Please see below for some useful regulatory and information links.
EMeA - European Medicines Agency - Competent Authority and Regulatory Body is a de-centralised agency covering the whole of Europe, responsible for Europe-wide applications.
MHRA - Medicine and Healthcare Products Regulatory Agency - Competent Authority and Regulatory Body covering the UK.
FDA - Food and Drug Administration Competent Authority and Regulatory Body covering the USA.
PIC/S - Pharmaceutical Inspection Co-operation Scheme - Worldwide body comprising various regulatory bodies that are involved in the standardisation of inspections across the Pharmaceutical industry
ICH - International Council for Harmonisation - WHO driven body that creates standards that will be used for testing of medicines and other quality areas, used worldwide comprising industry and regulatory as well as pharmacopoeial representatives.
EDQM - European Directorate for the Quality of Medicines - mainly responsible for the Ph.Eur.
USP - United States Pharmacopoeia - responsible for the USP and National Formulary.
PQG - Pharmaceutical Quality Group, industry body for improvement of Pharmaceutical Quality.
EFPIA - European Federation of the Pharmaceutical Industries and Associations - A body dedicated to promotion of the Pharmaceutical Industry across Europe.
GMP Guidance:
EMeA (MHRA): http://ec.europa.eu/health/documents/eudralex/vol-4/index_en.htm
FDA: http://www.access.gpo.gov/nara/cfr/waisidx_98/21cfr210_98.html
http://www.access.gpo.gov/nara/cfr/waisidx_98/21cfr211_98.html
PIC/S http://www.picscheme.org/
Regulatory Guidance:
FDA http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/default.htm
MHRA http://www.mhra.gov.uk/Publications/Regulatoryguidance/index.htm
Industry Guidance/Information:
ICH http://www.ich.org/home.html
EDQM (Ph.Eur) http://www.edqm.eu/en/News_and_General_Information-43.html
Useful Information:
PQG http://www.pqg.org/index.php
EFPIA http://www.efpia.org/Content/Default.asp
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