International – Some of the Applicable Regulations

  • ISO Standards : EN ISO 14155

-ISO 14155-1 & ISO 14155-2:

  • ICH Guidelines


-GCP Guidelines ICH E6(R2) 2016:…

  • Declaration of Helsinki, World Medical Association

-Latest Version, Fortaleza, Brazil, 2013 :

  • FDA

-CFR Title 21:

  • Trial Registry

-Clinical Trials:

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