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)
https://www.fda.gov/vaccines-blood-biologics/biologics-guidances/cellular-gene-therapy-guidances
European Medicines Agency (EMA)
Health Sciences Authority (HSA)
https://www.hsa.gov.sg/ctgtp/regulatory-overview
International Council for Harmonisation (ICH)
https://www.ich.org/page/ich-guidelines
Standards Coordinating Body (SCB)
https://www.standardscoordinatingbody.org/guidance-regulations
Alliance for Regenerative Medicines (ARM)
Therapeutics Goods Administration (TGA)
https://www.tga.gov.au/publication/australian-regulatory-guidelines-biologicals-argb
Pharmaceuticals and Medical Device Agency (PMDA)
https://www.pmda.go.jp/english/pnavi_e-08.html
Pharmaceutical Inspection Co-operation Scheme (PIC/S)