Early dialogues

HAS offers early dialogues on evidence generation plans for new pharmaceuticals, medical device or diagnostic/interventional procedure. In accordance with article L 161-37 of the French Social Security Code (CSS), only the requests meeting the eligibility criteria will be accepted, i.e., requests concerning:

• a product with a new mechanism of action in the disease, and
• targeting an indication for which there is an unmet or insufficiently covered medical need, and
• when the early dialogue can be finalized before the start of the pivotal clinical trials.

Object

Early dialogues are optional, confidential and not binding. The objective of these early dialogues is to provide companies with recommendations on clinical development and support generation of good quality evidence for proper Health Technology Assessment (HTA). Questions related to health economics can also be addressed.

The recommendations provided by HAS departments reflect the state-of-the-art of medical knowledge and national requirements at the time of the early dialogue. Therefore, they do not constitute an assessment and are not an indicator of the final appraisals reached by the National Committee of Medical Devices and Health Technologies (CNEDiMTS – Commission nationale d’évaluation des dispositifs médicaux et des technologies de santé), Transparency Committee (CT – Commission de la Transparence) and/or the Commission for Economic and Public Health Evaluation (CEESP – Commission d'évaluation économique et de santé publique). Moreover, in accordance with CSS, members of the appraisal’s committees (CNEDiMTS, CT and/or CEESP) do not participate in these early dialogues.

Early dialogues from medical devices and diagnostic/therapeutic procedures also aim to address developers’ questions regarding the clinical development of their product. They can also guide companies to anticipate which data can be expected for a special funding though the “forfait innovation” process.

Early dialogues should be distinguished from pre-submission meetings with HAS departments concerned by pharmaceuticals (clinical evaluation or health economic evaluation), medical devices or diagnostic/therapeutic procedures when the submission of the dossier is imminent.

For additional information regarding national early dialogues

Please refer to the appropriate guidances:

• For medicinal products:
  • Guidance for national early dialogues on medicinal products  
  • For more information on HAS recommendations for evidence generation on pharmaceuticals, please refer to the Transparency Committee Doctrine
• For medical devices: "Early dialogue with HAS for a medical device in clinical development "
• For diagnostic/therapeutic procedures: contact the dedicated department by e-mail (contact.seap[at]has-sante.fr)

Early dialogue at European level with the HAS

Inquiries regarding Joint Scientific Consultations (JSC) at the European level, with HAS and other HTA bodies and possibly the EMA, please contact the G-BA which is responsible for interim JSC procedures; i.e. until the HTA Regulation becomes applicable (through December 2024). As of 2025 the main contact will be the secretariat of the Coordination Group on Health Technology Assessment (the ‘HTACG’) hosted by the European Commission.