The document – published on March 2 – details how drug firms should submit clinical reports, how they should make patient-level data anonymous and when they can ask for commercially confidential information to be redacted.
Clinical trial data redaction is a controversial subject. The agency has faced both challenges from companies concerned sharing data would benefit rivals and criticism from European Ombudsman Emily O’Reilly about information it has allowed to be omitted to date.
In the guidance the EMA stresses that “the vast majority of the information contained in clinical reports is not considered CCI (commercially confidential information).” It also warned that drugmakers should not routinely make redaction requests every time the submit a study.
Instead, the agency said “redaction proposals based on grounds of CCI must be backed up by the applicant/MAH with a specific and clear justification.”
The justification must specify the precise information, set out how it is innovative and “explain how the disclosure of the information concerned would undermine the applicant’s/MAH’s legitimate economic interest.”
Drug companies will not be able to seek redactions for information that is already publically available, common knowledge or if its publication is in the public interest.
The first set of reports is due to be published in September 2016.
Drug industry group EFPIA told us: "We welcome the publication of the guidance by the EMA, as this now clarifies expectations of companies and allows them to progress activities to implement EMA’s Policy 0070.
"We also welcome the fact that EMA has taken on board some of the feedback provided by industry during its consultations in 2015, such as allowing companies some flexibility in the format of presentation of redacted clinical study reports.
EFPIA added that: "As is acknowledged in the guidance, this is a new undertaking: the initial operational implementation will be a learning process, so we can expect that challenges and questions will arise. We look forward continued cooperation with the EMA to ensure that their Policy is implemented in the most efficient manner."