AIMS & SCOPES

From innovation to standards: industry, regulation and standardisation in NAMs and organ-on-chip

Organ-on-chip devices and, more broadly, microphysiological systems are no longer a laboratory promise: they have become tools with a growing role in drug development and in the safety assessment of compounds. The shift is not only technological. The regulatory and standardisation landscape is changing rapidly, and that change now sets the real conditions for industrial adoption.

In June 2026, the European Commission adopted a roadmap towards phasing out animal testing for chemical safety assessments, structuring its actions around existing legislation and giving a decisive push to new approach methodologies, known as NAMs (European Commission, EFSA). In parallel, standardisation is advancing on two mutually reinforcing levels. In Europe, the organ-on-chip standardisation roadmap published by the CEN-CENELEC focus group was developed by some 120 European experts (CEN-CENELEC, Joint Research Centre). Internationally, the new subcommittee ISO/TC 276/SC 2, created in 2024 and dedicated specifically to microphysiological systems and organ-on-chip, is working on terminology, biological components, engineering and manufacturing, experimental design and data management (ISO). This work has already given rise to documents under development on terminology and definitions (ISO/AWI 25448) and on quality control and documentation requirements for biological components (ISO/AWI 25530).

The SESMOOC Symposium 2026 focuses precisely on this meeting point between science, industry and standards. Over a single day in Barcelona we will bring together research groups, companies developing and using these technologies, standardisation bodies and regulatory stakeholders to address one very concrete question: what does it take for an organ-on-chip model developed in a Spanish laboratory to be used, with guarantees of reliability and reproducibility, in a regulatory dossier or in an industrial decision?

The programme will combine the standardisation perspective, with representatives of Spanish and European standardisation bodies; the industrial view of companies already scaling up and commercialising these technologies; and the experience of research and technology centres developing platforms, microfabrication and measurement systems. There will also be exhibition space for sponsoring companies and dedicated networking time, so that the symposium leads to concrete collaborations and not only to an exchange of information.