In short: Biotechnology legal work in Türkiye starts with product classification and connects TİTCK or biosafety approvals, clinical research, tissue and cell rules, IP, contracts, genetic data and commercialization.
Who we advise: Foreign biotech companies, life sciences businesses, manufacturers, diagnostic companies, research organisations, laboratories, investors and technology developers operating in or entering Türkiye.
Our Biotechnology Legal Services in Turkey
Our biotechnology lawyers assist international companies from the earliest R&D stage through Turkish market entry, regulatory approval, commercialization, licensing and dispute resolution.
Market Entry and Classification
Turkish company, subsidiary, joint venture, importer, distributor, R&D and technology-development-zone structures, with product-specific classification.
TİTCK Regulatory Advice
Biological medicines, biosimilars, ATMPs, clinical trials, medical devices, IVDs, manufacturing, imports, labelling and post-market obligations.
Clinical Trials and CROs
CTA, site, investigator, CRO, clinical supply, laboratory, data-management, pharmacovigilance, consent, insurance and safety documentation.
GMO and Biosafety
Law No. 5977 analysis for agricultural and industrial biotechnology, including approvals, import, feed, labelling, storage, traceability and administrative risk.
Biotech Patents and Licensing
Patent strategy, biological materials, employee inventions, freedom to operate, know-how, regulatory dossiers, technology licences and commercialization rights.
Genetic Data and KVKK
Genetic, health, clinical, genomic and biobank data mapping, privacy documentation, VERBIS, Data Controller Representative and international transfers.
Manufacturing and Distribution
CDMO, quality, technology transfer, supply, batch release, cold chain, pharmacovigilance, recalls, importer and distribution arrangements.
Investment and Disputes
Regulatory due diligence, biotech M&A, joint ventures, IP ownership, failed R&D, licence, manufacturing, supply, patent and regulatory disputes.
Biotechnology Market Entry in Turkey
A foreign biotechnology company can interact with Türkiye through cross-border product supply, a Turkish importer or distributor, a subsidiary, a research company, a joint venture, university collaboration, technology licensing, clinical trial sponsorship, contract research, local or contract manufacturing, acquisition or a technology development zone.
Before selecting a model, we assess the product classification, TİTCK authorization, GMO rules, manufacturing permissions, importer role, clinical research, biological-material entry, genetic or health data, IP ownership, R&D incentives and commercialization contracts. Incorporating a Turkish company does not itself authorize a regulated activity.
Biotechnology Regulatory Classification
The commercial label “biotech product” has little regulatory meaning on its own. The first question is what the product, technology or research activity actually is and what claims or intended use it has.
- Biological or biosimilar medicinal product;
- Advanced therapy medicinal product, gene therapy or cell therapy;
- Medical device, in vitro diagnostic or research-use-only product;
- Human tissue, cell product or biobank activity;
- Genetically modified organism, food, feed or agricultural biotechnology;
- Research material, reagent, biological sample or industrial biotechnology.
The same technology can enter a different regime depending on intended use. A diagnostic kit may be an IVD, while a genuinely research-use-only reagent may require a separate analysis; a gene therapy may fall within the ATMP framework, and an agricultural GMO may trigger Biosafety Law No. 5977.
Who Regulates Biotechnology in Turkey?
Biological Medicines and Biosimilars
Biological medicinal products generally enter Türkiye’s human medicinal product marketing authorization framework. The legal and regulatory work can include the applicant structure, dossier, manufacturing, GMP, active substance, quality, safety, efficacy, clinical data, pharmacovigilance, labelling, import and post-authorization changes.
Biosimilars are not treated as ordinary generics. The current TİTCK biosimilar guideline was revised on 21 April 2026 and addresses scientific and regulatory principles for analytical comparability, quality, non-clinical requirements, clinical requirements and overall biosimilarity evaluation.
Gene, Cell and Advanced Therapy Products
Gene therapy, somatic cell therapy, tissue-engineered products and combined advanced therapy products can fall within Türkiye’s Advanced Therapy Medicinal Products framework. The dedicated ATMP Marketing Authorisation Regulation has been in force since 27 May 2023 and addresses authorization, pharmacovigilance and post-market requirements for qualifying industrially prepared products.
We connect the scientific product description with authorization strategy, manufacturing, clinical evidence, biological materials, quality, data, IP, supply and commercialization responsibilities.
