Safety Observer

April 2023

Safety Observer 199

A new MHRA GCP Inspections Metrics Report provides the details on 4 Critical Findings related to Pharmacovigilance.

Released 04-Apr-2023
Pages 33
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Report 199 — Highlights

EMA & Computer Systems

The EMA has published a new guideline that describes the requirements and expectations for computerised systems used in clinical research.

FDA & Electronic Systems

The FDA has published a new draft guidance for comments, which is entitled “Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations: Questions and Answers”. The FDA also announced a webinar to discuss this topic.

FDA guidance on ISO IDMP

The FDA has published a new guidance document on Identification of Medicinal Products, which describes the progress on aligning FDA standards to IDMP standards.

SFDA PV Inspection Report

The Saudi Food & Drug Authority (SFDA) has published the annual report on Pharmacovigilance Inspections conducted in 2022.

MHRA GCP Inspection metrics

The MHRA has published a new GCP Inspections metrics report. The 4 Critical Findings identified during inspections of Commercial Sponsors were all related to Pharmacovigilance deficiencies.

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