EMA's pioneering policy entered into force on 1 January 2015 and applies to clinical reports contained in all marketing-authorisation applications submitted on or after this date. The first reports are currently foreseen to be publicly available in September 2016.
"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."
The guidance consists of four chapters.
The first is an overarching introduction with information on the scope and definitions used throughout the text. The second chapter details procedural aspects on the submission of clinical reports including the concrete processes.
The third chapter gives guidance to companies on how to anonymise clinical reports for the purpose of publication. EMA recognises that a number of methods are available to make sure the data is presented in a form that does not allow re-identifying individuals who have participated in clinical trials. Therefore the guidance does not single out one specific anonymisation method yet 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 to the anonymisation of the data, which will be reviewed and published by EMA.
The fourth chapter focuses on the identification and redaction of commercially confidential information (CCI) in clinical reports submitted to EMA for the purpose of publication. The guidance makes clear that the vast majority of the information contained in clinical reports is not considered CCI. However, in the limited circumstances in which clinical reports might contain CCI, companies will need to submit to EMA for review a table justifying why such 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.
This detailed set of guidance has been finalised following an extensive consultation with all stakeholders concerned throughout 2015.
To further ensure that companies are well prepared for the proactive publication of clinical data, EMA will now start reaching out to companies which are concerned by the first wave of publication, i.e. those for which the decision-making process has been finalised since the policy entered into force. In addition, EMA will organise a webinar in the second quarter of 2016 to allow companies to ask any outstanding practical questions. This webinar will be live broadcast and will be available for future reference on the EMA website.
External guidance on the implementation of the European Medicines Agency policy on the publication of clinical data for medicinal products for human use