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.
Brief
On April 12, 2024, EMA and HMA published an updated guidance on identifying commercially confidential information (CCI) and personal data in marketing authorisation applications for human medicines. The revised guidance aims to promote a more transparent and consistent approach across the European Economic Area (EEA), with the majority of data in marketing-authorisation applications considered releasable, subject to specific exceptions related to manufacturing and contractual information.
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Purpose:
The EMA and HMA have published an updated guidance on identifying commercially confidential information (CCI) and personal data in marketing authorisation applications for human medicines. This overhaul aims to ensure a consistent and harmonised approach across European regulatory authorities, reaffirming their commitment to transparency in disclosure of information.
This update is a comprehensive revision of the initial guidance adopted in 2012, which introduced a common approach to identifying parts of an application dossier that can or cannot be released to the public. The new guidance takes into account experience gained since its adoption and aligns with day-to-day practice, ensuring 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. This reaffirms the commitment of regulatory authorities across the European Economic Area (EEA) to transparency when disclosing information, both in response to access-to-documents requests and in the proactive publication of data once a medicine is authorised.
The updated guidance provides detailed practical orientations as to which specific points could be redacted or anonymised within each section of the dossier. This ensures that information can be released by default, with only exceptions related to manufacturing, facilities, equipment, and some contractual arrangements between companies being considered CCI.
Effects on Industry:
The updated guidance will have a significant impact on pharmaceutical companies operating in Europe, as they must adapt their practices to align with the new principles. The majority of data in marketing-authorisation applications is not considered CCI, but exceptions mainly relate to manufacturing information and contractual arrangements between companies.
Pharmaceutical companies will need to review and update their approaches to identifying CCI and personal data, ensuring compliance with the updated guidance. This may involve changes to their documentation and disclosure practices, potentially affecting business operations and resource allocation.
The updated guidance also sets out how personal data will be protected if it can lead to the identification of a person, considering recent EU legislation on data protection, namely the GDPR and EUDPR. This ensures that companies handle personal data in accordance with these regulations.
Relevant Stakeholders:
Pharmaceutical companies operating in Europe, as well as experts, staff, and patients involved in clinical trials or medication development, are directly affected by this update. Companies will need to adapt their practices to align with the new principles, while individuals may have their personal data protected under the updated guidance.
Regulatory authorities across the European Economic Area (EEA), including EMA and national competent authorities, will also be impacted as they implement the updated guidance. These authorities are committed to transparency in disclosure of information, ensuring a harmonised approach across Europe.
Next Steps:
Pharmaceutical companies operating in Europe must review and update their practices to align with the new principles outlined in the updated guidance. This may involve changes to documentation and disclosure practices, potentially affecting business operations and resource allocation.
Companies should also ensure compliance with recent EU legislation on data protection, namely the GDPR and EUDPR, when handling personal data.
Regulatory authorities across Europe will implement the updated guidance, ensuring a harmonised approach to identifying CCI and personal data in marketing-authorisation applications for human medicines.
Any Other Relevant Information:
The updated guidance 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 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. The guidance document applies to medicinal products for human use but can be applied by analogy to veterinary medicines until EMA and HMA develop similar detailed guidance, planned for 2025.