Clinical Trials, Research and CRO Agreements
Clinical research should be structured around sponsor obligations, TİTCK or Ministry requirements, ethics review, site and investigator arrangements, informed consent, insurance, safety reporting, biological samples, trial data and study termination.
Clinical documentation
Clinical Trial Agreements, site and investigator agreements, CRO, clinical supply, laboratory, central laboratory, data-management and pharmacovigilance agreements.
Research governance
University collaborations, biological material use, publication rights, confidentiality, data access, research results, inventions, patient information and termination.
Human Tissue, Cell Products and Biobanks
Human tissue and cell activities can involve processing, storage, traceability, transport, import, export, clinical use and regulated centres. The Regulation on Products Derived from Human Tissues and Cells and Related Centres, published on 4 September 2025 and effective from 1 January 2026, creates a detailed framework for qualifying centres and clinical-use biobanks.
We assist with scope analysis, preliminary permissions, licensing, centre requirements, tissue and cell processing agreements, storage, third-party services, data governance and regulatory inspections. Research-only activities require a separate analysis of their actual scope.
GMO and Biosafety Compliance
Biosafety Law No. 5977 applies to regulated activities involving genetically modified organisms and their products, including research, development, processing, placing on the market, monitoring, use, import, export, transportation, storage, packaging and labelling.
GMO products within the Biosafety Law framework cannot be placed on the market without applicable approval or used outside the approved purpose. Current Ministry guidance states that no GMO products have been approved for food use in Türkiye, while specified feed uses are subject to separate approvals and controls.
Biotechnology Patents, Licences and R&D Agreements
Biotechnology value often sits in patents, biological materials, cell lines, processes, know-how, regulatory dossiers, clinical data and research results. We advise on Turkish patent strategy, PCT and EPC coordination, biological-material deposits, employee inventions, ownership, freedom to operate, licensing and patent disputes.
- Material Transfer Agreements for cells, microorganisms, DNA, RNA, plasmids, proteins and samples;
- Sponsored, collaborative, joint-development, research-services and university–industry agreements;
- Technology and patent licences covering field of use, improvements, sublicensing and commercialization;
- Confidentiality, publication, biological-material handling, data access and research-result provisions.
Genetic Data, KVKK and Cross-Border Transfers
Biotechnology businesses may process genetic information, sequencing results, biological-sample identifiers, patient and health records, clinical-trial data and genomic datasets. Genetic and health data are special-category personal data under KVKK and require enhanced processing, security, documentation and transfer analysis.
For foreign controllers, the work can include KVKK applicability, Data Controller Representative appointment, VERBIS registration, processing inventories, privacy documents, data-subject requests and Authority communications. International transfers to parent companies, CROs, central laboratories, genomic analysis providers, cloud platforms and global clinical systems should be mapped under Article 9 of KVKK, including available Standard Contract or Binding Corporate Rules mechanisms.
Manufacturing, Distribution, Investment and Disputes
Commercial agreements must match regulatory quality responsibilities. We prepare and review CDMO, contract manufacturing, quality, technology transfer, manufacturing licence, clinical supply, raw-material supply, importer and distribution agreements covering specifications, GMP, batch release, deviations, CAPA, change control, cold chain, complaints, recalls, inspections, pharmacovigilance, exclusivity, sales targets and termination.
For investors and acquirers, due diligence covers classification, authorizations, GMO permissions, clinical programmes, ethics approvals, tissue or cell licences, patents, freedom to operate, MTAs, biological-material ownership, clinical data, manufacturing, quality systems, distribution, grants, incentives and litigation.
Biotechnology disputes may involve patent infringement or ownership, licences, royalties, research milestones, failed development, biological materials, confidentiality, manufacturing, quality, distribution, regulatory decisions and investment agreements. Depending on the matter, negotiation, mediation, Turkish litigation, IP proceedings, administrative review or ISTAC, ICC or another arbitration forum may be relevant.
Biotechnology Law in Turkey: Frequently Asked Questions
What law regulates biotechnology companies in Turkey?
There is no single Biotechnology Law. The applicable rules depend on the product and can include Biosafety Law No. 5977, medicinal product regulation, ATMP rules, clinical trial regulation, medical device and IVD rules, human tissue and cell regulation, Industrial Property Code No. 6769 and KVKK.
