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Posted 17 July 2012 | By Louise Zornoza,
The European Commission has issued a proposal to revamp the rules governing clinical trials. The proposed legislation will replace the "Clinical Trials Directive" of 2001, and will take the form of a regulation, ensuring that the rules for conducting clinical trials are identical throughout the EU.
In particular, it will make it easier to conduct multinational clinical trials in Europe. Some concrete proposals are:
The legislative proposal will now be discussed in the European Parliament and in the Council. It is expected to come into effect in 2016.
Revision of the Clinical trials Directive
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Tags: CTD, Clinical Trials Directive, Latest News, regulation, clinical trials
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