Safety Observer 206
The FDA shared the proposed timelines for implementation of the E2B(R3) standard.
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.
