The development of the international standards arising from the International Conference on Harmonization (ICH) of Technical Requirements for Registration of Pharmaceuticals for Human Use topics M5, Identification of Medicinal Products (IDMP) and E2B(R3), Data Elements for the Transmission of Individual Case Safety Reports, are close to finalization and implementation. In this session, attendees will hear about the status of the two related projects from an EMA and FDA perspective and the industry response to this work.