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

2 Introduction

This document provides best practices and recommendations to configure EDQM Routes of Administration (RoA) and Dose Forms (DF) set up for generating Post-Marketing and Clinical Trial reports using the E2B(R3) profile for EMA, MFDS and NMPA, with Argus Safety.

The International Council for Harmonisation (ICH) published the ICH User Guide: Use of EDQM terminologies for Dose Forms and Routes of Administration for Individual Case Safety Reports in E2B(R3) message on July 2020, version 1.1. The best practices and recommendations presented in this guide are based on this document and its guidelines.

The guidelines include the following:
  • Details about EDQM API to access Standard Terms.
  • Details on how to migrate E2B(R2) Routes of Administration text and Dose Form Text to the EDQM Standard Terms.
  • Recommendations to send EDQM Term ID and version for Dose Formulation (DF) and Route of Administration (RoA).
Regional regulators published the following timelines for accepting EDQM RoA and DF terms:
  • EMA timeline: June 30, 2022
  • MFDS timeline: June 01, 2021
  • NMPA timeline: July 01, 2022