Guidelines

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

• Volume 1 Pharmaceutical legislation: Medicinal Products for Use
  ec.europa.eu/health/documents/eudralex/vol-1_en
• Volume 2 Pharmaceutical legislation: Notice to applicants and regulatory guidelines medicinal products for human use
  ec.europa.eu/health/documents/eudralex/vol-2_en
• Volume 3 Scientific guidelines for medicinal products for human use
  ec.europa.eu/health/documents/eudralex/vol-3_en
• Volume 4 Good manufacturing practice (GMP) Guidelines
  ec.europa.eu/health/documents/eudralex/vol-4_en
• Volume 5 Pharmaceutical legislation Medicinal Products for veterinary use
  ec.europa.eu/health/documents/eudralex/vol-5_en
• Volume 6 Notice to Applicants and Regulatory Guidelines for Medicinal products for Veterinary use
  ec.europa.eu/health/documents/eudralex/vol-6_en
• Volume 7 Scientific guidelines for medicinal products for veterinary use
  ec.europa.eu/health/documents/eudralex/vol-7_en
• Volume 8 Maximum residue limits guidelines (MRL)
  ec.europa.eu/health/documents/eudralex/vol-8_en
• Volume 9 Pharmacovigilance guidelines
  ec.europa.eu/health/documents/eudralex/vol-9_en
• Volume 10 Clinical trials guidelines
  ec.europa.eu/health/documents/eudralex/vol-10_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