New Guidance To Clarify Transparency Provisions In EU Clinical Trials Portal

20 Jan 2023

EU regulators have developed new guidance to help companies steer through the transparency requirements in the Clinical Trials Information System and protect personal and commercially confidential information in submissions.

Closed up finger on keyboard with word CLINICAL TRIALS — Improved Transparency Is A Key Milestone Of The EU Clinical Trials Regulation • Source: Shutterstock

EU regulators have finalized a highly anticipated Q&A document to further clarify the existing transparency provisions applicable to studies submitted for approval under the Clinical Trials Regulation via the Clinical Trials Information System (CTIS).

The Q&As are expected to be published next week, Laura Pioppo of the European Medicines Agency said on 20 January...