The ICH E2D(R1) draft Guideline on “Post-Approval Safety Data: Definitions and Standards for Management and Reporting of individual Case Safety Reports” reached reached Step 2 of the ICH process on 5 February 2024.
The ICH E2D guideline provides guidance on definitions and standards for post-approval individual case safety reporting, as well as good case management practices.
ICH E2D(R1) EWG (Expert Working Group) established in 2019 to revise E2D to support appropriate post-market safety surveillance as original ICH E2D guideline was adopted in 2003 and there are new sources of post-market safety information have emerged (or are used more often) which vary in characteristics and contribution to post-market safety surveillance (e.g., patient support programs (PSPs) and social media). Current definitions and regulatory guidance in the original ICH E2D document are no longer sufficient to provide guidance on current pharmacovigilance practices and needs.
The revised E2D guideline added definitions for Other Observations, Reporting Terminology, Individual Case Safety Report (ICSR) including Minimum Criteria for Reporting, Expedited Report and Primary Source, Digital Platforms, Organised Data Collection System (ODCS), Patient Support Programs (PSP), Market Research Program (MRP). There were also updates to What Should be Reported? and other observations sections.
The guidelines also updated the concepts of “Spontaneous Reports and Solicited Reports which were moved from section ‘Sources of ICSRs’ to new section ‘Types of ICSRs’ as they are report types rather than sources”. Included guidance on the management of safety communications by HCPs and consumers by source to regulatory authorities or other Organisation(e.g., WHO) and marketing authorisation holders (MAHs) – “For the purposes of ICSR reporting, if these reports are received as spontaneous, then the “Type of Report” in ICH E2B format should be classified as “spontaneous report”. If gathered as part of an ODCS (i.e., solicited), then the “Type of Report” in ICH E2B format should be classified as “report from study”“.
There were extensive updates to the literature section, in order to clarify important topics, including screening of medical and scientific journals by MAHs and vendors and clock start date (day zero) and clarified expectations for reporting when the specific brand or trade name of the product is ambiguous or unknown. Provided recommendations to include important findings from literature in Periodic Safety Reports, when applicable.
The revised E2D guideline also includes a new section on adverse events communicated via digital platforms which replaced internet section from current guidance document. Such platforms can include but not limited to social media, websites, internet forums, chat rooms and software applications. It lists the responsibilities of the MAH if they own, control, or operate the digital platform. It states that “MAHs should regularly screen digital platforms under their responsibility for AEs/ADRs. The frequency of the screening should allow for the MAH to identify and report AEs/ADRs within the required reporting timeline…AEs/ADRs should be managed as spontaneous or solicited depending on the context in which the MAH received the report: for example, AEs/ADRs spontaneously reported by patients on any part of an MAH’s product website should be managed as spontaneous reports and AEs/ADRs identified from an ODCS conducted on a digital platform under the MAH’s responsibility should be considered solicited reports”.
There was also a proposal to add a new values in E2B (ICSR reporting format) to identify cases from ODCS on Digital Platforms, patient support programs and market research programs. https://database.ich.org/sites/default/files/ICH_E2D%28R1%29_Explanatory_Document_2024_0205.pdf
Refer to the complete document for all the changes and updates
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