June 29, 2020
Outcomes of the AIFA's technical-scientific committee June 2020 meeting published
The technical-scientific committee (CTS) of the Italian Drugs Agency (AIFA) held their meetings on June 9-12, 2020. The CTS published six types of outcome documents:

  • Market Authorizations (national procedures)
    • CTS expressed opinions for approximately sixty (60) Marketing Authorization procedures, most of which were positive
    • CTS expressed positive opinion for parallel import of more than ten (10) products
  • Pre-Authorization
    • Drug list 648/96
      • CTS postponed decision-making for eight (8) medicines
      • CTS made negative decisions for ten (10) medicines
      • CTS made positive decisions for six (6) medicines
      • CTS is still discussing two (2) medicines
    • AIFA 5% list
      • All four (4) drugs are still being discussed
  • Post-marketing vigilance
  • HTA and pharmaco-economics
    • Regarding orphan drugs:
      • CTS is reviewing Waylivra, Onivyde, and Givlaari
      • Sent to CPR for pricing decision: Xermelo, Epidyolex
  • CTS grouping of drugs that obtained Market Authorization through the centralized procedure (via EMA). Sixteen (16) opinions were published
  • Monitoring registries opinions:
    • Registry schemes to be assessed / approved by the CTS:
      • Postponed: VITRAKVI
      • Approved: WAYLIVRA, REVLIMID, TALZENNA, LYNPARZA, MVASI, KADCYLA (after additional discussions)
The CTS meetings are held monthly. The CPR meetings are usually held 7-10 days after the CTS meetings.

See all the details in Italian here.

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