GDP (Good Distribution Practice)

Title Publisher Issue Date Files
EC
EU Good Distribution Practice of Medicinal Products for Human Use (2013/C 343/01)ECNov-2013[English]
EU Good Distribution Practice of Active Substances for Medicinal Products for Human Use ( 2015/C 95/01 )ECMar-2015[English]
HPRA
HPRA Guide to Good Distribution Practice of Medicinal Products for Human Use (9 MAY 2019)HPRAMay-2019[English]
MHRA
Exceptional good distribution practice (GDP) flexibilities for medicines during the coronavirus (COVID-19) outbreakMHRAApr-2020[na]
US FDA
Guidance for Industry, Product Identifier Requirements Under the Drug Supply Chain Security Act - Compliance PolicyUS FDASep-2018[English]
WHO
WHO Good Trade and Distribution Practices for Pharmaceutical Starting Materials. WHO Technical Report Series, No. 996, 2016, Annex 6WHO2016[English]
WHO Good Distribution Practices for Pharmaceutical Products. WHO Technical Report Series, No. 957, 2010, Annex 5WHO2010[English]
WHO Guide to good storage practices for pharmaceuticals. WHO Technical Report Series, No. 908, 2003, Annex 9WHO2003[English]

GMP (Good Manufacturing Practice)

Title Publisher Issue Date Files
EC
EU GMP Annex 13: Investigational Medicinal ProductsECFeb-2010[English]
EMA
ICH Q7 Good manufacturing practice for active pharmaceutical ingredientsEMA2000[English]
US FDA
Guidance for Industry, Q7A Good Manufacturing Practice Guidance for Active Pharmaceutical IngredientsUS FDASep-2016[English]
WHO
WHO Starting Materials for Pharmaceutical Products: Control and Safe TradeWHO1998[English]
WHO Pharmaceutical Starting Materials Certification Scheme (SMACS): Guidelines on Implementation. WHO Technical Report Series, No. 917, 2003, Annex 3WHO2003[English]
Good Manufacturing Practices: Supplementary Guidelines for the Manufacture of Pharmaceutical Excipients. WHO Technical Report Series, No. 885, 1999, Annex 5WHO1999[English]

COVID-19

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