Ask the Expert: EU Data Protection

The European Medicines Agency (EMA) announced in December 2024 that the agency and the Heads of Medicines Agencies (HMA) have revised their guidance on identification of commercially confidential information (CCI) and personal data used in marketing authorization applications. The revision was done as part of the agency’s commitment to transparency in the disclosure of information in response to access-to-document requests and the publication of data for authorized medicines (1).

In this episode of the Ask the Expert video series, Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, and Siegfried Schmitt, PhD, vice president, Technical at Parexel, discuss the impact of the revised guidelines and what manufacturers should do to secure such data.

“It was always felt that one should not have concerns when sending anything to the agencies such as the European Medicines Agency, or any agency within the European Union or the European Economic Area, because you would think that they understand what is confidential and what is not; however, this document is really a wakeup call, as the agencies only feel obliged to not disclose anything that is blindingly obvious secret, such as the manufacturing formula,” Schmitt says.

“So, this is completely different to what most companies had in the back of their mind. There are perhaps less obvious data in an application that could potentially cause enormous harm to the applicant if they were disclosed. For example, the listing of the clinical study sites and the names and contact details of the principal investigators; competitors could try and poach the patients and/or the investigators. The guidance only says that such data and information may be considered secret, but it doesn't say it is secret,” Schmitt explains.

Click the video above to watch Sue and Siegfried answer the following question:

“Our company handles a variety of personal data in our regulatory applications, and we saw that EMA has revised guidelines on the use of personal data in applications. What should we focus on when securing these data?”

Reference

1. EMA. A Common EU Approach to Data Transparency in Medicine Regulation. Press Release. Dec. 18, 2024.

About the experts

Susan J. Schniepp is distinguished fellow at Regulatory Compliance Associates and a member of Pharmaceutical Technology®'s Editorial Advisory Board.

Siegfried Schmitt is vice president, Technical at Parexel and a member of Pharmaceutical Technology®'s Editorial Advisory Board.

Ask the Expert Video Series

Welcome to the Ask the Expert video series. This series is an extension of the PharmTech Group’s long-running print column in which industry experts answer common quality and regulatory questions from the industry. This new video series will expand on topic areas to include development and manufacturing concerns to help those working in the industry better understand bio/pharmaceutical requirements. Have a question you would like answered? Send it to PTProjects@mmhgroup.com, and it may appear in a future episode or print column.

We hope you enjoy the discussion!