Three ICH Expert Working Groups have issued an updated document package, a mapping document and training materials, respectively, associated with three technical Guidelines: E2B(R3), M4Q(R2) and E6(R3).<\/p>\n
ICH harmonised Guideline E2B(R3): Individual Case Safety Report Specification<\/strong><\/p>\n The E2B(R3) Expert Working Group has published an Information Paper to explain the alignment of ICH E2B(R3) specifications with the revised ICH E2D Guideline. The E2B(R3) Expert Working Group has also published an Implementation Guide Package with Code List.<\/p>\n The ICH E2D Guideline: Post-Approval Safety Data: Definitions and Standards for Management and Reporting of Individual Case Safety Reports provides guidance on definitions and standards for individual case safety reporting after a product is approved by regulatory authorities, as well as good case management practices. It was updated in September 2025 and the changes have implications for E2B(R3).<\/p>\n Both of these Guidelines are related to ICH\u2019s harmonised electronic standards work, which is advanced by ICH Expert Working Groups and also through joint initiatives with other standards development organisations to ensure global interoperability. Harmonising these electronic standards facilitates electronic exchange of data by regulatory authorities and pharmaceutical companies.<\/p>\n >>> Find the ICH E2B(R3) Information Paper<\/strong> here<\/a>.<\/p>\n >>> Find the ICH E2B(R3) Implementation Guide Package<\/strong> here<\/a>.<\/p>\n ICH M4Q(R2): The Common Technical Document<\/strong><\/p>\n The ICH M4Q(R2) Expert Working Group has issued a Mapping Document to support understanding of revisions to the Quality section of the Common Technical Document. The Mapping Document provides a high level, conceptual mapping between the earlier version, M4Q(R1), which was finalised in 2002, and M4Q(R2), the revised version that is now in development, based on the M4Q(R2) Step 2 version of the draft Guideline<\/a> that was endorsed in May 2025.<\/p>\n The Common Technical Document is a standardised, easy-to-follow format used by pharmaceutical companies when they submit new drug applications to regulatory authorities. Before the development of the Common Technical Document, regions had different documentation requirements, which slowed down the submission of documentation in different regions and also increased the likelihood of errors. The Quality section of the Common Technical Document provides a harmonised structure and format for presenting chemistry, manufacturing and controls information in a registration dossier.<\/p>\n