Module 1 2021
25/06/2021
ICH Members
• Regulatory Members • ANVISA, Brazil • HSA, Singapore • MFDS, Republic of Korea • NMPA, China • TFDA, Chinese Taipei • Industry Members • BIO
• Founding Regulatory Members • FDA, US • EC, Europe • MHLW/PMDA, Japan • Founding Industry Members • EFPIA • JPMA • PhRMA • Standing Members • Health Canada, Canada • Swissmedic, Switzerland
• IGBA • WSMI
The Organisation for Professionals in Regulatory Affairs
11
ICH Observers
• Regional Harmonization Initiatives (RHIs) • APEC • ASEAN • EAC • GHC • PANDRH • SADC
• Standing Observers • IFPMA, • WHO
• Legislative or Administrative Authorities • CDSCO, India • CECMED, Cuba • COFEPRIS, Mexico • INVIMA, Colombia • MMDA, Moldova • National Center, Kazakhstan • NPRA, Malaysia • NRA, Iran • Roszdravnadzor, Russia • SAHPRA, South Africa • SCDMTE, Armenia • TGA, Australia • TITCK, Turkey
• International Pharmaceutical Industry Organisation • APIC
• International Organizations Regulated or Affected by ICH Guideline(s) • Bill & Melinda Gates Foundation • CIOMS • EDQM • IPEC • PIC/S • USP
The Organisation for Professionals in Regulatory Affairs
12
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