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
