Pharmazeutische Zeitung Online
AMK
Links

Guidelines

Datenschutz bei der PZ

Guidelines

BfArM-Mustertexte für Fach- und Gebrauchsinformationen

www.bfarm.de/DE/Arzneimittel/zul/amInformationen/mufag/_node.html

 

EudraLex - The Rules Governing Medicinal Products in the European Union

http://ec.europa.eu/health/documents/eudralex/index_en.htm

 

FDA Guidances Search FDA Guidances

www.fda.gov/RegulatoryInformation/Guidances/default.htm

 

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

 

Office of Regulatory Affairs. Compliance References: Title 21 CFR Part 11

www.fda.gov/ora/compliance_ref/part11