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May 2023

Safety Observer 200

The European Commission published proposals for the largest reform of the pharmaceutical legislation in over 20 years.

Released 04-May-2023
Pages 35
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Report 200 — Highlights

EU pharmaceutical reform

The European Commission has published proposals for a new Directive and Regulation to replace the existing pharmaceutical legislation. This is the largest reform in over 20 years but the impact on Pharmacovigilance obligations remains limited.

ICH E6 (R3)

The revision of the ICH E6(R2) guideline on Good Clinical Practice (GCP) aims to address its application to the growing range of clinical trial types and data sources. Both the EMA and the MHRA are setting the scene for the upcoming public consultation.

New FDA Guidance

The FDA has published draft guidance documents for consultation on transdermal and topical delivery systems, one of which covers the assessment of their irritation and sensitization potential.

UK review of isotretinoin

The MHRA has announced the conclusions of their Expert Working Group following the safety review of the acne medicine over the possible persistence of psychiatric and sexual side effects.


A new article explores how Artificial Intelligence (AI) is and may impact Pharmacovigilance in the future.

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