This reflection paper identifies key areas where globally harmonised regulatory guidelines could facilitate the adoption and regulation of advanced manufacturing technologies to improve pharmaceutical development and manufacturing.

Advanced pharmaceutical manufacturing technologies have the potential to improve pharmaceutical quality, provide greater flexibility and agility to the manufacturing process, and enable more timely responses to urgent health issues.

There are opportunities to address advanced manufacturing technologies in both new and existing ICH guidelines. Clear and harmonised expectations would help the development, implementation and regulatory assessment of such technologies, for example, process modelling, including artificial intelligence (AI)-based models, and decentralised or distributed manufacturing.

Ideally, ICH guidelines with globally harmonised regulatory expectations would enable the implementation of agile and flexible networks of manufacturing in different regions and areas.

This reflection paper was endorsed by the ICH General Assembly on 26 January 2026.