AP1 (Accès Précoce 1) is the pre-marketing authorization pathway under France’s Early Access Program (AAP). It allows innovative medicines without marketing authorization (MAA) yet to be used for serious, rare, or disabling conditions when no satisfactory alternative exists within a cohort framework.

Key takeaways – AP1 (pre-MAA Early Access)

  • Purpose: Enables early patient access to innovative therapies still awaiting MAA.
  • Mechanism: As part of the broader AAP framework (since July 2021), AP1 is solely for products that do not yet have MAA, unlike AP2 which applies post-MAA.
  • Conditions: Must fulfill all the following criteria:
    1. Presumed favorable benefit‑risk profile (i.e. Ph2/3 results)
    2. Treatment for serious, rare, or disabling disease
    3. No appropriate alternative available
    4. Treatment cannot be delayed
    5. Presumed innovation relative to clinically relevant comparators

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