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International Pharmacoepidemiology Legislation

The conduct of pharmacoepidemiology studies are regulated by pharmacovigilance legislation which varies by region and country throughout the globe. These regulations and resulting definitions and requirements are summarised in guidance documents for study sponsors and other individuals involved in study conduct. The International Society for Pharmacoepidemiology (ISPE) and the MAPI Research Trust (MRT) have teamed up to provide a central resource summarizing these regulatory guidelines for individual countries where guidance documents can be located. This is an on-going project, so if you have corrections or further information, please write to us at

Click on a country to get info.