Several years have passed since they started talking about ICH E2B (R3): the first guide was issued in 2014, in November 2017 the transition period began and today the date of the definitive transition is announced.

The International Conference on Harmonization (ICH) has defined E2B as the international standard for the electronic transmission of adverse event reports. From 2001, when the ICH E2B (R2) was implemented, there were several developments in the reporting requirements, which consequently led to the ICH E2B (R3). EMA, in 2019, established that the use of the standard ISO ICSR, based properly on the ICH E2B (R3), is mandatory for reporting of adverse reactions.

The standard will come into force on 30 June 2022 for all safety reports sent to Eudravigilance, the European database for the collection of adverse reactions to drugs authorized in the European Economic Area.

Until that date the two versions, R2 and R3, will continue to coexist. After that, you will need to be ready for the definitive passage that will bring many improvements such as:

  • changes to the message format: data structure, data elements, comments and sender diagnosis, free text for further information available, event severity criteria and evaluation of the correlation between drug and reactions/events
  • introduction of standard terminologies: ISO (country codes, gender codes and language codes), MedDRA (used for example for indication and reaction/event), UCUM (unit of measurement) and ISO IDMP (identification of medicines)
  • more effective protection of patient and consumer data thanks to the new HL7 format
  • greater respect for privacy thanks to the introduction of null flavor
  • improved clarity of interpretation thanks to the introduction of seriousness criteria at the event level.