Accelerated Registration of a New Anti-infective Combination in ASEAN Markets: Experience, Insights and Learnings on the ASEAN Joint Assessment (ASEAN JA)

The ASEAN Joint Assessment (ASEAN JA) is a collaborative regulatory initiative among Southeast Asian nations designed to accelerate the approval of essential medicines by enabling simultaneous evaluation and work-sharing among its National Regulatory Authorities (NRAs). This procedure aims to enhance regulatory efficiency, build mutual trust, and facilitate faster patient access to innovative treatments across the region. This article describes a large-scale ASEAN JA application made in accordance with the published ASEAN JA procedures for the registration of a broad-spectrum anti-infective combination aztreonam and avibactam. This application involved six participating ASEAN NRAs and three observer NRAs, marking the largest ASEAN JA attempted to date. The joint assessment proceeded with coordinated timelines and culminated in a joint recommendation to support subsequent national authorization. The joint application supported earlier and more coordinated national submissions across ASEAN markets and showed reductions in approval lead times compared with standard national timelines. Notably, the final approved indications were not fully harmonized across NRAs; two NRA approved narrower indications than the EMA SmPC, while the remaining four NRAs were substantively aligned with the SmPC. Using one common dossier for multiple countries saved resources and reduced submission lag in ASEAN markets, thereby facilitating earlier access to critical medicines for patients in this part of the world. The ASEAN JA initiative reflects ASEAN's commitment to regulatory cooperation while preserving national sovereign decision. Continued enhancements and formalization of ASEAN JA at the national level are expected to further improve access to innovative treatments in the region.