What is the regulatory body of pharma in France?

The main regulatory authority for pharmaceuticals in France is the ANSM (Agence nationale de sécurité du médicament et des produits de santé). It oversees drug approval, safety, pharmacovigilance, and market supervision. For health technology assessment and reimbursement decisions, the competent body is the HAS (Haute Autorité de Santé).

Pricing negotiations are handled by the CEPS (Comité économique des produits de santé).

The URSSAF oversees social security contributions and employer obligations, but it is not directly involved in the regulatory pathway of a medicinal product.

Sources

• ANSM – https://ansm.sante.fr
• HAS – https://www.has-sante.fr
• CEPS – Comité économique des produits de santé – CEPS – Ministère du Travail, de la Santé, des Solidarités et des Familles
• URSSAF – Accueil – Urssaf.fr