Safety Observer 215
India issues revised Pharmacovigilance Guidance for MAHs.
Report 215 — Highlights
MedDRA PtC Companion Document
The MSSO (Maintenance and Support Services Organization) has published Version 3.0 of the MedDRA Points to Consider (PtC) Companion Document, with a new section on coding product manufacturing deviations and non-conformances.
FDA & Electronic Systems
The FDA has published the final guidance entitled “Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations: Questions and Answers”.
EMA Reflection Paper on AI
The EMA has published the final version of the reflection paper on the use of Artificial Intelligence (AI) in the medicinal product lifecycle.
Switzerland & Clinical Trials
Swissmedic has published a revised version of its Information Sheet on Safety Reporting in clinical trials, which will apply from 01-Nov-2024.
India: New PV Guideline for MAHs
The Ministry of Health of India has published the final revision of its “Pharmacovigilance Guidance Document for the Marketing Authorization Holders of Pharmaceutical Products”.
