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EU Clinical Trials Regulation Failing To Harmonize Requirements, But UK Has ‘Great Opportunity’

 
• By Eliza Slawther

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.

From left to right: Sean Russell, Pamela Tranter, Anike Te, Miguel Forte, Salmaan Dalvi at the Advanced Therapies Congress in London, 2025 (Norstella)
Key Takeaways
  • The EU Clinical Trials Regulation has not led to greater harmonization in the EU and instead could see sponsors drawn to nations with faster trial approval timelines, a regulatory expert says.
  • A biotech CEO agreed that while the EU had the right intentions when introducing the CTR, the implementation had been challenging.
  • The UK is now in a good position to accelerate its own clinical trials landscape compared to its European counterparts.

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...

“Although the Clinical Trials Regulation (CTR) in Europe is supposed to harmonize everything, my personal experience is that it really doesn’t. You do end up still with the national requirements....

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