As we know, FDA follows on the heels of the EMA, and we can be expecting something to be published by FDA within the year.
The focus of this guidance is on technical implementation. Detailed reporting requirements are out of scope of the guidance document; these are described in Volume 10 of the Rules Governing Medicinal Products in the European Union and in Guideline on good pharmacovigilance practices (GVP) Module VI – Management and reporting of adverse reactions to medicinal products.
The guidance specifies the technical requirements and the process of transmission of Individual Case Safety Reports (ICSRs) and is applicable to all stakeholders, which are exchanging ICSRs electronically within the EEA.
Read the entire guidance here: EMA EU individual Case Safety Report Implementation Guide.