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GVP Module XVI Addendum II, E2D(R1), E2B(R3) mandates, and recent ICH/EMA revisions.
9 terms
EMA revision (2025) to GVP Module XVI on risk minimization; adds guidance on effectiveness evaluation of risk minimization measures and pregnancy prevention programmes.
ICH guideline (Step 4 Sept 2025) on post-approval safety data management; harmonizes definitions and handling of post-marketing ICSRs globally.
FDA requirement (April 2026) for structured electronic submission of adverse events in ICH E2B(R3) format; replaces older formats for FAERS.
Risk minimization programme to prevent fetal exposure (e.g., contraception, testing, education). GVP XVI Addendum II requires effectiveness evaluation.