ASEAN signs updated ASEAN Framework Agreement on MRAs and signs Protocol to amend the ASEAN Sectoral MRA for GMP inspection of medicinal product manufacturers (entry into force pending)

The 57th AEM Meeting joint media statement notes the signing of an updated ASEAN Framework Agreement on Mutual Recognition Arrangements and the signing of a Protocol to Amend the ASEAN Sectoral MRA for GMP Inspection of Manufacturers of Medicinal Products, with implementation contingent on entry into force. Compliance teams in pharmaceutical manufacturing and supply chains should track entry-into-force and subsequent national implementation, as these instruments can affect reliance on GMP inspections and mutual acceptance mechanisms across ASEAN markets (potentially reducing duplicative audits/inspections once effective).