Regulatory acceptance of organ-chips and organoids requires rigorous validation against established standards. Key frameworks include OECD Test Guidelines, ICH guidance documents, FDA qualification pathways (DDT, ISTAND), and IQ MPS consortium recommendations for standardization.
KEY FRAMEWORKS
OECD
Test Guidelines
OECD TG 497 (Defined Approaches for Skin Sensitisation) demonstrates pathway for NAM validation and adoption.
FDA ISTAND
Pilot Program
Innovative Science and Technology Approaches for New Drugs provides formal pathway for MPS qualification.
ICH
S9 Guidelines
International harmonization for nonclinical evaluation; evolving to incorporate NAMs where appropriate.
IQ MPS
Consortium Standards
Pharmaceutical industry consortium developing standardization recommendations for MPS adoption.