Safety Observer 186
The new EU Clinical Trial Regulation became applicable as the CTIS went live on 31-Jan-2022.
Report 186 — Highlights
CTIS goes live
The new EU Clinical Trial Regulation (EU No 536/2014) became applicable as the EMA launched its Clinical Trials Information System (CTIS) on 31-Jan-2022.
EU CTR Q&As
The European Commission has published a revised version of the Q&A Document supporting the implementation of the Clinical Trials Regulation (EU) No 536/2014, which is now applicable.
ISO & ICSRs
It will become mandatory to report ICSRs to EudraVigilance in compliance with international ISO standards from 30-Jun-2022. The EMA has published information to prepare for the changes.
Clinical Trials in the UK
The MHRA has launched a consultation on proposals to improve and strengthen the UK clinical trials legislation, streamline clinical trial approvals and enable innovation.
MHRA GPvP Metrics
Safety Observer has produced a new article on its website, which provides the key learning points from the latest MHRA Pharmacovigilance inspection metrics report.
