Update on the EMA Guidance on Protection of Personal Data & CCI

Monoclonal Antibodies - From Concept to Approval

Recommendation

20/21 May 2025
Vienna, Austria

Monoclonal Antibodies - From Concept to Approval
With a workshop about the development of ADCs

The European Medicines Agency (EMA) plans to gradually resume clinical data publication from September 2023, having temporarily suspended this activity. Therefore, the EMA has revised and supplemented the previously published documents on the transfer of personal data and commercially confidential information (CCI) through the CTIS. The following documents have been published:

Updated Guidance document (final version) on how to approach the protection of personal data and commercially confidential information while using the Clinical Trials Information System (CTIS) version 1.1
Updated Annex I - Guidance document on how to approach the protection of personal data and commercially confidential information while using the Clinical Trials Information System (CTIS) version 1.0
New Annex II - Guidance document on how to approach the protection of personal data and commercially confidential information while using the Clinical Trials Information system (CTIS). The template applies to Good Clinical Practice (GCP) inspections carried out to category 1 trials (i.e., pharmaceutical development clinical trials, e.g. Bioequivalence Study) where the publication of clinical trial information is delayed by a deferral.

More information is available on EMA´s Support for industry on clinical data publication and Clinical Trials Information System: training and support Websites.