MEDICINES : CLINICAL TRIALS: DOCTORS VOICE CONCERNS.
The proposal for revision of the directive on clinical trials - COM(2012)0192 - initially welcomed by stakeholders, now seems to be creating concerns for some. The Standing Committee of European Doctors (CPME) regrets the total absence of ethical considerations in the text.
The long-awaited proposal - which repeals Directive 2001/20/EC - was presented on 17 July 2012. In fact, stakeholders are virtually unanimous in their objections to the 2001 directive. Patients' associations, pharmaceutical firms and researchers criticise it for imposing too cumbersome a regulatory framework...
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