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…
