Useful Links

• European Commission
• EMA (European Medicines Agency)
• MHRA (UK competent authority)
• BfArM (German competent authority)
• AGES (Austrian competent authority)
• ANSM (French competent authority)
• FDA (USA competent authority) (21 CFR Title Search)
• FDA (USA competent authority) (Warning Letters)
• FDA (USA competent authority) (Guidance Documents)
• ICH (International Conference on Harmonisation) Guidelines for GCP
• EudraLex (links to all available downloads of guidance documents)
• HHS Edition of the International Compilation of Human Research Standards
• International Standards Organisation (ISO)
• National Institute of Standards and Technology (NIST)
• Institute of Electrical and Electronics Engineers (IEE)
• Federal Office for Information Security
• German Society for Good Research Practice
• Research Quality Association
• Drug Information Association
• Society of Good Clinical Data Management