Links
Reproduced with the kind permission of the Pharmaceutical and Healthcare Sciences Society


British Pharmacopoeia (BP):
http://www.pharmacopoeia.gov.uk/

Health Canada Compliance:
http://www.hc-sc.gc.ca/dhp-mps/compli-conform/indexeng.php

The European Commission DG Enterprise – Pharmaceuticals:
http://ec.europa.eu/enterprise/sectors/pharmaceuticals/index_en.htm

European Commission DG Enterprise – Medical Devices Sector
http://ec.europa.eu/enterprise/medical_devices/index_en.htm

European Medicines Agency (EMA):
http://www.ema.europa.eu/

European Medicines Agency Regulatory and Procedural Guidance:
http://www.ema.europa.eu/htms/human/raguidelines/intro.htm

European Medicines Agency Inspections Sector:
http://www.ema.europa.eu/Inspections/index.html

European Chemical Industry Council – Active
Pharmaceutical Ingredients Sector (CEFIC/APIC):
http://apic.cefic.org/

European Guide to GMP:
http://ec.europa.eu/enterprise/sectors/pharmaceuticals/documents/eudralex/vol-4/index_en.htm

European Compilation of Procedures for GMP Inspections:
http://www.ema.europa.eu/Inspections/GMPCompproc.html

European Federation of Pharmaceutical Industries and Federations (EFPIA):
http://www.efpia.org/

European Guidelines on Quality, Safety, and Efficacy for Human Use Products:
http://www.ema.europa.eu/htms/human/humanguidelines/background.htm

European Guidelines on Quality, Safety, and Efficacy for Veterinary Products:
http://www.ema.europa.eu/htms/vet/vetguidelines/background.htm

European Pharmacopoeia (Ph Eur): http://www.pheur.org/

FDA Home Page:http://www.fda.gov/default.htm

FDA GMP Regulations (CFR21):
http://www.access.gpo.gov/nara/cfr/waisidx_01/21cfr211_01.html

FDA Inspections Operation Manual:
http://www.fda.gov/ICECI/Inspections/IOM/default.htm

FDA Inspection Guides:
http://www.fda.gov/ora/inspect_ref/igs/iglist.html

FDA CBER Guidance / Guidelines / Points to Consider:
http://www.fda.gov/cber/guidelines.htm

FDA Guidance on Drugs:
http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm

Global Harmonization Task Force (GHTF): http://www.ghtf.org/International Conference on Harmonisation (ICH):
http://www.ich.org/UrlGrpServer.jser?@_ID=276&@_TEMPLATE=254

International Society of Pharmaceutical Engineers (ISPE):
http://www.ispe.org/

International Pharmaceutical Federation (FIP):
http://www.fip.nl/www/

International Pharmaceutical Excipients Council (IPEC):
http://www.ipec.org/

Japanese Ministry of Health, Labor and Welfare (MHW):
http://www.mhlw.go.jp/english/

Mutual Recognition Agreements (MRAs):
http://www.emea.europa.eu/Inspections/MRA.html

Pharmaceutical Inspection Co-operation Scheme (PIC/S) -GMP
Guide and basic standards:
http://www.picscheme.org/

Pharmaceutical and Research Manufacturers of America
(PhRMA): http://www.phrma.org/

Risk-Based Approach to Pharmaceutical Current Good Manufacturing Practices (cGMP) for the 21stCentury – Table of contents:
http://www.fda.gov/cder/gmp/gmp2004/GMP_finalreport2004.htm

The Irish Medicines Board: http://www.imb.ie/

The Pharmaceutical Quality Group (PQG): http://www.pqg.org/

The UK Medicines and Health Care Products Regulatory
Agency (MHRA): http://www.mhra.gov.uk/

The MHRA Pharmaceutical Industry Pages:
http://www.mhra.gov.uk/Pharmaceuticalindustry/index.htm

UK GMP (Orange) Guide:
https://web110.securesecure.co.uk/phss.co.uk/?cart=yes&do=item&cid=142

UK Official Documents including Medicines Legislation:
http://www.tso.co.uk/bookshop/bookstore.asp

United States Pharmacopoeia (USP): http://www.usp.org/

World Health Organisation GMP Information (WHO):
http://www.who.int/medicines/areas/quality_safety/quality_assurance/production/en/index.html

