**INTRODUCTION **
It is important to establish an internationally standardised procedure to ensure the quality of postapproval safety information and to harmonise, where feasible, the way of gathering and reporting information. The ICH E2D guideline provides guidance on definitions and standards for post approval individual case safety reporting, as well as good case management practices. This guideline was originally based on the content of the ICH E2A guideline (which provides guidance on pre-approval safety data management), with consideration as to how the terms and definitions should be applied in the post-approval phase of the product life cycle. Detailed guidance on the specific structure, format, standards, and data elements for transmitting Individual Case Safety Reports (ICSRs) is provided in the ICH E2B guideline. Guidance on periodic reporting of aggregated safety data is covered in the ICH E2C guideline.
This guideline provides recommendations that are harmonised to the extent possible given differences in post-market safety reporting requirements among ICH regions. Where applicable, this guideline notes where local and regional requirements may vary and, as such, marketing authorisation holders (MAHs) should refer to the relevant local or regional regulatory authority’s requirements.
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