FDA向けICH E2B(R3) ICSR Reportingが、2026年4月1日から必須要件になります。２年間の E2B(R2)での報告の猶予期間が今年３月末で終了します。
すでに多くの製薬会社のPV部門では、E2B(R3)での FDA電子報告の対応済かとは思いますが、もしまだ E2B(R2)での報告をしている場合は、至急 PV SMEの技術メンバーに相談して対応をすることが必要です。あと、期限までに３ヶ月弱の期間しかありません。ご参考まで。
ICH E2B (R3) ICSR Reporting for the FDA will become a mandatory requirement as of April 1, 2026. The two-year grace period for E2B (R2) reporting will end at the end of March this year.
I believe that many pharmaceutical companies’ PV departments have already responded to FDA electronic reporting in E2B (R3). However, if you are still reporting in E2B (R2), MAHs should consult with the technical members of your PV SME immediately. Also, we only have a little less than three months before the deadline.
“Timelines
- Postmarketing Safety Reporting for human drug and biological products using the E2B standard:
- On January 16, 2024, FDA implemented the E2B(R3) standard for electronic transmission of ICSRs and submitters have until April 1, 2026, to implement E2B(R3) standard for electronic transmission.
- Submitters to FAERS may continue to submit using E2B(R2) data standards for two (2) years during the E2B(R3) implementation period.”
