ICH consults on revised post-approval safety guideline that accounts for digital platforms
The International Council for Harmonisation (ICH) recently announced that its new draft E2D(R1) guideline on post-approval data and individual case safety reports (ICSRs) has been released for public consultation.In a separate development, ICH announced the adoption of its Q3C(R9) guideline on residual solvents to incorporate a minor revision for sponsors to consider solvent volatility in choosing an analytical method for testing solvents.
ICH E2D(R1) outlines post-approval data collection
ICH adopted the first version of E2D in November 2003; the guidance aims to establish an internationally standardized procedures to improve the quality of post-approval safety information and to harmonize the way of gathering such information. Yet since the guideline was released, “new sources of post-approval safety information have emerged or are more frequently applied (e.g., social media, market research programs, patient support programs) which vary in characteristics and contribution to quality of post-approval safety information,” according to an explanatory note released with the guideline.
The revised E2D guideline includes a new section on adverse events communicated via digital platforms. Such platforms can include social media, websites, internet forums, chat rooms and software applications. It lists the responsibilities of the marketing authorization holder (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.”
Residual solvents update released
In other news, ICH announced its Q3C(R9) guideline on residual solvents has been adopted and reached Step 4 on 15 February. Under the revision, text is added at the end of Section 3.4 on analytical procedures used to detect residual solvents. The new language states that “the impact of solvent volatility on the test method should be considered in the validation.”
The Q3C guideline was finalized as Step 4 in July 1997, providing recommendations on the acceptable amounts for residual solvents in pharmaceuticals to ensure patient safety.
ICH last revised the guideline in May 2021 when it established new permitted daily exposures (PDEs) for three residual solvents. (RELATED: ICH announces sign-off of residual solvent guideline, Regulatory Focus 3 May 2021)
ICH E2D(R1), Explanatory note, ICH Q3C(R9)
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