Relevant International & Local Regulations

Quick Link to relevant international and local regulations for your reference.

Below are the links:

1. U.S. Food and Drug Administration (FDA)
   • FDA Cellular Gene Therapy Guidances
2. European Medicines Agency (EMA)
   • EMA Cell Therapy and Tissue Engineering Guidelines
3. Health Sciences Authority (HSA)
   • HSA Regulatory Overview
4. International Council for Harmonisation (ICH)
   • ICH Guidelines
5. Standards Coordinating Body (SCB)
   • SCB Guidance and Regulations
6. Alliance for Regenerative Medicines (ARM)
   • Alliance for Regenerative Medicines
7. Therapeutics Goods Administration (TGA)
   • Australian Regulatory Guidelines for Biologicals (ARGB)
8. Pharmaceuticals and Medical Device Agency (PMDA)
   • PMDA Guidelines
9. Pharmaceutical Inspection Co-operation Scheme (PIC/S)
   • PIC/S Publications