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