Parliament vote clears way for new EU clinical trial rules
This article was originally published in Scrip
Executive Summary
On 2 April, the European Parliament 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 consent. 594 MEPs voted for the legislation, with 17 against and 13 abstentions.