Safety Observer

September 2021

Safety Observer 181

Countdown officially started ! The EU Clinical Trials Regulation will enter into force on 31-Jan-2022.

Released 09-Sep-2021
Pages 21

Report 181 — Highlights

EU Clinical Trial Regulation

The notice has now been published in the Official Journal of the EU. As a result, the countdown has started for the entry into application of the Clinical Trials Regulation on 31-Jan-2022.

EU consults on Pharmacovigilance

The European Commission has started a new consultation on proposed changes to the Implementing Regulation (IR) on the performance of pharmacovigilance activities, which was adopted in 2012.

EMA Signal Detection Pilot

The EMA has updated the information on the Signal Detection Pilot, which requires participating MAHs to monitor EudraVigilance data. Further to a prior extension, the Pilot will now run until the end of 2022.

Hong Kong updates PV Guidance

The Drug Office of Hong Kong has published revisions to the existing guidance on Adverse Drug Reaction Reporting Requirements, which now includes details regarding Advanced Therapy Products.

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