Safety Observer 199
A new MHRA GCP Inspections Metrics Report provides the details on 4 Critical Findings related to Pharmacovigilance.
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The FDA has published a new draft guidance for comments, which is entitled “Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations: Questions and Answers”.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.
