ICH E2D(R1) Draft Guideline on Post-Approval Safety Data

The ICH E2D(R1) draft Guideline on “Post-Approval Safety Data: Definitions and Standards for Management and Reporting of Individual Case Safety Reports (ICSRs)” reached Step 2b of the ICH Process in February 2024 and entered the consultation period. The deadline for comments for Europe is 22 June 2024. In addition, a Step 2 Informational Presentation has also been developed by the E2D Expert Working Group and is now available for download on the E2D(R1) page. 

Digital Platforms

The draft guidance updates the existing E2D guidance entitled “E2D Post-Approval Safety Data Management: Definitions and Standards for Expedited Reporting”, published in 2003. The document is intended to clarify the use of new or increasingly used digital platforms (e.g., social media, market research programs, patient support programs) and update terminology and standards for postmarket adverse event reporting.

Digital platforms include social media, web sites, internet forums, chat rooms, and software applications (apps). However, a general distinction should be made between those digital platforms that are under the responsibility of the Marketing Authorization Holder (MAH), and those that are not under the responsibility of the MAH. MAHs should regularly screen digital platforms under their responsibility (i.e. digital platforms, that are owned, controlled, or operated by, or on behalf of, the MAH) for AEs/ADRs (Adverse Events/Adverse Drug Reactions). The frequency of the screening should allow to identify and report AEs/ADRs within the required reporting timeframes. 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. AEs/ADRs identified from an ODCS (Organized Data Collection System) conducted on a digital platform under the MAH’s responsibility should be considered solicited reports and managed according to the documentation describing the ODCS activity.

However, MAHs are not expected to screen or review digital platforms not under their responsibility for AEs/ADRs. If an MAH screens or accesses data from a digital platform not under its responsibility, and the MAH’s activity is conducted in a planned manner consistent with an organized data collection, the MAH should consider the activity to be an ODCS.

Contractual Agreements

The marketing of many medicinal products takes place through contractual agreements between two or more companies, which may market one or more products with the same active substance name in the same or different countries/regions. Pharmacovigilance arrangements vary considerably with respect to inter-company information exchange and regulatory responsibilities. It is important that agreements specify the management and reporting of ICSRs (i.e., processes for exchange of safety information, including timelines and regulatory reporting responsibilities) in accordance with local and regional requirements. Processes should be in place to identify responsibilities and avoid duplicate reporting to regulatory authorities (e.g., clearly assigning responsibility for literature monitoring and ICSR reporting (including from regulatory authority sources)). However, the MAH is ultimately responsible for reporting within the required timelines. Therefore the contractual partners should minimize the data exchange period to enable compliance with MAH responsibilities.

More information is available on the ICH Efficacy Guidelines website.