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Datenschutz bei der Infinitemarketing


BfArM-Mustertexte für Fach- und Gebrauchsinformationen


EudraLex - The Rules Governing Medicinal Products in the European Union

  • Volume 1 Pharmaceutical legislation: Medicinal Products for Human Use
  • Volume 2 Pharmaceutical legislation: Notice to applicants and regulatory guidelines medicinal products for human use
  • Volume 3 Scientific guidelines for medicinal products for human use
  • Volume 4 Good manufacturing practice (GMP) Guidelines
  • Volume 5 Pharmaceutical legislation Medicinal Products for veterinary use
  • Volume 6 Notice to Applicants and Regulatory Guidelines for Medicinal products for Veterinary use
  • Volume 7 Scientific guidelines for medicinal products for veterinary use
  • Volume 8 Maximum residue limits guidelines (MRL)
  • Volume 9 Pharmacovigilance guidelines
  • Volume 10 Clinical trials guidelines


FDA Guidances Search FDA Guidances


GMP Navigator Datenbank mit Suchfunktion für Guidelines


ICH International Conference on Harmonization, Guidelines

  • "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


21 CFR Part 11 Übersetzung ins Deutsche (CMC Pharma GmbH)


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