The European Commission plans to introduce aregulation to simplify the procedure for carrying out pharmaceutical tests on humans. The text, which will be debated in parliament in June, will dispense with the requirement for independent ethical committees to be involved in the authorisation of tests.
In future, a single member state (and more importantly, one selected by the healthcare industry) will evaluate the risks involved in trials for a particular product, and its decision will apply for all other member states. Doctors have pointed out that states with a record for imposing higher standards will be systematically circumvented, and that the constraints on human testing will be less rigorous than those that apply for animal testing.
more at http://www.presseurop.eu/en/content/news-brief/3424241-eu-wants-facilitate-clinical-trials-humans?xtor=RSS-9
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