EU drug regulators agree common approach to data transparency

The European Medicines Agency (EMA) and Heads of Medicines Agencies (HMA) 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 commits 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.

The initial guidance was adopted in 2012, marking the first time European regulatory authorities agreed a consistent approach to identifying which parts of an application dossier can or cannot be released to the public.

The revised guidance on CCI aims to align with day-to-day practice and to ensure all authorities continue to follow a harmonised approach.

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, the EMA and HMA said in a statement.