New EU Trial Regs Closer to Reality with CTIS Launch Date Set
The EU’s new Clinical Trial Regulation (CTR) is closer to taking effect now that the European Medicines Agency (EMA) has set a target launch date of December 2021 for its oft-delayed Clinical Trials Information System (CTIS).
The EMA planned to implement the regulation once the CTIS was fully functioning, but technical issues have repeatedly postponed the system’s launch. The EMA has initiated an independent audit of the system’s functionality that is still ongoing.
The agency says it plans to review and then confirm the audit’s findings to ensure the usability, quality and stability of the system, which was previously scheduled for a September 2018 rollout. The CTR, which was first approved by the EU in 2014, will ultimately take effect six months after the European Commission publishes a notice of the EMA’s confirmation of the CTIS.