Safety Observer 213
ICH issued a revised Reflection Paper on RWD and RWE harmonisation.
Report 213 — Highlights
ICH: RWD/RWE Harmonisation
The ICH Assembly endorsed a revised Reflection Paper on RWD and RWE harmonisation, which follows the public consultation held from June to September 2023.
FDA: New AI Program
The FDA has announced the launch of the new Emerging Drug Safety Technology Program (EDSTP) to promote the use of AI and other emerging technologies in Pharmacovigilance.
FDA Inspections
The FDA has published the final guidance entitled “Circumstances That Constitute Delaying, Denying, Limiting, or Refusing a Drug or Device Inspection”.
EU Variation Regulation
Amendments to the EU Variation Regulation have been published and will apply from 01-Jan-2025. Interested parties are invited to comment on proposed amendments to the associated guidelines.
Botswana PV guidance
The Botswana Medicines Regulatory Authority (BoMRA) has published a revised version of the document entitled “Pharmacovigilance Guidance for Market Authorization Holders”.
