EMA, HMA Release Joint Guidance Document on Commercially Confidential Information in MAAs

The European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) announced 27 March they have adopted a joint guidance document that will provide a "consistent Europe-wide approach to the identification of commercially confidential information and personal data in a marketing authorization application."

"In [the] future, regulatory authorities in the European Economic Area (EEA) will apply the same principles to identify which parts of an application dossier can or cannot be released in response to access to documents requests," the agencies wrote. "This is regardless of whether the medicine concerned has been authorized using the centralized, mutual recognition or decentralized procedures."

The guidance will limit what information will be considered commercially confidential by regulators, with exceptions being granted for information about quality, manufacturing, facilities, equipment and contractual arrangements. Further, the document will protect any personal data that could lead to the identification of a person, and provides instruction on how to redact such information.

The guidance document-HMA/EMA Guidance document on the identification of commercially confidential information and personal data within the structure of the Marketing Authorisation (MA) Application - release of information after the granting of a Marketing Authorisation-should be interpreted jointly with a second guidance document, Principles to be applied for the implementation of the HMA/EMA Guidance on the identification of CCI and PPD in MA Applications.

Read more:

EMA - European medicines regulators agree a common, Europe-wide approach for the identification of commercially confidential information and personal data

EMA/HMA - Principles to be applied for the implementation of the HMA/EMA Guidance on the identification of CCI and PPD in MA Applications