1. Usage of EDQM Routes of Administration (RoA) and Dose Forms (DF) Best Practices
  2. Upgrade preparations

3 Upgrade preparations

Organizations need to plan to transition from the old dosage forms list to adopt Standard terms list provided by EDQM, according to the ICH User Guide: Use of EDQM terminologies for Dose Forms and Routes of Administration for Individual Case Safety Reports in E2B(R3) message July 2020 version 1.1.

  • General preparations
    ICH recommends providing the following data to represent EDQM terminology for Dose Form and Route of Administration.
  • Pre-upgrade preparations
    To ensure that the desired RoA and Formulations are available for case processing, organizations need to prepare with the following activities.
  • Post-upgrade
    After upgrade, take the following steps to ensure that the terms for the Routes of Administration and Formulation codelist are correct.
  • Periodic upgrade of EDQM Standard Term list
    Organizations need to update the safety systems regularly to get revised terms published by EDQM.