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Ready for US-FDA E2B(R3) Safety Reporting from April 1st?

Navigating the Electronic Pharmacovigilance Transition Effective April 1, 2026, the U.S. Food and Drug Administration (FDA) will make the use of the ICH E2B(R3) electronic format mandatory for all Individual Case Safety Report (ICSR) submissions and will no longer accept legacy format filings after this date. Implementation began in early 2024, covering postmarketing reports in [...]