EMA and HMA (Heads of Medicines Agencies) have published a comprehensive overhaul of their guidance on the identification of commercially confidential information (CCI) and personal data in marketing authorisation applications for human medicines. The update reaffirms the commitment of regulatory authorities across the European Economic Area (EEA) to extensive transparency when disclosing information, both in response to access-to-documents requests and in the proactive publication of data once a medicine is authorised.
With the adoption of the initial guidance in 2012, European regulatory authorities agreed for the first time a common and consistent approach to identifying which parts of an application dossier can or cannot be released to the public, regardless of whether the medicine concerned has been authorised using the centralised, mutual-recognition or decentralised procedures.
Since then, EMA and the national competent authorities have gained experience in handling access-to-documents requests and over the years, they have applied further transparency when releasing data. This made it necessary to review the guidance on CCI to align it with day-to-day practice and to ensure all authorities continue to follow a harmonised approach. The principles applied in the context of EMA’s proactive clinical data publication, launched in 2014, are also reflected in the updated guidance.
As a general rule, the overwhelming majority of data in marketing-authorisation applications is not considered CCI. The exceptions mainly relate to information about the manufacturing of a medicine, as well as information about facilities or equipment and some contractual arrangements between companies. While considered CCI at the time of the initial guidance, general information related to quality is now mostly considered releasable.
Instead of applying a ‘yes / no’ rule as to whether an entire section of the dossier can be released, the updated guidance considers information as releasable by default. It provides detailed practical orientations as to which specific points could be redacted or anonymised within each section of the dossier. The annex of the guidance document has been updated and now includes examples of information that may be considered CCI or protected personal data.
The guidance also sets out how personal data will be protected if it can lead to the identification of a person. In doing so, it now considers the more recent EU legislation on data protection, namely the EU General Data Protection Regulation (GDPR) and Data Protection Regulation for the European Union institutions, bodies, offices and agencies (EUDPR). The document gives further guidance on how to identify personal data relating to experts, staff or patients, which should be anonymised.
The guidance document was released for public consultation from 12 April to 28 June 2024. Nine companies, associations and other organisations sent comments, generally welcoming the HMA / EMA initiative and the efforts to promote a more transparent and consistent approach across the network. A report with the analysis from the public consultation will be published at the beginning of 2025.
This guidance applies to medicinal products for human use. It can be applied by analogy to veterinary medicines, until EMA and HMA have developed similar detailed guidance for veterinary medicines, which is planned for 2025.