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Guidelines

Guidelines

EudraLex - The Rules Governing Medicinal Products in the European Union
ec.europa.eu/health/documents/eudralex_en

FDA Guidances Search FDA Guidances

www.fda.gov/regulatory-information/search-fda-guidance-documents

 

GMP Navigator Datenbank mit Suchfunktion für Guidelines

www.gmp-navigator.com

 

ICH International Conference on Harmonization, Guidelines

www.ich.org

  • "Quality" Topics, i.e. Q1 Stability Testing, Q3 Impurity Testing
  • "Safety" Topics, i.e. S1 Carcinogenicity Testing, S2 Genotoxicity Testing
  • "Efficacy" Topics, i.e. E4 Dose Response Studies, Carcinogenicity Testing, E6 Good Clinical Practices
  • Multidisciplinary Topics, i.e.
    M1: Medical Terminology
    M2: Electronic Standards for Transmission of Regulatory Information (ESTRI)
    M3: Timing of Pre-clinical Studies in Relation to Clinical Trials
    M4: The Common Technical Document

 

CFR - Code of Federal Regulations Title 21

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=11

 

21 CFR Part 11 Übersetzung ins Deutsche (CMC Pharma GmbH)
www.cmc-pharma.de/pdf/21CFR11_D.pdf