VI.B.8. Modalities for submission of individual case safety reports (ICSRs)

Given the international dimension of adverse reactions reporting and the need to achieve harmonisation and high quality between all involved parties, ICSRs should be submitted electronically as structured data with the use of controlled vocabularies for the relevant data elements where applicable.

With regard to the content and format of electronic ICSRs, competent authorities and marketing authorisation holders should adhere to the following internationally agreed ICH guidelines and standards (see GVP Annex IV) taking into count the transition from ICH-E2B(R2) to ICH-E2B(R3) formats:

• the ICH M1 Terminology – Medical Dictionary for Regulatory Activities (MedDRA), which should be used at the lowest level term (LLT) level in the ICSRs. Stakeholders should follow the recommendations of the MedDRA Maintenance Support Service Organisation (MSSO) regarding the switch to a new MedDRA version14;
• the latest version of the Guide for MedDRA Users MedDRA Term Selection: Points to Consider15;
• the guidelines applicable for the ICH-E2B formats:

As technical standards evolve over time, the above referred documents may require maintenance or revision. In this context, the latest version of these documents should always be taken into account.

EU specific modalities for ICSRs submission and the applicable guidelines, definitions, formats, standards and terminologies are provided respectively in VI.C.4. and VI.C.6.1.