovereignty journey, signaling a deeper integration into the international regulatory community and a renewed focus on building resilient, quality-focused supply chains across the continent.