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HAS Early Access Program: Positive Trends After Two Years

The Haute Autorité de Santé (HAS) has recently shared a two-year summary of its Early Access program. The highlights include:

  • Application Growth: witnessed a robust growth in applications, reaching a total of 250 in two years, with a consistent upward trajectory each semester
  • Support Meetings: participated in ~100 pre-depot support meetings in collaboration with the ANSM, resulting in the deposition of 90 dossiers
  • Positive Decision Rate: achieved 78% success rate in positive decisions
  • Timely Evaluation Process: adhered to a 78-day evaluation period, meeting the 90-day statutory deadline as part of the program’s dedication to prompt decision-making
  • Accelerated Reimbursement Access: minimized the waiting period for access to the reimbursement list to approximately 9 months before inclusion in the reimbursement list

Additionally, in a stride towards enhanced transparency, the HAS has initiated a dynamic dashboard on its website. This feature provides regular, insightful updates on drug evaluation timelines for both standard evaluations and those under the early access framework.

For more information on the Early Access in France.


Dynamic dashboard :

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