Türkiye İlaç ve Tıbbi Cihaz Kurumu

What Türkiye İlaç ve Tıbbi Cihaz Kurumu does

Türkiye İlaç ve Tıbbi Cihaz Kurumu (TİTCK) is the national regulatory agency of the Republic of Turkey responsible for the regulation, licensing, surveillance, and post-market oversight of pharmaceuticals, medical devices, cosmetics, biocidal products, herbal medicinal products, and homeopathic products. Established in 2011 and headquartered in Ankara (Çankaya) with 287 employees, TİTCK operates under the Turkish Ministry of Health as the sole competent authority in its regulatory domain, with no private-sector or competing public counterpart in Turkey.

TİTCK runs an integrated digital regulatory platform spanning the full product lifecycle. Operational systems include the Drug Tracking System (İTS) and Product Tracking System (ÜTS) for supply-chain visibility, the e-prescription platform (Reçetem), the clinical trials registry (KAP), the electronic applications portal (EBS), the pharmacist placement system (EYS), the pharmacovigilance center (TÜFAM), and the Turkish Pharmacopoeia (Türk Farmakopesi). The agency conducts batch-level drug recalls, executes Good Manufacturing Practice inspections, and issues or withdraws market authorizations across its regulated product categories, including active intervention on devices such as the Allurion Gastric Balloon.

As a government entity, TİTCK has no commercial revenue model; it is funded through the Ministry of Health budget and does not charge regulated entities for licensing in a way that constitutes commercial revenue. Its strategic posture is shaped by international regulatory cooperation with EMA and other national authorities, ongoing IT platform expansion, inspector workforce build-out, and a 2025 roadmap push into advanced therapy medicinal products (ATMPs). In July 2025, Hüseyin Çelik was appointed as the agency's new President.

Name

Türkiye İlaç ve Tıbbi Cihaz Kurumu

Legal name

Türkiye İlaç ve Tıbbi Cihaz Kurumu

Website

https://titck.gov.tr

Company type

Private

Operating status

Operating

Headcount range

251–500 employees

Short description

Türkiye İlaç ve Tıbbi Cihaz Kurumu (TİTCK) is Turkey's sole national regulatory authority for pharmaceuticals, medical devices, cosmetics, and related products, headquartered in Ankara with 287 employees and funded through the Ministry of Health.

Ownership category

akta.pro rank

Product category

Pharmaceutical and Medical Device Regulatory Services

NAICS

Regulation, Licensing, and Inspection of Miscellaneous Commercial Sectors (92615)

akta.pro primary industry

Drug Regulators (Human Pharmaceuticals) (HLAJADAA)

akta.pro secondary industries

Medical Device Regulators (HLAJADAC), Clinical Trials Authorization & Oversight (GCP) (HLAJADAF)

Keywords

• Pharmaceutical regulation
• Medical device regulation
• Drug safety oversight
• Pharmacovigilance services
• Regulatory compliance

Headquarters

HQ city

Ankara

HQ country

Türkiye

HQ region

Europe

Offices1 record

Markets served

GTM type

B2B

Offering type

Services

Cost components

Personnel, Operations, Technology or R&D, Infrastructure, Others

Distribution channels1 record

Marketing channels4 records

Core offering

TİTCK is the sole national regulatory authority of Turkey for pharmaceuticals, medical devices, cosmetics, biocidal products, traditional herbal medicinal products, and homeopathic products. It grants market authorization, conducts GMP/GDP inspections, monitors pharmacovigilance, manages supply chain tracking via İTS and ÜTS, and processes regulatory applications through electronic submission systems (EBS, KAP). Operations are funded through the government budget with fees charged for licensing, GMP certification, and clinical trial approvals.

Product overview

TİTCK operates as Turkey's regulatory and supervisory authority for pharmaceuticals, medical devices, cosmetics, and related health products. The agency's digital infrastructure consists of multiple interconnected web-based systems organized by function: regulatory submission platforms (Elektronik Başvuru Sistemi, Klinik Araştırmalar Portalı), drug safety monitoring systems (İlaç Takip Sistemi, TÜFAM, Reçetem Sistemi), medical device tracking (Ürün Takip Sistemi), professional placement services (Eczacı Yerleştirme Sistemi), and public health information portals (Akılcı İlaç Kullanımı). These systems are accessed through the E-İşlemler (E-Transactions) web platform and are complemented by the Türk Farmakopesi quality standards reference.

Differentiator

Problem solved

Functional benefit

Products and services

• İlaç Takip Sistemi (İTS) - Drug Tracking System National real-time tracking system for pharmaceutical products from manufacturer to patient, supporting recall management, anti-counterfeiting measures, and supply chain visibility for the Turkish pharmaceutical market.
• Ürün Takip Sistemi (ÜTS) - Product Tracking System Comprehensive tracking system for medical devices with barcode-based identification and movement restrictions, tracking products from production to patient use.
• Reçetem Sistemi - Electronic Prescription System Electronic prescription management system enabling healthcare providers to issue, track, and verify prescriptions for human medicines digitally.
• Elektronik Başvuru Sistemi (EBS) - Electronic Application System Online platform for pharmaceutical and medical device companies to submit regulatory applications, license requests, and external opinion requests electronically.
• Klinik Araştırmalar Portalı (KAP) - Clinical Research Portal Web portal for submission, tracking, and management of clinical trial applications, approvals, and related regulatory documentation.
• TÜFAM - Türkiye Farmakovijilans Merkezi (Pharmacovigilance Center) Turkey's national pharmacovigilance center responsible for monitoring and collecting adverse drug reaction reports to ensure drug safety across the Turkish market.
• Akılcı İlaç Kullanımı - Rational Drug Use Portal Public education platform providing information on appropriate medication use, dosage, and safety for healthcare professionals and the general public.
• Eczacı Yerleştirme Sistemi (EYS) - Pharmacist Placement System System managing pharmacist placement examinations and career placement processes for pharmaceutical workforce distribution in Turkey.
• Türk Farmakopesi - Turkish Pharmacopoeia Official quality standards and specifications reference for pharmaceutical substances and preparations used in the Turkish market.
• İlaç Yan Etki Bildirim Sistemi - Adverse Drug Reaction Reporting System Reporting system enabling healthcare professionals and patients to report side effects and adverse reactions of medications to TÜFAM.
• Geri Çekme ve Satış Blokajı RSS Yayını - Recall and Sales Blockage RSS Feed Automated RSS feed service providing real-time notifications on drug recalls and sales blockages issued by the agency.
• Ulusal Seri Serbest Bırakma Sistemi - National Batch Release System National system for quality control testing and regulatory release of pharmaceutical product batches before market authorization.

