速報：FDA 2024年 1月16日より、市販後報告 ICH E2B(R3) ICSR 電子報告での受理を開始Breaking News: On January 16, 2024, the FDA began accepting post-marketing reports on ICH E2B (R3) ICSR electronic reports.

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速報：FDAは、2024年 1月16日より、市販後症例での ICH E2B(R3) ICSR 電子報告での受理を開始しました。

https://www.fda.gov/drugs/questions-and-answers-fdas-adverse-event-reporting-system-faers/fda-adverse-event-reporting-system-faers-electronic-submissions

On January 16, 2024, FDA began accepting electronic submissions of both expedited and non-expedited postmarketing individual case safety reports (ICSRs) for human drugs, including biological products regulated by CDER, in electronic format using the E2B(R3) standard endorsed by the International Council for Harmonisation (ICH) and adopted by FDA.

The following timelines apply to companies submitting ICSRs electronically using database-to-database transmission (E2B).

 Option A: Database-to-Database Transmission (“E2B”)

  Option B: Safety Reporting Portal (SRP)

治験報告については、まだ E2B(R3)での受理は開始されていませんのでご注意ください。

なお、E2B(R2)での報告は、２年間引き続受理される暫定期間が設定されています。

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 two (2) years 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.
  • Continue to submit postmarketing ICSRs in E2B(R2) format as you prepare to submit ICSRs using E2B(R3) data standards.
  • Once your company has begun submitting in the E2B(R3) standard, your company may not revert to legacy methods or standards.

取り急ぎ第一報です。