EMA releases new guidance on clinical data publication

The European Medicines Agency (EMA) has published detailed guidance on how pharmaceutical firms can comply with its new policies on publishing clinical data.

The rules came into force in January 2015 and apply to clinical reports contained in all marketing authorisation applications submitted from this date. The first release of such reports is planned for this September (2016).

The guidance explains legal definitions and procedures for submitting clinical reports. It also advises companies on anonymising clinical reports for publication, balancing data utility for researchers and minimising the risk of identifying data subjects.

EMA also advises on identifying and redacting commercially confidential information in clinical reports. The advice notes that companies have to submit a table justifying redactions and what kind of redactions EMA may refuse.

'With this guidance, the Agency is moving towards the operational implementation of its proactive publication policy, which launched a new era of transparency,' said Noël Wathion, EMA's Deputy Executive Director.