On July 17, 2012, the European Commission ("EC") adopted a proposal that would significantly simplify the current framework relating to clinical trials in Europe. This proposal is not yet final as it must be reviewed by the European Council and European Parliament (both of which might make changes), and it is not likely to be implemented before 2016. The EC proposes to replace the current Clinical Trials Directive with a regulation. Under EU law, regulations automatically apply to all Member States immediately, unlike directives, which require the passage of individual national laws for implementation.
The proposed regulation would eliminate the "otherwise significant" category of post-authorization modifications requiring approval, and establish only two categories: those affecting the safety or rights of the subjects and those dealing with the reliability and robustness of the data. In addition, the proposed regulation provides for a single application submitted to the Commission. The application would be assessed jointly by all the Member States, but a single "reporting Member State" would render the decision as to acceptability (with each Member State assessing the ethical and local aspects individually). This move toward simplification and uniformity promises to increase the clinical research in Europe and advance the state of medical research generally. For more, see here.