Quantifiable outcome

• Maintains comprehensive recall system with continuous publishing of drug withdrawal announcements since 2018
• +2 more outcomes

Segments5 records

Ideal customer profiles3 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature5 records

Partnerships

Four partnerships are on record, tiered core and major.

• International Medicines and Medical Devices Regulatory AuthoritiescoreStrategic or Co-development Partner · 1 March 2019TİTCK organizes international information meetings for medicines and medical devices regulatory authorities from other countries. The 3rd Information Meeting included modules on human medicines, medical devices, and pharmacoeconomics presented by TİTCK experts. Attendance was limited to two representatives per country, with accommodation covered by TİTCK. The program facilitates regulatory policy sharing and networking among participating national authorities.
• Sağlık Bakanlığı (Ministry of Health)coreStrategic or Co-development PartnerTİTCK operates under the Republic of Turkey Ministry of Health as its primary regulatory arm for pharmaceuticals and medical devices. The agency reports to the Ministry and implements national health policy related to drug and device regulation.
• European Medicines Agency (EMA)majorStrategic or Co-development PartnerTİTCK references EMA safety warnings and coordinates recall actions based on EMA official communications. The agency aligns its regulatory decisions with European pharmaceutical regulations and participates in international regulatory harmonization efforts.
• Sosyal Güvenlik Kurumu (SGK - Social Security Institution)majorOthersTİTCK coordinates with SGK on drug pricing, reimbursement policies, and the implementation of reference pricing systems. The agency publishes reference-based drug pricing lists that are used in conjunction with SGK reimbursement decisions.

Scale indicators4 records

Recent moves6 records

Expansion highlights5 records

Direct peers

• India's Central Drugs Standard Control Organisation (CDSCO): India's national regulator for drugs, cosmetics, and medical devices. Comparable in overseeing a large emerging-market pharmaceutical sector, including licensing, clinical trial oversight, and pharmacovigilance.
• Health Canada: Canada's federal health regulator covering drugs, medical devices, and consumer health products. Comparable mandate to TİTCK including market authorization, post-market surveillance, and recall authority.
• European Medicines Agency (EMA): The EU's central medicines regulator covering marketing authorization, pharmacovigilance, and clinical trial oversight across EU member states. TİTCK explicitly aligns with EMA standards and coordinates on safety actions, making it the closest functional analogue.
• Japan's Pharmaceuticals and Medical Devices Agency (PMDA): Japan's national regulator for pharmaceuticals, medical devices, and regenerative medicine. Comparable in integrating review, safety, and relief functions, and a useful analogue given its work on advanced therapy regulation that TİTCK is now building toward.
• Germany's Federal Institute for Drugs and Medical Devices (BfArM): German federal regulator responsible for medicinal product authorization, pharmacovigilance, and medical device risk assessment. Closely comparable mandate to TİTCK across the same product categories and oversight functions.
• UK Medicines and Healthcare products Regulatory Agency (MHRA): National UK regulator for medicines, medical devices, and blood components. Comparable in scope to TİTCK, including licensing, pharmacovigilance, and inspection duties, with similar digital infrastructure for applications and adverse-event reporting.
• Brazil's Agência Nacional de Vigilância Sanitária (ANVISA): Brazil's health regulatory agency for medicines, medical devices, cosmetics, and sanitizing products. Closely analogous to TİTCK in scope across pharmaceuticals and medical devices, and in operating as a national single-window regulator in an emerging market.

Regional players

• Saudi Food and Drug Authority (SFDA): Saudi Arabia's regulator for food, drugs, and medical devices. Comparable mandate to TİTCK and a relevant regional peer for Middle East / North Africa regulatory alignment and cooperation programs.

Broad incumbents

• U.S. Food and Drug Administration (FDA): The U.S. federal regulator for drugs, biologics, and medical devices. Directly comparable to TİTCK in mandate (market authorization, pharmacovigilance, GMP inspections, recall authority), but operating at much larger scale and with greater global influence.
• China National Medical Products Administration (NMPA): China's national regulator for drugs, medical devices, cosmetics, and food. Comparable in the breadth of product categories regulated and in operating under a state-driven model similar to TİTCK's.

Market position

Strengths4 records

Weaknesses4 records

Competitive moat4 records

Key risks6 records

Key highlights6 records

Customer concentration

• LinkedInlinkedin.com/company/t%C3%BCrkiye-i%CC%87la%C3%A7-ve-t%C4%B1bbi-cihaz-kurumu

Revenue estimate

Valuation estimate

Number of profiles

Profiles1 record

Funding overview

Funding rounds

Investors

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M&A

Investments

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