Parliament vote clears way for new EU clinical trials rules
This article was originally published in SRA
Executive Summary
The European Parliament has voted through the new Clinical Trials Regulation, which will replace the ageing Clinical Trials Directive and introduce a new single portal for trial authorization, a publicly accessible trials database, and tighter rules on adverse event reporting and informed consent1. A total of 594 MEPs voted for the legislation, with 17 against and 13 abstentions.