National reflection on organs-on-chip for drug development: New regulatory challenges

Area of Science:

• Biotechnology
• Drug Development
• Regulatory Science

Background:

• Organs-on-chip (OoC) are advanced in vitro models enhancing preclinical drug development predictivity.
• Lack of regulatory consensus on OoC acceptance criteria impedes widespread adoption.
• France is developing an OoC network to support technological innovation.

Purpose of the Study:

• To address the need for regulatory standardization of OoC technologies.
• To evaluate the technological and biological relevance of liver-on-a-chip models.
• To analyze the current scientific and regulatory landscape for OoC.

Main Methods:

• A reflection was conducted by the National Agency for Medicines and Health products safety (ANSM).
• A list of regulatory requirements for liver-on-a-chip standardization was drafted.
• Literature review was performed to compare liver-on-a-chip models with existing in vitro and in vivo models.

Main Results:

• The study identified key regulatory challenges for OoC adoption.
• Technological and biological relevance of liver-on-a-chip was assessed.
• A foundational list of regulatory requirements for OoC standardization was proposed.

Conclusions:

• Standardization and clear regulatory pathways are essential for the successful implementation of organs-on-chip.
• Liver-on-a-chip models show promise but require further regulatory evaluation.
• International collaboration and national networks are vital for advancing OoC technology.