The EU regulation aimed at harmonizing clinical trial review processes in the bloc has opened up the possibility for some countries to entice companies to conduct clinical studies in their jurisdictions by offering a faster assessment than the statutory timelines specified in the regulation, Sean Russell, head of regulatory affairs at Fondazione Telethon has warned.
EU Clinical Trials Regulation Failing To Harmonize Requirements, But UK Has ‘Great Opportunity’
The Clinical Trials Regulation was “supposed to harmonize” requirements in the EU, but instead it is giving some countries the chance to get ahead by offering faster approval timelines, notes Telethon’s head of regulatory affairs.