Health Canada Compliance:
http://www.hc-sc.gc.ca/dhp-mps/compli-conform/indexeng.php

The European Commission DG Enterprise – Pharmaceuticals:
http://ec.europa.eu/enterprise/sectors/pharmaceuticals/index_en.htm

European Commission DG Enterprise – Medical Devices Sector
http://ec.europa.eu/enterprise/medical_devices/index_en.htm

European Medicines Agency (EMA):
http://www.ema.europa.eu/

European Medicines Agency Regulatory and Procedural Guidance:
http://www.ema.europa.eu/htms/human/raguidelines/intro.htm

European Medicines Agency Inspections Sector:
http://www.ema.europa.eu/Inspections/index.html

European Chemical Industry Council – Active Pharmaceutical Ingredients Sector (CEFIC/APIC):
http://apic.cefic.org/

European Guide to GMP:
http://ec.europa.eu/enterprise/sectors/pharmaceuticals/documents/eudralex/vol-4/index_en.htm

European Compilation of Procedures for GMP
Inspections:
http://www.ema.europa.eu/Inspections/GMPCompproc.html

European Federation of Pharmaceutical Industries and Federations (EFPIA):
http://www.efpia.org/

European Guidelines on Quality, Safety, and Efficacy for Human Use Products:
http://www.ema.europa.eu/htms/human/humanguidelines/background.htm

European Guidelines on Quality, Safety, and Efficacy for Veterinary Products:
http://www.ema.europa.eu/htms/vet/vetguidelines/background.htm

European Pharmacopoeia (Ph Eur): http://www.pheur.org/

FDA Home Page:http://www.fda.gov/default.htm

FDA GMP Regulations (CFR21):
http://www.access.gpo.gov/nara/cfr/waisidx_01/21cfr211_01.html

FDA Inspections Operation Manual:
http://www.fda.gov/ICECI/Inspections/IOM/default.htm

FDA Inspection Guides:
http://www.fda.gov/ora/inspect_ref/igs/iglist.html

FDA CBER Guidance / Guidelines / Points to Consider:
http://www.fda.gov/cber/guidelines.htm

FDA Guidance on Drugs:
http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm

Global Harmonization Task Force (GHTF): http://www.ghtf.org/International Conference on Harmonisation (ICH):
http://www.ich.org/UrlGrpServer.jser?@_ID=276&@_TEMPLATE=254

International Society of Pharmaceutical Engineers (ISPE):
http://www.ispe.org/

International Pharmaceutical Federation (FIP):
http://www.fip.nl/www/

International Pharmaceutical Excipients Council (IPEC):
http://www.ipec.org/

Japanese Ministry of Health, Labor and Welfare (MHW):
http://www.mhlw.go.jp/english/

Mutual Recognition Agreements (MRAs):
http://www.emea.europa.eu/Inspections/MRA.html

Pharmaceutical Inspection Co-operation Scheme (PIC/S) -GMP Guide and basic standards:
http://www.picscheme.org/

Pharmaceutical and Research Manufacturers of America
(PhRMA): http://www.phrma.org/

Risk-Based Approach to Pharmaceutical Current Good Manufacturing Practices (cGMP) for the 21st Century – Table of contents:
http://www.fda.gov/cder/gmp/gmp2004/GMP_finalreport2004.htm

The Irish Medicines Board: http://www.imb.ie/

The Pharmaceutical Quality Group (PQG): http://www.pqg.org/

The UK Medicines and Health Care Products Regulatory Agency (MHRA): http://www.mhra.gov.uk/

The MHRA Pharmaceutical Industry Pages:
http://www.mhra.gov.uk/Pharmaceuticalindustry/index.htm

UK GMP (Orange) Guide:
https://web110.securesecure.co.uk/phss.co.uk/?cart=yes&do=item&cid=142

UK Official Documents including Medicines Legislation:
http://www.tso.co.uk/bookshop/bookstore.asp

United States Pharmacopoeia (USP): http://www.usp.org/

World Health Organisation GMP Information (WHO):
http://www.who.int/medicines/areas/quality_safety/quality_assurance/production/en/index.html

 




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