Encap Drug Delivery

Useful Links

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

EMeA               http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/landing/human_medicines_regulatory.jsp&murl=menus/regulations/regulations.jsp&mid=WC0b01ac058001ff89

Industry Guidance/Information:

ICH                   http://www.ich.org/home.html

EDQM (Ph.Eur) http://www.edqm.eu/en/News_and_General_Information-43.html

USP                 http://www.usp.org/

Useful Information:

PQG                 http://www.pqg.org/index.php

EFPIA               http://www.efpia.org/Content/Default.asp

 

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