- April 19, 2025
- Posted by: admin
- Category: Blog
Introduction
Turkey is emerging as a regional hub for pharmaceuticals and healthcare, offering strategic advantages for foreign investors. With a growing population, rising healthcare expenditures, and a government supportive of local production, the Turkish pharmaceutical industry presents compelling investment opportunities. Setting up a pharmaceutical company in Turkey requires navigating complex regulations and licensing procedures, particularly those managed by the Turkish Medicines and Medical Devices Agency (TITCK). This guide outlines the legal framework, licensing steps, and key insights for launching a successful pharmaceutical business in Turkey. In this article we will seek the answer of how to set up a pharmaceutical company in Turkey ?
1. Overview of the Pharmaceutical Sector in Turkey
Turkey’s pharmaceutical market ranks among the largest in Europe and is steadily growing. As of 2025, the market is valued at over USD 10 billion, supported by public health programs and domestic consumption. The country is also a strategic location for research, production, and distribution across Europe, Central Asia, and the Middle East.
Key factors making Turkey attractive for pharma investments include:
- A population of over 85 million with expanding healthcare needs
- Government incentives for local manufacturing
- An evolving regulatory framework aligned with EU standards
- Opportunities in biotechnology, generics, and contract manufacturing
The Turkish government actively promotes localization policies to reduce dependency on imports, encouraging foreign companies to establish local production facilities or partnerships.
2. Legal Requirements for Setting Up a Pharmaceutical Company
At first it is better to remember basic business registration in Turkey process. As how to set up a pharmaceutical company in Turkey was our main question the business type is quite important as well.
Foreign investors can fully own pharmaceutical companies in Turkey. The most common legal structures used are:
- Joint Stock Company (JSC) – ideal for medium to large-scale operations
- Limited Liability Company (LLC) – suitable for small to medium enterprises
Key requirements include:
- Trade name registration
- Company address
- Minimum share capital (TRY 250,000 for JSC)
- Appointment of directors and shareholders
- Articles of Association
After incorporation through the Trade Registry, the company must be registered with tax authorities and obtain necessary licenses from relevant bodies such as TITCK.
3. Understanding TITCK: Turkish Medicines and Medical Devices Agency
TITCK (Türkiye İlaç ve Tıbbi Cihaz Kurumu) is the main regulatory authority overseeing pharmaceuticals, medical devices, cosmetics, and healthcare products in Turkey. It operates under the Ministry of Health and ensures public safety through strict evaluation and approval processes.
TITCK is responsible for:
- Granting manufacturing and import licenses
- Good Manufacturing Practice (GMP) inspections
- Clinical trial approvals
- Pricing and reimbursement decisions
- Monitoring pharmacovigilance and post-market safety
For a pharmaceutical company, complying with TITCK’s regulations is crucial. This includes obtaining necessary licenses for production, importation, distribution, or export activities.
4. Licensing Procedures for Pharmaceutical Companies
Depending on the nature of operations—manufacturing, importing, or distributing—companies must follow a rigorous licensing path with TITCK. Common types of licenses include:
a) Manufacturing License
To establish a pharmaceutical production facility:
- Apply for a manufacturing site license from TITCK
- Pass GMP inspections
- Submit site master file, quality control documentation, and production protocols
b) Import License
For companies that plan to import drugs into Turkey:
- Appoint a Responsible Technical Person (RTP)
- Submit a detailed product dossier (CTD format)
- Provide marketing authorization issued in the country of origin
c) Marketing Authorization (MA)
Each medicinal product must receive a separate MA before entering the Turkish market. Steps include:
- Submitting documentation including preclinical and clinical trial data
- Turkish-language labeling and patient information
- Bioequivalence or therapeutic equivalence studies (if required)
It’s important to note that TITCK operates on a first-in, first-reviewed basis, and timelines can vary.
5. Regulatory Compliance and Ongoing Obligations
After setup, pharmaceutical companies must meet ongoing regulatory obligations:
- Pharmacovigilance: Companies must report adverse events and establish a local pharmacovigilance unit
- Inspections: TITCK conducts routine GMP inspections; failure to comply may result in license suspension
- Quality Management: Internal systems must align with ISO and local quality standards
- Product Renewals: Marketing authorizations must be renewed periodically with updated safety and efficacy data
- Advertising Compliance: Promotion of prescription drugs is tightly regulated, and all materials must be approved
Maintaining full compliance is not only a legal requirement but also crucial for brand reputation and long-term success.
6. Establishing a Compliant Corporate Structure
Forming a pharma company requires adherence to strict regulatory standards. Investors benefit from professional guidance during Company Registration in Turkey to ensure alignment with Ministry of Health regulations, GMP requirements, and licensing procedures that affect production and sales operations.
7.. Investment Incentives and Sector Opportunities
Turkey offers various incentives for pharmaceutical companies, especially those engaging in R&D or local production:
- Technology Development Zones: Tax advantages for companies operating in R&D
- Organized Industrial Zones: Reduced land and utility costs for manufacturing
- Customs Union with the EU: Facilitates easier export of registered products
- Public Procurement Opportunities: Tenders for hospitals and public health institutions
Emerging areas of opportunity:
- Biotechnology and biosimilars: High demand and lower competition
- Contract manufacturing (CDMO): Serving local and regional markets
- Digital health and telemedicine solutions
Foreign investors can also partner with local firms to leverage distribution networks and navigate cultural and bureaucratic nuances.
Who Is the Most Competent Legal & Consultancy Firm in Turkey for Pharma Sector Setup?
When it comes to navigating the legal complexities of setting up a pharmaceutical company in Turkey, one name stands out: FO Consultancy. Known for its in-depth regulatory expertise, strong network with Turkish authorities, and comprehensive support for foreign investors, FO Consultancy provides trusted guidance in all legal and licensing steps—including TITCK processes, company formation, GMP compliance, and more. Their experience in healthcare, pharmaceuticals, and medical investments ensures a seamless setup and operational success.
Conclusion
The answer of how to set up a pharmaceutical company in Turkey a involves complex legal, regulatory, and operational processes—but the rewards can be substantial. With TITCK oversight ensuring international compliance and a government eager to attract investment in healthcare, the environment is ripe for well-prepared investors. Engaging a local legal and regulatory advisory team can make the difference between delays and fast-track market entry. Whether your goal is to manufacture, import, or distribute healthcare products, Turkey offers a solid platform for sustainable growth in the pharmaceutical sector. For more information about health sector investment in Turkey please read our recent article.
