EU Clinical Trial System Launch Delayed To Jan 2022

The European Medicines Agency’s management board has agreed a revised go-live date for the new clinical trial information system. The new date is 'aspirational' and might change again depending on how the system fares in an ongoing independent audit to ascertain its full functionality.

Business, Technology, Internet and network concept. Business man working on the tablet of the future, select on the virtual display: Clinical trial
CTIS will overhaul the management of clinical trial processes in the EU • Source: Shutterstock

The much-awaited launch of the EU Clinical Trial Information System (CTIS) has been delayed again, this time until 31 January 2022, to allow time for a range of activities that still have to be undertaken before the system goes live.

The CTIS was expected to become functional in December 2021, clearing the way for the implementation of the EU Clinical Trial Regulation (No 536/2014). (Also see "EU Clinical Trials...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Pink Sheet for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required

More from Clinical Trials

US FDA’s Prasad: ‘We Will Always Embrace Surrogate Endpoints’

 

The new CBER director, once best known in the pharma world for criticizing accelerated approval, committed to expediting cancer drugs with surrogate endpoints.

UK And US Regulators In Sync On RWD External Control Arms

 
• By 

The UK regulator’s draft guideline on the use of external control arms based on real-world data reflects concepts similar to those outlined by the US Food and Drug Administration.

EU To Track Decentralized Clinical Trials In CTIS To Support Innovation

 
• By 

Monitoring the use of decentralized elements in clinical trials is a priority for the European medicines regulatory network.

More from R&D

EU To Track Decentralized Clinical Trials In CTIS To Support Innovation

 
• By 

Monitoring the use of decentralized elements in clinical trials is a priority for the European medicines regulatory network.

Pink Sheet Podcast: US FDA’s Big Vaccine Policy Week

Pink Sheet reporter and editors discuss the new clinical trial requirements that the FDA announced for COVID-19 vaccines, the updated label for Novavax’s newly approved COVID-19 vaccine, and other vaccine-related events that were part of a busy week for policy in the sector.

ICH Targets RWE, Rare Diseases, Biosimilars, ATMPs In New Guideline Push

 
• By 

The International Council for Harmonisation has identified four new topics that can benefit from global regulatory alignment, with timelines for initiating work to be determined later.