The draft EU Clinical Trial Regulation is scheduled for a vote in the plenary session of the European Parliament on April 4th, following a plenary debate on April 2nd.
UPDATE (April 2nd): The European Parliament website now forecasts that the vote is expected to take place earlier, on April 3rd, while transparency lobby group AllTrials has contacted followers saying that it has information that the vote will, in fact, take place today, April 2nd, following the plenary debate.
This is a crucial landmark in the adoption of the Regulation, which will then be phased in to replace current provisions governing clinical research throughout Europe. The use of a Regulation, rather than the current Directive, is important as this means identical rules will apply across the EU, rather than the current “harmonised” approach, which is widely acknowledged to be far less harmonised than was originally intended.
Behind the scenes, the proposed text to be put before the plenary session was agreed in January 2014. Pharmaceutical trade body EFPIA broadly welcomed the text, but reiterated concerns that “some of the initial objectives of the legislation have been only partially achieved; therefore the success of this legislation strongly depends on how it will apply in practice.“