HAS annual report of activities

HAS has today (2nd July 2015) published its Annual Report for 2014.

Regarding medicinal products:

  • 630 opinions were published in 2014:
    • first registration: 190 opinions (30%)
    • extension of indication: 45 opinions (7%)
    • Renewal: 184 opinions (29%)
    • Other: 211 opinions (34%)
  • The median duration of evaluation was 107 days.
  • In first registration, one product recevied ASMR I Orphacol), 5 products received ASMR II (Bexsero, Kadcyla, Kineret, Sovaldi, Succicaptal) and 7 products received ASMR III (Carmyne, Hemangiol, Immovid, Revlimid, Sovaldi, Tivicay, Vimizin).

Regarding medicinal devices:

  • 195 opinions were published in 2014:
  • first registration: 78 opinions (40%)
  • modification of conditions for registration: 46 opinions (24%)
  • Renewal: 58 opinions (30%)
  • Other: 13 opinions (6%)
  • The mean duration of evaluation was 86 days.
  • In first registration, 5 medical devices recevied ASA III (Lifevest, I-limb ultra, E-vita Open plus, Thoraflex hybrid, Integra Dermal Regeneration template).

A summary of the report can be found here, or the full report can be read here (both available in French only).

 

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Published on 2. July 2015 in News France