A complete revision guidance on the identification of commercially confidential information (CCI) and personal data in marketing authorisation applications for human medicines was published in December 2024 by EMA and HMA (Heads of Medicines Agencies). The initial guidance was released in 2012. Extensive transparency when disclosing information, both in response to access-to-documents requests and in the proactive publication of data once a medicine is The revision is based on the experience EMA and the national competent authorities have gained over the years.
The new guidance on CCI aligns with current practices, ensures a harmonised approach across all authorities, and reflects the principles applied in the context of EMA’s proactive clinical data publication. As a general rule, the great majority of MAA’s data is not considered CCI. Exceptions may refer to information about manufacturing, facilities or equipment and some contractual arrangements between companies. According to the updated guideline, general information related to quality is now mostly considered releasable. It also provides an indication of how personal data will be protected if it can lead to the identification of a person, as for the GDPR and EUDPR.