Links

Find out more on Standards

Drug Evaluation:
Official website for ICH (International Conference of Harmonisation) http://www.ich.org
Center for Drug Evaluation and Research (CDER) of the FDA http://www.fda.gov
ISPE (International Society of Pharmaceutical Engineers) http://www.ispe.org
GAMP (Good Automated Manufacturing Practice) http://www.ispe.org
 
GLP
EMEA Good Laboratory Practice http://www.emea.eu.int
US-GLP http://www.iph.fgov.be
 
GMP
EMEA Good Manufacturing Practice http://www.emea.eu.int
European Commission - GMP http://dg3.eudra.org/F2/pharmacos/gmp_doc.htm
Eudralex Volume 4: GMP http://dg3.eudra.org/F2/eudralex/index.htm
GMP Guide http://www.gmp-navigator.com
 

Authorities and institutions
International
International Conference on Harmonisation (ICH) guidelines http://www.ich.org
Weltgesundheitsorganisation (WHO) http://www.who.int/en/
 
US
US Food and Drug Administration (FDA) http://www.fda.gov
National Institutes of Health (NIH) http://www.nih.gov
 

Europa
Europäische Kommission
Enterprise DG – Pharmaceuticals
Regulatory framework and Market authorisations		 http://dg3.eudra.org
The Heads of Agencies http://heads.medagencies.org
European Commission Enterprise DG http://dg3.eudra.org
EurLex - das Portal zum Recht der Europäischen Union http://europa.eu.int
European Directorate for the Quality of Medicines (EDQM) http://www.pheur.org
Europäische Arzneimittelagentur (EMEA)
 http://www.emea.eu.int/
 
Germany
Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM) http://www.bfarm.de
Paul-Ehrlich-Institut (PEI) http://www.pei.de
Robert Koch Institut (RKI) http://www.rki.de
Deutsches Institut für Medizinische Dokumentation und Information (DIMDI) http://www.dimdi.de
Bundesinstitut für Risikobewertung (BfR) http://www.bfr.bund.de
Bundesministerium für Gesundheit und Soziale Sicherung (BMGS) http://www.bmgs.bund.de
Bundesministerium der Justiz (BMJ) http://www.bmj.bund.de
Bundesärztekammer (BÄK) http://www.bundesaerztekammer.de
Regsource http://www.regsource.com
http://www.regsource.com