Update on the EMA Guidance on Protection of Personal Data & CCI
Recommendation
5-7 November 2024
Hamburg, Germany
GMP and FDA Compliance in Pharmaceutical Development and IMP Manufacturing
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.
Related GMP News
17.10.2024FDA's final Q&A Document on Electronic Systems & Data in Clinical Trials
17.10.2024EMA Guideline on Quality and Equivalence of Topical Products
05.09.2024Clinical Trials Regulation - Version 6.9 of the Q&As
23.07.2024Pilot Results on Regulatory-Led RWE Generation
23.07.2024ICH M12 Guideline on Drug Interaction Studies
20.06.2024Draft ICH M14 Guideline on Real-World Data for Safety Assessment