Industry Regulations

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

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

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