Safety Observer 181
Countdown officially started ! The EU Clinical Trials Regulation will enter into force on 31-Jan-2022.
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.
