Industry Regulations

GDP (Good Distribution Practice)

Title	Publisher	Issue Date	Files
EC
EU Good Distribution Practice of Medicinal Products for Human Use (2013/C 343/01)	EC	Nov-2013	[English]
EU Good Distribution Practice of Active Substances for Medicinal Products for Human Use ( 2015/C 95/01 )	EC	Mar-2015	[English]
HPRA
HPRA Guide to Good Distribution Practice of Medicinal Products for Human Use (9 MAY 2019)	HPRA	May-2019	[English]
MHRA
Exceptional good distribution practice (GDP) flexibilities for medicines during the coronavirus (COVID-19) outbreak	MHRA	Apr-2020	[na]
US FDA
Guidance for Industry, Product Identifier Requirements Under the Drug Supply Chain Security Act - Compliance Policy	US FDA	Sep-2018	[English]
WHO
WHO Good Trade and Distribution Practices for Pharmaceutical Starting Materials. WHO Technical Report Series, No. 996, 2016, Annex 6	WHO	2016	[English]
WHO Good Distribution Practices for Pharmaceutical Products. WHO Technical Report Series, No. 957, 2010, Annex 5	WHO	2010	[English]
WHO Guide to good storage practices for pharmaceuticals. WHO Technical Report Series, No. 908, 2003, Annex 9	WHO	2003	[English]

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GMP (Good Manufacturing Practice)

Title	Publisher	Issue Date	Files
EC
EU GMP Annex 13: Investigational Medicinal Products	EC	Feb-2010	[English]
EMA
ICH Q7 Good manufacturing practice for active pharmaceutical ingredients	EMA	2000	[English]
US FDA
Guidance for Industry, Q7A Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients	US FDA	Sep-2016	[English]
WHO
WHO Starting Materials for Pharmaceutical Products: Control and Safe Trade	WHO	1998	[English]
WHO Pharmaceutical Starting Materials Certification Scheme (SMACS): Guidelines on Implementation. WHO Technical Report Series, No. 917, 2003, Annex 3	WHO	2003	[English]
Good Manufacturing Practices: Supplementary Guidelines for the Manufacture of Pharmaceutical Excipients. WHO Technical Report Series, No. 885, 1999, Annex 5	WHO	1999	[English]

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COVID-19

Title	Publisher	Issue Date	Files
EMA
Guidance to sponsors on how to manage clinical trials during the COVID-19 pandemic	EMA	Mar-2020	[English]
US FDA
FDA Issues Guidance for Conducting Clinical Trials	US FDA	Mar-2020	[English]
WHO
WHO Country & Technical Guidance - Coronavirus disease (COVID-19)	WHO	Mar-2020	[English]

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