ICH adopts E2D(R1) guideline on post-approval safety data

The International Council on Harmonisation (ICH) on Wednesday announced the adoption of its E2D(R1) guideline, which aims to standardize terminology related to adverse events and streamline procedures and timelines for collecting and reporting post-approval safety data.

The guideline reached Step 4 of the ICH process on 15 September and is ready for implementation by regional regulators.

The revised guideline provides updated recommendations for managing post-approval safety data, ensuring that they are more in line with current practices and available safety data sources. In a presentation about the guideline, ICH announced that additional training materials will be created to support its implementation.

The 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 regional and local requirements may vary and, as such, marketing authorisation holders (MAHs) should refer to the relevant regional or local regulatory authority’s requirements.”

The guideline was released for public consultation in February 2024. (RELATED: ICH consults on revised post-approval safety guideline that accounts for digital platforms, Regulatory Focus 16 February 2024)

The revised guideline contains only minor differences compared to the draft version. Notable changes include the introduction of a new Section 4.4, which focuses on non-interventional studies involving primary data collection, as well as those utilizing secondary data.

There is a new qualifier language in Section 2.2 regarding the minimum criteria for Individual Case Safety Reports (ICSRs). The updated text states that "regional and local requirements dictate which ICSRs must be reported (e.g., based on seriousness, expectedness, etc.)."

The revision introduces new language that clarifies the definition of a digital platform. Specifically, a digital platform refers to the software and technology that facilitates the transmission of information between users. The updated text specifies that "digital platforms include, but are not limited to, social media, websites, internet forums, chat rooms, mobile health technologies, and software applications (apps)."

The revision also provides another example of an organized data collection system (ODCS). The additional text states that, “In addition, an activity where an MAH monitors and analyzes user communications on a social media site, often referred to as social listening or digital listening, is an example of ODCS.”

The guideline clarifies and standardizes key terms such as adverse events, adverse drug reactions, serious adverse events/adverse drug reactions, and unexpected adverse events/adverse drug reactions. It also details the categories of individual case safety reports, including spontaneous reports and solicited reports.

The guideline also covers reporting timeframes. For example, it states that, “In general, ICSRs that fulfil regional or local criteria for expedited reporting …. should be submitted as soon as possible, but not later than 15 calendar days after day zero.”

The ICH adopted the first version of E2D in November 2003. Since the release of this guideline, new sources of post-approval safety information have emerged or have become more commonly used. These sources include social media, market research programs, and patient support and assistance programs. However, they vary in their characteristics and contributions to the quality of post-approval safety information, as noted in an ICH concept paper.

ICH guideline, presentation

ICH adopts E2D(R1) guideline on post-approval safety data

Related topics

Recommended content

Welcome to the new RAPS Digital Experience