The European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) have released a comprehensive update to their guidance on identifying commercially confidential information (CCI) and personal data in marketing authorisation applications for human medicines. This revision reaffirms the commitment of regulatory bodies across the European Economic Area (EEA) to greater transparency, both in response to document access requests and in the proactive release of data following the authorisation of a medicine.

Initially introduced in 2012, the original guidance marked the first unified approach by European regulatory authorities to determining which parts of an application dossier could be disclosed to the public, irrespective of whether the medicine was authorised through the centralised, mutual-recognition, or decentralised procedures. Over time, EMA and national competent authorities gained valuable experience handling access requests, which led to a broader approach to transparency in releasing data. As a result, it became necessary to update the guidance to align with current practices, ensuring all authorities continue to adopt a consistent approach. The guidance includes minor revisions from a draft released in March 2024.
Rather than a simple ‘yes/no’ determination regarding the release of an entire dossier section, the new guidance adopts a more nuanced approach. It assumes that information is releasable by default, providing detailed guidance on what specific information may need to be redacted or anonymised. The annex of the guidance has also been updated to offer examples of what constitutes CCI or protected personal data.
Regarding personal data, the guidance includes measures to ensure compliance with the latest EU data protection laws, including the General Data Protection Regulation (GDPR) and the Data Protection Regulation for EU institutions, bodies, offices, and agencies (EUDPR). It also outlines the procedures for anonymising personal data linked to experts, staff, or patients.
The revised guidance was open for public consultation from 12 April to 28 June 2024. Nine companies, associations, and other organisations provided feedback, generally expressing support for the EMA/HMA initiative and the push for a more transparent and consistent approach across the network. A report summarising the consultation’s findings will be published in early 2025.
This updated guidance applies to human medicinal products and may be applied by analogy to veterinary medicines until similar detailed guidance for veterinary products is developed by EMA and HMA, which is expected in 2025.
At Masuu Global, we provide expert services in navigating these regulatory updates to ensure your compliance with evolving standards.
Reference: https://www.ema.europa.eu/en/news/common-eu-approach-data-transparency-medicine-regulation