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LICENSING AND COMPLIANCE WITH INTERNATIONAL STANDARDS

With the vision of a healthier future, within the scope of the AIFD strategic priorities set for the 2021-2023 period, the Health Science Policy Strategic Steering Committee (HSP-SMC), its Core Committees and Working Groups continued their activities in the following two strategic priority areas in 2022 with monthly meetings and when necessary with additional meetings:

1- Timely Access to Innovative Treatments
  • Licensing approvals
    • Acceleration of approval processes
    • Improving the process
    • Improving quality
    • Separating the scientific review process from economic evaluation

2- Compliance with International Standards
  • Turkey's compliance with global regulatory standards in the field of innovative products and biosimilars
  • Alignment with European and Customs Union modernization



The list of Core Committees and Working Groups within HSP-SMC are listed below:

CORE COMMITTEES
  • License Core Committee
  • Biotherapeutics Core Committee
  • Rare Diseases Core Committee
  • Advanced Therapy Medical Products Core Committee
WORKING GROUPS
  • Reliance Working Group
  • Good Review Practices (GRevP) Working Group
  • Analysis Processes Working Group
  • Pharmacovigilance Working Group
  • Quality and Supply Chain Working Group
PROJECT GROUP
  • AIFD & IQVIA Rare Diseases in Türkiye Report Project Group