FDAnews Drug Daily Bulletin
Pharmaceuticals / Research and Development

EMA Alters Guidance on Clinical Trials Data Submission Requirements

Dec. 16, 2016
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The European Medicines Agency made several changes to a March guidance explaining the agency’s policy for publishing sponsors’ clinical trials data, including factors that could lead to rejection.

The majority of changes relate to anonymization and the submitted redaction report. If an applicant submits an incomplete redaction document package — in either proposed or final forms — then the EMA will reject the entire package, which will have to be resubmitted before the original deadline.

Applicants must now color-code their redactions in the final document and distinguish between commercially confidential information and protected personal data. Additionally, any pages containing individual patient data removed from the package must be replaced by a blank page detailing the removed page numbers and section titles.

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