It is important to establish an internationally standardized procedure to ensure the quality of 17 post-approval safety information and to harmonise, where feasible, the way of gathering and 18 reporting information. The ICH E2D guideline provides guidance on definitions and standards 19 for post-approval individual case safety reporting, as well as good case management practices. 20 This guideline was originally based on the content of the ICH E2A guideline (which provides 21 guidance on pre-approval safety data management), with consideration as to how the terms and 22 definitions should be applied in the post-approval phase of the product life cycle. Detailed 23 guidance on the specific structure, format, standards, and data elements for transmitting 24 Individual Case Safety Reports (ICSRs) is provided in the ICH E2B guideline. Guidance on 25 periodic reporting of aggregated safety data is covered in the ICH E2C guideline.