Safety Observer 203
The Australian TGA sets new requirements for the reporting of Safety Issues.
Report 203 — Highlights
FDA: RWD and RWE Studies
The FDA has now published the final guidance on Considerations for the use of Real-World Data (RWD) and Real-World Evidence (RWE) in regulatory decision making.
EMA & AI
The EMA has published a new draft reflection paper for public consultation on the use of Artificial Intelligence (AI) in the medicinal product lifecycle.
Australia: Updated PV Guidance
The Australian TGA has issued an updated version of its Pharmacovigilance Guidance document, which brings new requirements for the reporting of Safety Issues.
MHRA GPvP Inspection Metrics
The MHRA has published a new Pharmacovigilance inspection metrics report, which covers inspections conducted from April 2021 to March 2022.
Pakistan: QPPV/LSO notification
The Drug Regulatory Authority of Pakistan has set a new deadline for companies to comply with the obligation to nominate a Qualified Person for Pharmacovigilance or Local Safety Officer.
