EMA Rejects 76% Of Requests To Label Info In Clinical Reports As Commercially Confidential

13 Feb 2018

Most of the proposals by companies to redact commercially confidential information in their clinical study reports under the European Medicines Agency’s policy on proactive publication of clinical trial data have been rejected. Meanwhile, the agency is planning to make improvements to the policy this year.

Protection — In Many Cases, Information Proposed As CCI Was Already Publicly Available • Source: Shutterstock

The European Medicines Agency has rejected 76% of the proposals by pharmaceutical companies to redact what they claimed was commercially confidential information (CCI) in their clinical study reports under the agency's landmark policy on the proactive publication of clinical trial data.

The most common reason for these rejections was that either the information was already available in the public domain or...