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Published on 1 May 2013

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Modernised clinical trial regulation

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Commenting on the interim ruling of the General Court of the European Union preventing the European Medicines Agency (EMA) from providing documents as part of two access-to-documents requests until a final ruling is given by the Court, Steve Bates, BioIndustry Association (BIA) Chief Executive Officer, said:
“The interim ruling must not delay the timetable for introducing a modernised Clinical Trial Regulation for Europe.
 
“Additionally, the BIA and its members have played an active role in the five advisory groups set up to inform the agency on specific aspects of its policy on proactive publication of data from clinical trials and welcome today’s publication of the final advice and looks forward to contributing to the consultation on the EMA draft policy.”


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