The European Medicines Agency (EMA) has published new guidance for pharmaceutical companies on how to comply with its new policy on the publication of clinical data.
The policy, which entered into force on 1 January 2015, applies to clinical reports contained in all marketing authorization applications (MAAs) submitted on or after this date and the reports will be made publicly available in September 2016.
The 91-page guidance document features four chapters, including an introduction on its scope, procedural aspects on the submission of clinical reports, how to anonymize the reports for publication, and how to identify and redact commercially confidential information (CCI).
EMA notes that for MAAs, line extension applications and extension of indication applications, EMA will publish the redacted/anonymized clinical reports within 60 days of the issuance of the EC decision. For withdrawn applications, the publication of the redacted/anonymized clinical reports will take place within 150 days after the receipt of the withdrawal letter.
"With this guidance, the agency is moving towards the operational implementation of its proactive publication policy, which launched a new era of transparency," says Noël Wathion, EMA's deputy executive director. "The guidance will ensure that companies are aware of what is expected of them and are ready for the publication of these critical data."
As far as anonymizing reports, EMA said it does not single out one specific method but gives recommendations to companies on how to best balance data utility for researchers with a minimal risk of re-identification. Companies will need to provide a report explaining their approach, which will be reviewed and published by EMA.
The guidance also makes clear that the vast majority of the information contained in clinical reports is not considered CCI and that in the limited cases in which clinical reports might contain CCI, companies will need to submit for EMA review a table justifying why data has been redacted. The guidance clarifies which type of data EMA would typically refuse as being CCI and how the redaction of such data will be handled.
To further ensure that companies are well prepared for the proactive publication of clinical data, EMA says it will now start reaching out to companies concerned by the first wave of publication. In addition, EMA will organize a webinar in Q2 of 2016 to allow companies to ask any outstanding practical questions.
For the past five years EMA has allowed academic researchers and journalists to access the anonymized trial reports, though as a recent study shows, the system is slowly improving.
External guidance on the implementation of the European Medicines Agency policy on the publication of clinical data for medicinal products for human use