EMA Policy 0070 and Health Canada Policy on the Public Release of Clinical Information (PRCI)

Documents within Marketing Authorisation Applications (MAAs) in the EU and Canada for new medicinal products must be made publicly available under EMAs Policy 0070 and Health Canada’s PRCI regulations. Information which allows identification of an individual must be anonymised and company confidential information must be redacted within these documents prior to public release.

Anonymisation can be achieved through redaction or redaction plus transformation approaches. Transformation requires the replacement of text within documents with information that preserves the anonymity of individuals while maintaining the scientific utility of the documents.

As part of the submission packages for Policy 0070 and PRCI, the Marketing Authorisation Holder (MAH) must submit documents that outline the approach taken to anonymise the documents (anonymisation plan) and provide a report that describes the results of the approach (anonymisation report). If company confidential information (CCI/CBI) has been redacted, then a table providing a clear justification for the redaction must also be included in the submission.

Krystelis EMA Policy 0070 and Health Canada PRCI Services

Krystelis can provide full end to end support for anonymisation of documents for Policy 0070 and PRCI. This includes contributing to, or even leading, the pre-submission meetings with the regulators that help define the anonymisation plan. For submissions that require extensive transformation of information we use a state-of-the art automated tool. You can trust our team to guide you safely and efficiently through these submissions.

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EMA Policy 0070 and Health Canada Policy on the Public Release of Clinical Information (PRCI)

Krystelis EMA Policy 0070 and Health Canada PRCI Services

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