Guidelines and Links
Guidelines
Find out more on guidelines you should now or work with.
Guideline Links
ICH Harmonized Tripartite Guideline Downloads
- Stability testing of new Drug Substances and Products Q1A(R2)
- Download Q1A(R2)
- Photostability testing of new Drug Substances and Products Q1B
- Download Q1B
- Bracketing and Matrixing Designs for Stability Testing of new Drug Substances and Products Q1D
- Download Q1D
- Evaluation for Stability Data Q1E
- Download Q1E
- Quality of Biotechnological Products: Stability Testing of Biotechnological/Biological Products Q5C
- Download Q5C
Guidance for Industry Downloads
- Stability testing of new Veterinary Drug Substances and Medicinal Products (Revision) VICH GL3(R)
- Download VICH GL3(R)
- Stability testing of new Veterinary Dosage Forms
- Download VICH GL4
- Stability testing: Photostability testing of new Veterinary Drug Substances and Medicinal Products VICH GL5
- Download VICH GL5
- Stability testing for Medicated Premixes VICH GL8
- Download VICH GL8
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
Europe
- 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