The draft Regulation on clinical trials, which is intended to replace the Clinical Trials Directive, will take its next step through the EU’s legislative process later this afternoon, when it is debated and voted upon by members of the Committee on the Environment, Public Health and Food Safety.
The committee issued a draft report on the proposal in January, and over 700 amendments have been proposed so far. The session included votes on many of the individual amendments, along with groups of consolidated and compromise amendments. At this time, it is unclear which measures have been amended, but a revised text should be issued shortly.
A summary of the Regulation’s progress can be found here.
The session can be watched on demand via http://www.europarl.europa.eu/ep-live/en/committees/video?event=20130529-1500-COMMITTEE-ENVI.
If approved at this stage, the proposed Regulation will go before the full Parliament on October 8th 2013.