3 July 2026 – ANKARA
Reducing bureaucracy in the healthcare sector, The radical legislative change prepared to adapt to global medical technologies and introduce digital control mechanisms has come into force.. 3 July 2026 dated and 33299 published in the Official Gazette No. “Regulation on Amending the Regulation on the Duties and Working Procedures and Principles of the Service Units of the Affiliated Organizations of the Ministry of Health”, Turkish Medicines and Medical Devices Agency (TİTCK) vice presidents within, Redesigned task areas and audit processes according to the needs of the age.
With this reform carried out within the framework of compliance with the Presidential Decrees,, From medicine to medical device, A new era begins in critical areas, from hemp-based products to artificial intelligence-supported inspections.
1. Legal Infrastructure Adapted to the Presidential Government System
With the first two articles of the regulation, The legal basis of the institution has been updated. Former repealed Decree Laws (663 Decree No.) By removing the references; 1 numbered and 4 Full compliance with the relevant articles of Presidential Decree No.. With this move, The organizational structure of ministry subsidiaries has been fully optimized from an administrative perspective.
2. Vice Presidencies Restructured: Here is the New Showcase
With the regulation, both the names and job descriptions of the strategic departments and vice presidents within TITCK were changed.:
Vice Presidency of Pharmaceuticals and Biological Products
Old Name: Vice President of Medicine and Pharmacy
this unit, will go beyond traditional drug management and manage the medical technologies of the future.
- Advanced Treatment Products: somatic cell therapy, gene therapy, allowing biotechnological and innovative products such as tissue engineering and combined advanced therapy medicinal products, licensing and preliminary evaluation processes have become the main task of this unit.
- Hemp and Alternative Supplements: Health and supplement products derived from hemp, homeopathic medicinal products, effectiveness of aromatherapeutic products and traditional herbal medicinal products, Licensing will be carried out by this unit in line with quality and safety data.. At the same time, clinical studies of these products will be closely monitored..
Vice President of Pharmacy and Market Management
Old Name: Vice Presidency of Economic Evaluations and Laboratory Services
industry's commercial, A huge structure was established that gathers logistics and field organization under one roof..
- Pharmacy and Warehouse Management: All regulatory works regarding pharmacies, The resolution of disputes that may arise and the coordination of licensing and inspection of pharmaceutical warehouses by Provincial Health Directorates were given to this unit..
- Imports, Export and Controlled Substances: Import and export monitoring activities of human medicinal products and pharmaceutical raw materials will be carried out.. Tracking of controlled substances subject to national and international red/green prescription will also be in this unit..
- EU and International Integration: Alignment with the European Union acquis, international relations and external communication coordination will now be managed by this vice presidency.
Vice President of Analysis and Support Services
Old Name: Support Services and Information Management Vice Presidency
It has become both the kitchen and technology base of the institution..
- Laboratory and Pharmacopoeia: Analysis of products, Quality control tests of medical devices and Turkish Pharmacopoeia (national medicine guide) Preparation was transferred to this unit.
- Digital Transformation Base: Data analysis of the institution, reporting, Statistical studies and R&D activities for advanced information technologies will be carried out here..
Vice Presidency of Medical Devices and Cosmetic Products
Risk classification of medical devices, technical service activities, test, control and calibration rules were determined from scratch. Authorization of approved bodies, Registration of cosmetics and biocidal products that come into direct contact with the human body and advertising for these sectors, Promotion and market research will be managed from a single center.
3. Inspections “Artificial Intelligence and Digital Data” period
One of the most striking articles of the regulation, Audit models have been modernized.
- Innovative Digital Methods: TİTCK, advanced technology and innovative digital methods to market controls (data analytics, artificial intelligence based algorithms) will integrate.
- Risk Based Audit: Market surveillance and control of products is uninterrupted (7/24) while being made, through risk analysis and risk assessment systems “preventive inspection” will be moved to the model.
4. Uncompromising Fight Against Counterfeit and Illegal Medicine
With the new regulation, it has become one of the most threatening elements to public health. counterfeit and smuggled drugs/medical products transactions were defined with a direct and more dynamic authority. This process will be supported by digital traceability infrastructure., It aims to prevent counterfeit products from infiltrating the system.
5. Health Technologies Assessment (STD) Mechanism Expanded
Health Technologies Assessment, which analyzes the clinical and economic burden/benefit of drugs and medical devices to the state and the patient (STD) mechanism, became one of the core duties of both Pharmaceuticals and Medical Devices vice presidents. In this way, it is aimed to provide a rational contribution to the reimbursement and licensing processes of innovative treatments..
Conclusion and Sectoral Reflections
It will be carried out by the Minister of Health and 3 July 2026 This regulation, which officially came into force as of; Turkey's biotechnology, demonstrates its determination to achieve global standards in advanced treatment methods and digital health management. In particular, herbal/health declared products such as hemp will have clear regulation and pharmaceutical processes will be managed more strongly under a single roof., It is described by industry stakeholders as a historic step in terms of market growth and security..
