EU Clinical Trial Regulations - The Latest Updates
In January the European Parliament's committee responsible for public health voted in favour of a revised version of the EU Clinical Trial Regulation initially proposed by the European Commission in July 2012.
This paves the way for formal adoption of the regulation by the European Parliament and Council of the EU in 2014.
The European Commission (EC) has released a new draft EU aimed at reforming the EU clinical trials regulations, dismantling an earlier attempt to modernize the rules and instead instituting an EU-wide harmonized approach.
The European Commission is going to entirely replace the Clinical Trial Directive in light of widespread criticism from “patients, researchers and industry alike.” Of particular concern was the lack of harmonization between countries and the high costs of complying with the directive. This has contributed to a significant decline of clinical trials in the EU,” wrote the commission. “Between 2007 and 2011 the number of clinical trials conducted in the EU fell by 25%. This new single regulatory proposed framework will allow the pharmaceutical industry to avoid the current “patchwork” of national frameworks.
The new proposed legislation will immediately affect an enormous amount of clinical research and it will be critically important to understand the new requirements.
It is suggested the new regulation will have a significant impact on how to conduct multinational clinical trials in Europe because it provides for:
- An authorisation procedure for clinical trials which will allow for a fast and thorough assessment of the application and which will ensure one single assessment outcome
- Simplified reporting procedures
- More transparency on whether recruitment for participating in a clinical trial is still ongoing and on the results of the clinical trial
The ability for the commission to conduct controls to make sure the rules are being properly supervised and enforced.
The EU Health Commissioner Tonio Borg said the revised rules "will ensure that the EU remains an attractive location for clinical research (2013). However, there are significant concerns remaining about how the proposed legislation will impact on audit and inspection.
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