[Ip-health] EU wants to facilitate clinical trials on humans’

Riaz K Tayob riaz.tayob at gmail.com
Mon Feb 18 06:23:10 PST 2013


  Health: ‘EU wants to facilitate clinical trials on humans’


    18 February 2013
    Presseurop
    Süddeutsche Zeitung

<http://www.presseurop.eu/files/suddeutsche-18022013_0.jpg> Süddeutsche 
Zeitung 
<http://www.presseurop.eu/en/content/source-profile/553-sueddeutsche-zeitung>, 
18 February 2013

The European Commission plans to introduce a regulation 
<http://ec.europa.eu/health/files/eudralex/vol-1/dec_2013_51/dec_2013_51_en.pdf> 
to simplify the procedure for carrying out pharmaceutical tests on 
humans 
<http://www.presseurop.eu/en/content/news-brief/2370491-eu-wants-simplify-drug-tests-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.




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