Clinical Trials Regulation: a step in the right direction?
By Thomas Hendicott
On 2 April 2014, the European Parliament voted in favour of the implementation of a new Clinical Trials Regulation (‘Regulation’). This will revoke the current Clinical Trials Directive 2001/20/EC (‘Directive’) and will have a significant impact for companies engaged in clinical trial activities in the EU. It is anticipated that the Regulation will provide a welcome boost for European research and development, resulting in tangible health benefits and economic growth, including a predicted saving of €800m (£660m) per year in regulatory costs. However, it is essential that it is interpreted and applied in a way that respects both patient privacy and commercially confidential information. This article presents a brief synopsis of the major changes and the impact of these changes for pharmaceutical companies running clinical trials in the EU.
The most notable changes to be introduced under the Regulation can be summarised as follows:
The introduction of a Regulation, as opposed to a Directive, means that its provisions will be directly effective in all member states. The Regulation will be binding in its entirety and automatically incorporated into the national laws for all EU member states…
Click on the link below to read the rest of the Bristows briefing.
Sign in or Register to continue reading this article
It's quick, easy and free!
It takes just 5 minutes to register. Answer a few simple questions and once completed you’ll have instant access.Register now
Why register to The Lawyer
In-depth, expert analysis into the stories behind the headlines from our leading team of journalists.
Identify the major players and business opportunities within a particular region through our series of free, special reports.
Receive your pick of The Lawyer's daily and weekly email newsletters, tailored by practice area, region and job function.
More relevant to you
To continue providing the best analysis, insight and news across the legal market we are collecting some information about who you are, what you do and where you work to improve The Lawyer and make it more relevant to you.
News from Bristows
News from The Lawyer
Briefings from Bristows
The High Court has held that in certain circumstances the European Insolvency Regulations 1346/2000/EC may effectively extend the jurisdictional reach of the English courts.
A recent decision may result in a potentially more expansive basis for establishing jurisdiction over defendants in Europe.