Protecting CCI And Partnership Submissions For EMA’s Clinical Data Publication Policy

A senior Janssen official explains how companies should prepare documents to ensure information that they believe is commercially confidential is protected under the European Medicines Agency’s clinical data publication policy and looks to some of the challenges they may face when it comes to drugs developed in a partnership.

Redacted — The EMA has rejected the majority of proposed redactions for CCI • Source: Shutterstock

The safest way for drug companies to ensure the European Medicines Agency does not publish commercially confidential information that they believe their clinical study reports might contain is to not include the information in the first place.

That may seem obvious but this was the advice Janssen’s Stephen Bamford had for companies, some of whom have been...