Malte Scheel Dr. Tobias Maier July 13 2022 European Medicines Agency consults on draft guidance relating to data protection in clinical trials Eversheds Sutherland (International) LLP | Healthcare & Life Sciences - European Union Malte Scheel, Dr. Tobias Maier Healthcare & Life Sciences The European Medicines Agency has published draft guidance on the protection of personal data and commercially confidential information in the Clinical Trial Information System (CTIS) for consultation, which will end on 8 September 2022.The EU Clinical Trials Regulation(1) was introduced to increase the availability of information regarding clinical trials, including their results. It facilitated the establishment of the EU Clinical Trials Portal and Database, both of which are important to ensure transparency of clinical trials and associated information and serve as a source of public information on clinical trials.While the EU Clinical Trials Regulation aims to increase transparency, it also sets out requirements in relation to personal data and commercially confidential information. The guidance focuses on the following:the CTIS structure, including a description of the functionalities and publication rules for clinical trials information uploaded to CTIS;the protection and management of personal data, including anonymisation and pseudonymisation;the protection of commercially confidential information; andthe protection of personal data and commercially confidential information in inspection reports.For further information on this topic please contact Malte Scheel or Tobias Maier at Eversheds Sutherland LLP by telephone (+49 89 54565 0) or email ([email protected] or [email protected]). The Eversheds Sutherland LLP website can be accessed at www.eversheds-sutherland.com.Endnotes(1) No. 536/2014.