57th AEM statement notes signing of Protocol to amend ASEAN Sectoral MRA for GMP inspection of medicinal product manufacturers (entry-into-force pending)

The 57th AEM Joint Media Statement indicates that ASEAN signed a Protocol to amend the ASEAN Sectoral Mutual Recognition Arrangement (MRA) for Good Manufacturing Practice (GMP) inspection of manufacturers of medicinal products, and refers to expected entry-into-force for implementation (without providing a date). This is relevant for pharmaceutical manufacturing and regulatory affairs teams because an updated MRA can change how GMP inspections and recognition of inspection outcomes are conducted across ASEAN, potentially affecting inspection planning, audit readiness, and market authorization support.