Who regulates biotechnology companies in Turkey?
Depending on the activity, relevant authorities can include TİTCK, the Ministry of Health, the Ministry of Agriculture and Forestry, TÜRKPATENT, the Personal Data Protection Authority and the Ministry of Industry and Technology.
Can a foreign biotech company establish a company in Turkey?
Yes. However, corporate establishment does not itself authorize a regulated biotechnology activity. Product classification and sector-specific licensing should be assessed separately.
How are biological medicines regulated in Turkey?
Biological medicines generally fall within Türkiye’s human medicinal product marketing authorization framework administered by TİTCK. The review can involve the applicant, dossier, manufacturing, GMP, quality, safety, efficacy, clinical data, pharmacovigilance, labeling and import.
How are biosimilar products regulated in Turkey?
TİTCK maintains a dedicated biosimilar guideline. The current guideline was revised on 21 April 2026 and establishes updated scientific and regulatory principles for biosimilar development and authorization, including analytical, quality, non-clinical and clinical comparability.
Is gene therapy regulated in Turkey?
Yes. Qualifying gene therapy products can fall within the Advanced Therapy Medicinal Products regime established by the Regulation in force since 27 May 2023.
Are cell therapy products regulated in Turkey?
Yes. Depending on the product and processing model, ATMP legislation and/or the human tissue and cell regulatory framework can apply.
Are biobanks regulated in Turkey?
Certain biobanks are. The human tissue and cell Regulation effective from 1 January 2026 establishes a licensing framework for qualifying biobanks connected with clinical use. Research-only activities require separate scope analysis.
Do clinical trials require approval in Turkey?
Regulated medicinal-product clinical trials require the applicable ethics review and TİTCK or Ministry authorization before commencement. Sponsor, site, investigator, CRO, insurance, consent, safety reporting and data arrangements should be documented.
Are genetic testing kits regulated as medical devices?
Where a product is intended for in vitro diagnostic use, the Turkish IVD Regulation may apply. Genuinely research-use-only products can fall outside the IVD framework depending on their intended purpose and claims.
Are GMOs legal in Turkey?
GMO activities are strictly regulated under Biosafety Law No. 5977. Products cannot be placed on the market without applicable approval, cannot be used outside the approved purpose and certain activities are prohibited.
Can biotechnology inventions be patented in Turkey?
Yes, where the invention meets patentability requirements and is not within the statutory exclusions under Industrial Property Code No. 6769. Biological material deposit and employee-invention issues may also need to be addressed.
Is genetic data protected under KVKK?
Yes. Genetic and health data are special-category personal data under KVKK and receive enhanced protection. Clinical, genomic, sequencing, biobank and biological-sample data should be mapped accordingly.
Does a foreign biotechnology company need a Data Controller Representative?
Potentially. A foreign company that acts as a non-Turkish data controller and falls within the VERBIS framework may need to appoint a Data Controller Representative in Türkiye.
Can genetic or clinical data be transferred abroad?
Potentially, subject to Article 9 of KVKK and the applicable international transfer mechanism, such as an adequacy mechanism, Standard Contract, Binding Corporate Rules or another legally available safeguard.
Can GMO food be imported into Turkey?
The current approval position described by the Ministry is that no GMO products have been approved for food use in Türkiye, so GMO food imports are not permitted under that framework. Feed uses are subject to separate approvals and controls.
What contracts do biotechnology companies need in Turkey?
Common documents include licence, Material Transfer, sponsored research, collaboration, joint development, clinical trial, CRO, laboratory, CDMO, manufacturing, quality, supply, distribution, confidentiality, DPA, technology transfer and joint venture agreements.
Can Turkish Trade Lawyers prepare biotech licensing and research agreements?
Yes. We advise on biotechnology licences, MTAs, R&D and university collaboration agreements, clinical trial documentation, CDMO and manufacturing agreements, distribution contracts, data agreements and related commercial documentation.
Biotechnology Legal Counsel for Foreign Companies
Biotechnology in Türkiye operates across multiple regulatory layers. The correct legal route connects market entry, classification, TİTCK or biosafety authority, R&D, clinical trials, authorization, tissue and cell rules, patents, licensing, manufacturing, imports, genetic data, commercialization and disputes.
