GXP Engaged Links

European Commission

• http://ec.europa.eu/

EMA (European Medicines Agency)

• www.ema.europa.eu

MHRA (UK competent authority)

• www.mhra.gov.uk

BfArM (German competent authority)

• www.bfarm.de

AGES (Austrian competent authority)

• www.ages.at/

AFFSAPS (French competent authority)

• www.afssaps.fr/

FDA (USA competent authority)

• www.fda.gov

ICH (International Conference on Harmonisation)

• Guidelines for GCP E6: www.ich.org/home.html

EudraLex

• http://ec.europa.eu/health/documents/eudralex/
  (links to all available downloads of guidance documents)

ISO

• www.iso.org/

ENGAGE Auditing Standards

• www.efgcp.be/Downloads/Revised%20ENGAGE%20Auditing%20Guideline.pdf