EPAR

Also known as: European Public Assessment Report

The publicly available EMA assessment of a centrally-authorised medicine.

Definition

A European Public Assessment Report (EPAR) is the EMA's published assessment of every medicine authorised via the centralised procedure. It contains the product information, scientific rationale, clinical trial data, benefit-risk balance, and post-authorisation commitments. The EPAR is the EMA equivalent of the FDA's "Summary Basis of Approval."

See also

• EMA — The EU regulatory agency that authorises and supervises medicines for use across member states.
• CHMP — The EMA committee that issues opinions on whether a medicine should be authorised in the EU.
• NDA — New Drug Application — the FDA submission required to market a new small-molecule drug in the US.
• BLA — Biologics License Application — the FDA submission required for biologics (proteins, antibodies, gene therapies).

Other regulatory terms

• NDA
• BLA
• PDUFA date
• Priority review
• Breakthrough Therapy
• Accelerated approval