The European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) have announced a significant update to their guidance on identifying commercially confidential information (CCI) and personal data in marketing authorization applications for human medicines. The update reflects over a decade of experience in handling access-to-documents requests and aligns with evolving transparency practices.

The updated guidance reaffirms that the majority of data in marketing authorization applications is not considered CCI. Instead of applying a 'yes/no' rule for releasing entire sections of the dossier, the new approach assumes information is releasable by default, simplifying the process of determining what can be shared. Exceptions primarily concern information about manufacturing processes, facilities, equipment, and certain contractual arrangements.

One of the most significant changes is that general information related to quality, which was previously classified as CCI, is now mostly considered releasable. This is despite requests from the industry to broaden its confidentiality and even consider the entire Module 3 as CCI.

On various occasions, the guidance puts more emphasis on the fact that only “detailed information” will be considered CCI. For example, “detailed information on contractual agreements”, or “detailed data concerning the active substance, formulation, manufacturing, test procedures and validation”.

The annex of the guidance document has been updated to include more specific examples of information that may be considered CCI. For example, for biotechnology products, it is reaffirmed that a general description of the active ingredient and producer cell type is not considered CCI. In the initial guidance, details of the process, cell banks, fermentation, and purification processes could have been considered confidential in certain circumstances. The new guidance now provides which information of such details exactly may be considered CCI, i.e. Master Virus Seed (MVS), Master Seed Lot (MSL), and Master Transgenic Bank (MTB).