18 December 2024 – The European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) have published a comprehensive update to their guidance on the identification and disclosure of commercially confidential information (CCI) and personal data in marketing authorization applications for medicinal products. The update reaffirms the commitment of regulatory authorities across the European Economic Area (EEA) to extensive transparency in the disclosure of information, both in response to access-to-documents requests and in the proactive publication of data once a medicinal product is authorized. The revised guidance aligns with the principles of the EMA's clinical data publication initiative launched in 2014 and ensures that all regulatory authorities across the EEA follow a harmonized approach.

The new guidance emphasizes that the majority of data in marketing authorization applications is not considered CCI, with exceptions mainly related to information on the manufacturing of a medicinal product, as well as information on facilities and certain contractual arrangements. General information related to quality, which was previously considered CCI, is now largely deemed releasable. The guidance adopts a flexible, detailed approach to reviewing the content of each document, with information being considered releasable by default unless there are valid reasons for anonymization or redaction.

Additionally, the new guidance considers the latest data protection regulations of the European Union (EU), particularly the General Data Protection Regulation (GDPR), and provides detailed instructions on how to identify and anonymize personal data of experts, staff, or patients to ensure privacy protection. The guidance was publicly consulted in the second quarter of 2024, and an analysis of the feedback will be published in early 2025.

For more information, see here.