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 Medical Technology and Interventional Procedure Committee (CNEDiMTS), Transparency Committee (CT) and/or the Commission for Economic and Public Health Evaluation (CEESP). 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 pharmaceuticals:
  • 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 and the Innovative medicine assessment action plan
• 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)

Please note that early dialogue requests and documents must be submitted using the  SESAME platform.

For additional information on early dialogues at the European level, with HAS and other HTA bodies and possibly the EMA

Please refer to the EUnetHTA  guidance and/or contact the EUnetHTA ED secretariat (EUnetHTA-HAS@has-sante.fr).