cGMP Guidelines

Find out more about the current Good Manufacturing Practices, and regulations set forth by the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), Health Sciences Authority (HSA), International Council for Harmonisation (ICH), Standards Coordinating Body (SCB), Alliance for Regenerative Medicines (ARM), Therapeutics Goods Administration (TGA), Pharmaceuticals and Medical Device Agency (PMDA) and Pharmaceutical Inspection Co-operation Scheme (PIC/S) in this section.

It contains minimum requirements for the methods, facilities, and controls used in manufacturing and processing.

Below are the links:

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