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September 2023

Safety Observer 203

The Australian TGA sets new requirements for the reporting of Safety Issues.

Released 07-Sep-2023
Pages 44
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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.


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.

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