A New Regulatory Era for New Approach Methodologies: Reflections from the International Society of Organoid Research

The recent publication of the European Commission's Roadmap Towards Phasing Out Animal    Testingfor Chemical Safety Assessments and the U.S. Food and Drug Administration's (FDA)      draft guidance on Streamlined Nonclinical Safety Studies for Biologics and Conjugated Products for Oncology Indications may represent one of the most significant developments in regulatory    science in recent years.

The European Commission roadmap establishes a strategic framework aimed at accelerating the development, validation, and regulatory acceptance of non-animal approaches for chemical

safety assessment across the European Union. Rather than proposing an immediate elimination of animal testing, the roadmap outlines a long-term vision for reducing reliance on animal

models while maintaining high standards of protection for human health and the environment.

Similarly, the FDA's draft guidance reflects an evolving regulatory approach to nonclinical safety assessment by recognizing circumstances in which streamlined testing strategies and

alternative sources of evidence may provide sufficient information to support decision-making for certain oncology biologics and conjugated products. The guidance signals a growing

willingness to evaluate evidence based on its scientific relevance and predictive value rather than relying exclusively on traditional testing paradigms.

Although these initiatives arise from different regulatory frameworks and address distinct sectors, they share a common message: the future of safety assessment and biomedical

innovation will increasingly depend on scientifically robust New Approach Methodologies  (NAMs) capable of generating evidence that is relevant, predictive, and reflective of human biology.

Importantly, both initiatives highlight an equally important reality: the successful integration of NAMs into regulatory decision-making requires not only scientific innovation but also

validation, transparency, and regulatory confidence. As interest in human-relevant methodologies continues to grow, so too does the need for frameworks capable of supporting their reliable and consistent implementation.

From the perspective of the International Society of Organoid Research (ISoOR), these developments represent an important milestone in the growing recognition of advanced human- derived biological systems and their expanding role in biomedical research, healthcare innovation, and regulatory science. Organoid technologies have progressed far beyond their

origins as laboratory research tools. Today, they are contributing to drug discovery and development, precision medicine, toxicity assessment, disease modeling, and emerging

regenerative medicine applications. Their ability to generate biologically relevant and clinically   meaningful information places them among the most promising technologies within the broader   NAMs landscape and aligns closely with the growing regulatory emphasis on predictive, human- centered evidence.

For the organoid community, this evolving regulatory landscape presents both opportunity and responsibility. As organoid technologies continue to mature, their potential role in supporting biomedical research, therapeutic development, safety assessment, and personalized healthcare is becoming increasingly evident. At the same time, their broader adoption will depend on the ability of the field to demonstrate reproducibility, reliability, and fitness for purpose across diverse applications.

This challenge extends beyond organoid science alone. Regulatory acceptance of any emerging  technology depends on confidence in the quality of the systems used to generate data. Scientific advances must therefore be accompanied by robust standards, quality frameworks, and governance mechanisms capable of ensuring consistency, traceability, and transparency.

It is within this context that the work ofISoOR and the independent accreditation organization ISoOR-AB becomes particularly relevant. Recognizing the growing need for internationally

harmonized frameworks, ISoOR launched the ISoOR-ISOB Standard for Organoid Biobanking   in March 2025. Developed through the collaboration of leading international experts in organoid science, biobanking, quality management, standardization, accreditation, and regulatory affairs,   the standard establishes requirements for the governance, characterization, traceability, quality    management, storage, and distribution of organoid-derived biological resources.

Complementing this effort, ISoOR-AB operates as an independent accreditation body responsible for assessing conformity with the ISoOR-ISOB Standard. Through independent

assessment and accreditation activities, ISoOR-AB contributes to strengthening confidence in organoid biobanks and supporting the implementation of internationally recognized quality

principles. Together, ISoOR and ISoOR-AB are helping to build the quality infrastructure  necessary for the responsible development and broader adoption of organoid technologies.

The significance of the recent European Commission and FDA initiatives therefore extends beyond the reduction of animal testing. These developments signal a broader commitment to   advancing scientifically rigorous NAMs and accelerating the adoption of approaches that may improve the prediction of human responses, support innovation, and enhance decision-making across research, industry, and healthcare.

For ISoOR, this moment represents both validation and responsibility. Validation because regulatory authorities are increasingly recognizing the value of NAMs and the importance of human-relevant evidence. Responsibility because the scientific community must continue to  generate the evidence, standards, and quality frameworks required to support their effective   implementation.

Through international collaboration and the active engagement of experts from academia, industry, regulatory agencies, standardization bodies, healthcare institutions, and accreditation    organizations, ISoOR and ISoOR-AB remain committed to contributing to this global effort. As organoid technologies continue to evolve, the establishment of robust scientific and quality

infrastructures will be essential to ensuring that their full potential can be realized. The recent initiatives from the European Commission and the FDA suggest that this future is no longer a distant aspiration but an emerging reality—one in which the organoid community has an important role to play.