Safety Observer

December 2023

Safety Observer 206

The FDA shared the proposed timelines for implementation of the E2B(R3) standard.

Released 07-Dec-2023
Pages 36
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Report 206 — Highlights

FDA & E2B(R3)

The FDA shared important information at a recent meeting, including the proposed timelines to implementation of the E2B(R3) standard for both premarket and postmarket safety reports.

EMA on ADR Follow-Up

The EMA has published a new Draft Guideline for consultation, which covers the use of specific Follow-Up Questionnaires to improve the completeness of Pharmacovigilance information.

New Medsafe Guideline

Medsafe is requesting comments on a draft revision of its Pharmacovigilance Guideline for New Zealand, which would align the reporting of Safety Issues with Australia.

AEMS Search

The Australian TGA announced that a new search functionality is now available to download cases from the AEMS portal (Adverse Event Management System).

SO: Service Update

As already notified by email, a new method will soon be implemented for the distribution of Safety Observer reports.

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