International – Some of the Applicable Regulations

  • ISO Standards : EN ISO 14155

-ISO 14155-1 & ISO 14155-2: http://www.iso.org/iso/catalogue_detail?csnumber=45557

  • ICH Guidelines

-ICH: http://www.ich.org/products/guidelines.html

  • Declaration of Helsinki, World Medical Association

-WMA: http://www.wma.net/en/30publications/10policies/b3/

-Latest Version, Fortaleza, Brazil, 2013 : https://www.wma.net/policies-post/wma-declaration-of-helsinki-ethical-principles-for-medical-research-involving-human-subjects/

  • FDA

-CFR Title 21: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm

  • Trial Registry

-Clinical Trials: http://www.clinicaltrials.gov/


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