Regulatory Framework
The evolving policy landscape enabling human-relevant medicine in drug development
FDA Modernization Act 3.0
The FDA Modernization Act 3.0 (2022) removed the requirement for animal testing before human clinical trials, opening the door for organ-on-chip, organoid, and computational models to serve as primary safety evidence.
Key Provisions
- Eliminates mandatory animal testing requirement
- Enables "alternative testing methods"
- Includes organ-on-chip and in silico models
- Applies to all FDA-regulated products
Impact
- Faster drug development timelines
- Better human-relevant safety data
- Reduced development costs
- Ethical advancement in research
NCATS Tissue Chip Program
The National Center for Advancing Translational Sciences (NCATS) Tissue Chip Program has invested over $200 million in developing and validating microphysiological systems for drug development.
EMA Guidelines
The European Medicines Agency has issued qualification opinions for organ-on-chip and organoid models, establishing pathways for regulatory acceptance of NAMs data in drug submissions.
Qualification Opinion
Formal EMA process for evaluating novel methodologies. Multiple organ-on-chip systems have received positive opinions.
ICH Guidelines
International harmonization efforts to align NAMs acceptance across FDA, EMA, and PMDA regulatory bodies.
Saudi Vision 2030 Healthcare Transformation
$64 billion investment in precision medicine, genomics, and biotechnology infrastructure
Key Developments
King Faisal Specialist Hospital
Gene and cell therapy manufacturing facility launching October 2025. First CAR-T manufacturing in Middle East.
NEOM Health City
$500B megaproject with dedicated biotech research zone and advanced healthcare infrastructure.
KAUST Partnerships
King Abdullah University collaborations on microphysiological systems and AI-driven drug discovery.
Saudi Genome Program
National genomics initiative sequencing 100,000+ Saudi genomes for precision medicine applications.
Investment Opportunities
- Cell and gene therapy manufacturing
- AI-powered diagnostic platforms
- Precision oncology services
- Microphysiological systems research
- Healthcare technology infrastructure
Regulatory Topics
In-depth coverage of regulations governing NAMs and human simulation technologies
FDA Modernization Act
End of animal testing mandates
FDA Modernization Act 3.0
Latest amendments
FDA ISTAND Program
In silico trials support
EMA 3Rs Guidelines
European approach
ICH Guidelines
International harmonization
OECD Guidelines
Global testing standards
EPA NAMs Strategy
Environmental toxicology
NCATS Tissue Chip
NIH chip program
ARPA-H Initiatives
Health moonshots
Explore Resources
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