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March 2023

Safety Observer 198

The EMA has produced a new Q&A Document on the Clinical Trials Information System (CTIS) and the EU Clinical Trials Regulation.

Released 08-Mar-2023
Pages 34

Report 198 — Highlights

EU CTR Update

The EMA has published a new Q&A Document on the Clinical Trials Information System (CTIS) and Clinical Trials Regulation (CTR), which covers various aspects including Safety Reporting.

EudraVigilance & Data Privacy

The EMA has sent a letter to EU QPPVs regarding the international transfer of personal data in ICSRs originating from EudraVigilance, highlighting that some MAHs violated European Data Privacy requirements when submitting ICSRs to third countries.

FDA Draft Guidance

The FDA has published a new draft guidance entitled “Considerations for Long-Term Clinical Neurodevelopmental Safety Studies in Neonatal Product Development”.

FDA Public Meetings

The FDA has announced a series of public meetings over the next few months. The topics include the use of ICH E2B(R3), the post approval assessment of cell and gene therapy products, and Immune Globulin (IG) hypersensitivity reactions.


Both the EMA and the MHRA have started a review of medicines containing pseudoephedrine over the risk of specific ischaemic events (PRES and RCVS).

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