Entries by Ursula Tschorn

EMA´s Landingpage on IDMP is launched

EMA´s landingpage IDMP on implementation of International Organization for Standardization (ISO) identification of medicinal products (IDMP) standards has been launched. There are described the common standards, formats and terminologies which should be used in the European Union (EU) to identify and exchange pharmacovigilance and medicinal product information. This is a legally binding requirement from the […]

EMA closes the circle between ICSR and XEVMPD by requiring the ISO IDMP´s controlled vocabularies also for ICSRs

The European Medicines Agency (EMA) has published a guide to support the implementation of a new international standard for the safety monitoring of medicines in the European Union (EU). The so-called ISO ICSR standard improves the reporting of suspected side effects of medicines in Individual Case Safety Reports (ICSRs). The use of the new international […]