EMEA: Concept paper on the need for a guideline on the clinical investigation of specific immunoglobulins

Due to the recent increase of submission of marketing authorisation applications for human plasma-derived hepatitis B immunoglobulin (HBIG), several questions regarding the required clinical data arise. Furthermore, compliance to the current available Core SmPC being recommended, a specific guidance relating to the clinical investigation of HBIG products appears appropriate. The expansion of this NfG to all specific immunoglobulins needs to be considered.