New guidance on frequently asked questions about the publication of the Joint Clinical Assessment report

The European Commission has published a document addressing frequently asked questions about the publication of the Joint Clinical Assessment report. The guidance addresses questions including:

• What documentation, other than the procedurally compliant JCA and summary report, that have been established in the course of a specific JCA procedure will be made publicly available;

• Whether only the “core dossier” (without appendixes) will be made public;

• Whether the clinical data included in the submission file to the EMA will be published as part of JCA dossier;

• What is considered “a timely manner” for publication of the endorsed JCA report within the meaning of Article 12(4) of the HTA Regulation;

• How confidential data that might be contained in the JCA reports and JCA dossiers will be protected;

• At which point in time the health technology developer will receive the draft JCA and summary reports for the factual accuracy check and for indicating any information it considers confidential;

• Whether the Commission will inform the health technology developer ahead of the publication of the JCA report and the JCA dossier of the results of the assessment of the proposed redactions;

• What is considered commercially confidential information and could be redacted from the JCA report, the JCA dossier, and from external comments received during the preparation of the JCA report.

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