Reference guides to the key procedures and requirements for pharmaceutical assessment and market access in France.
France HTA Guide09/30/2026
The HAS submission (soumission HAS) is a central step in the assessment of a medicine for standard reimbursement in France. The Transparency Committee (Commission de la Transparence, CT) of the Haute Autorité de Santé (HAS) assesses, in particular, the medical benefit (Service médical rendu, SMR), the therapeutic improvement over existing alternatives (Amélioration du service médical rendu, ASMR), and the target population relevant for reimbursement. This assessment is distinct from the regulatory benefit-risk assessment performed as part of the marketing authorisation process.