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Safety Observer 237

Latest report   October 2026

Safety Observer 237

The FDA published new information on ICH E2B(R3), which became mandatory for all postmarketing ICSRs submitted via ESG NextGen.

Released 07-Oct-2026

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Past Reports

Safety Observer 236
The EU Commission has published updated Q&As on the EU CTR, including revisions in Chapter 7 on Safety Reporting..
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Safety Observer 235
ICH has published the final version of Annex 2, which complements other components of the E6(R3) GCP Guideline..
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Safety Observer 234
The EMA has updated its guidance intended to clarify aspects of the PSUR single assessment for NAPs..
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