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

• Volume 1 Pharmaceutical legislation: Medicinal Products for Human Use
  http://ec.europa.eu/health/documents/eudralex/vol-1/index_en.htm

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