Two core documents govern the advanced therapy medicinal products (ATMP) landscape in Türkiye, forming a complementary framework: the Regulation on the Licensing of Advanced Therapy Medicinal Products (Official Gazette 27 May 2023, No. 32203) and the Guideline on Good Clinical Practice Principles for Advanced Therapy Medicinal Products (13 November 2015). The Regulation covers licensing and pharmacovigilance; the Guideline governs clinical research practice. This post summarises the scope of both documents, the ATMP definition, the hospital exemption mechanism, and the practical implications for sponsors.
What is an ATMP? The three categories under Turkish legislation
According to the Regulation's definition, an advanced therapy medicinal product is any human medicinal product falling under one of the following three categories:
- Gene therapy medicinal product — products defined in Annex-5 that contain genetic material or use genetic modification in their manufacture.
- Somatic cell therapy medicinal product — products containing living human cells or tissues that exert pharmacological, immunological or metabolic action.
- Tissue-engineered product — products containing living or non-living human or animal cells/tissues intended for regeneration, repair or replacement.
The Regulation also defines the combined advanced therapy medicinal product: ATMPs containing a medical device component are always evaluated under this Regulation, regardless of the device's role, because the pharmacological, immunological or metabolic action of the cells or tissues is accepted as the principal mechanism of action. The Regulation further introduces the bioengineering product concept: cell/tissue products that have undergone significant manipulation and are not intended for the same essential function in the recipient as in the donor.
The Licensing Regulation: what does it govern?
The 46-article Regulation (27 May 2023) governs the licensing of ATMPs that meet the required efficacy, safety and quality standards, and their post-authorisation pharmacovigilance. Key topics:
- Out of scope: Products prepared by fundamentally non-routine methods falling under hospital exemption (see dedicated section below); vaccines; non-viable cell/tissue products whose principal action is not pharmacological, metabolic or immunological.
- Licensing application: Applications are made to the Agency with the information and documents specified in Annex-5. GMP compliance is assessed before or during the process.
- Conditional licensing: The Regulation permits conditional licensing where efficacy and safety data are still incomplete — convertible to a full licence when complementary data become available.
- Pharmacovigilance: Post-authorisation safety surveillance, risk management plans and periodic safety reports ensure continuous monitoring.
- Corrective instructions: When non-compliance is identified, the manufacturer is asked to correct; if obligations are not fulfilled, the Agency can initiate an inspection and the licence can be revoked.
- Licence transfer: Existing licences can be transferred, subject to an application with the required documents.
Hospital exemption: the special channel for ATMPs
The Regulation defines the hospital exemption mechanism — Türkiye's counterpart to the EU's "hospital exemption". The essence of the definition: clinical research authorisations granted by the Ministry for ATMPs that are prepared by fundamentally non-routine methods, prescribed specifically for a single patient, under the responsibility of healthcare professionals in a hospital setting.
What this means: bespoke ATMPs prepared by non-routine methods for individual patients can be used in a hospital environment under experienced physician oversight, without going through the full licensing process. This is a critical access channel, particularly for personalised cell therapies and tissue-engineered products in rare diseases.
The GCP Guideline: clinical research practice with ATMPs
Published in 2015, the Good Clinical Practice Guideline provides a 19-section practical framework for the use of ATMPs in clinical research:
- Cell/tissue procurement: Separate requirements for tissue centres, blood establishments, animal facilities and manufacturers; donor selection, donation and procurement processes.
- Fundamental principles: Quality, safety and traceability principles in ATMP research.
- Traceability: Recording the entire chain from donor to volunteer.
- Safety reporting and long-term follow-up: The requirement for long-term safety surveillance due to the persistent effects of ATMPs.
- TİTCK authorisation process: Agency submission, assessment and authorisation stages.
- Ethics committee approval: Principles for ethics committee evaluation of ATMP research.
- Informed consent form requirements: Special requirements for the informed consent form (ICF) in ATMP research.
- Sponsor responsibilities: Additional obligations of the sponsor in ATMP research.
- Protocol and investigator's brochure: Content requirements specific to ATMPs.
The ICH E6(R3) connection
The ATMP guideline was published in 2015; ICH E6(R3) and its decentralised-elements annex (Annex 2) reached final in June 2026. Read together, they paint a consistent picture: the decentralised elements defined in E6(R3) Annex 2 — home visits, mobile medical units, DHT-based data collection — align naturally with the traceability and long-term follow-up requirements of ATMPs. Given the personalised manufacturing and complex logistics of ATMPs, home-based follow-up and remote monitoring models are particularly valuable for these products. See our CIOMS/ICH Glossary V10 post for a detailed treatment of E6(R3) Annex 2 terminology.
Five practical takeaways for sponsors
1. Classify your product as an ATMP early. Which of the three categories — gene therapy, somatic cell therapy or tissue engineering — your product falls under directly shapes the format, scope and assessment process of your application dossier.
2. Clarify the boundary between hospital exemption and full licensing. For bespoke products prepared by non-routine methods, hospital exemption offers a fast channel; for industrially manufactured products, the full licensing process is required.
3. Build the traceability chain from the outset. Recording every step from donor selection to administration is a core expectation of both the GCP Guideline and E6(R3).
4. Plan long-term follow-up early. The persistent effects of ATMPs may require safety surveillance for years after trial completion — this must enter the study budget and operational plan from the start.
5. Assess Türkiye's ATMP infrastructure. Cell processing centres, tissue banks and experienced sites are limited in number; the right site selection directly impacts start-up timelines. Our cell and gene therapy page maps Türkiye's ATMP research infrastructure.
Frequently asked questions
Which products fall under ATMP? Gene therapy medicinal products, somatic cell therapy products and tissue-engineered products — plus combined ATMPs containing a medical device component.
Who is hospital exemption for? ATMPs prepared by non-routine methods, bespoke for a single patient, administered in a hospital under physician oversight. It enables obtaining clinical research authorisation without going through the full licensing process.
Are there additional requirements for clinical research with ATMPs? Yes: the donor-cell/tissue-volunteer traceability chain, long-term safety follow-up, and ATMP-specific protocol and investigator's brochure contents are all detailed in the GCP Guideline.
Where can I access these documents? The full texts and English translations of both documents are published in our legislation library; they are also downloadable as PDFs.
How should I evaluate Türkiye for my ATMP research? Türkiye is well positioned in terms of rare disease population, ethics committee experience, cell processing infrastructure and rapid start-up capability. Start from our cell and gene therapy page.
Source: Regulation on the Licensing of Advanced Therapy Medicinal Products (OG 27/5/2023-32203) and Guideline on Good Clinical Practice Principles for Advanced Therapy Medicinal Products (13 November 2015), TİTCK. The full texts of both documents are available in our legislation library.