TİTCK Institutional Presentations

This TİTCK document (İDD-LST-05, first published 08.10.2026) provides the current list of contracted pharmacovigilance service organizations licensed by the TİTCK Inspection Services Vice Presidency. The list includes six organizations: DeltaPV Pharmaceutical Consultancy (certificate valid until 07.09.2029), Pleksus Pharmacovigilance Services and Clinical Research (31.07.2027), Pharmasoft Pharmaceutical Informatics Consultancy (25.09.2028), Mediskop Medical Consultancy and Pharmacovigilance (23.12.2028), IQVIA Medical Statistics (17.04.2027), and PVigi Medical Consultancy (02.12.2028). Contact details, addresses, and certificate validity dates are listed for all organizations; all are based in Istanbul. For sponsors and CROs, this list can be used to verify that service providers to whom pharmacovigilance obligations are outsourced hold a valid TİTCK license and to confirm certificate validity periods. Checking certificate validity before contracting is important for regulatory compliance.

This TİTCK presentation provides a current list of bioavailability/bioequivalence (BA/BE) centers that have been granted activity permit certificates by the Agency, ordered by permit number. The list covers 13 centers with permit numbers issued in 2023, 2025, and 2026; the scope of each permit is classified as "Clinical", "Clinical Bioanalytical", or "Bioanalytical".

The 2023 permits cover Yeditepe R&D and Analysis Center (YÜ-AGAM), NOVAGENIX, Istanbul University İLAM, Erciyes University Hakan Çetinsaya Good Clinical Practice Center, Selçuk University İKUM, FARMAGEN, Ankara Bilkent City Hospital Clinical Research Center, and Istanbul University Istanbul Faculty of Medicine Phase 1 and Clinical Research Center. The 2025 permits include Istanbul Health and Technology University, Kobay Laboratory Animals Beytepe Branch, and Afyonkarahisar Health Sciences University (PharmAFSU), while the 2026 permits cover Boğaziçi University Targeted Therapy Technologies Center and NANOLAB Edirne GLP Branch.

For sponsors and CROs, this list offers an up-to-date view of authorized centers capable of conducting bioequivalence and phase 1 clinical trials; when selecting a center, the permit scope (clinical, clinical bioanalytical, or bioanalytical) must be verified against the trial design. The centers are concentrated in Istanbul, Ankara, Kayseri, Konya, Gaziantep, Afyonkarahisar, and Edirne.

This TİTCK presentation provides the current list of Phase 1 clinical research centers that have been issued an operating permit (faaliyet izin belgesi) by the Authority, including permit number, version, center name, and address. The list is ordered by permit number and covers 24 centers permitted between 2023 and 2026. Permit numbers range from F1M/2023/01 to F1M/2026/06; almost all centers hold version 1 permits, with only the University of Health Sciences Ankara Abdurrahman Yurtaslan Oncology Education and Research Hospital Phase 1 Center (F1M/2024/01) holding a version 2 permit.

Geographically, the centers are concentrated in Ankara (7 centers), Istanbul (7 centers), and Izmir (3 centers) and the Aegean region, with single centers in Adana, Kayseri, Konya, Gaziantep, Antalya, and Samsun. The list includes university hospitals (e.g., Hacettepe, Ege, Dokuz Eylül, Gazi, Erciyes, Selçuk, Biruni, Izmir University of Economics, Demiroğlu Bilim, Istanbul University), city hospitals (Ankara Bilkent, Adana, Gaziantep), private hospitals (Medicalpoint, Memorial Antalya, Liv Hospital, Liv Topkapı, VM Medicalpark Samsun, Florence Nightingale), and an R&D center (Yeditepe R&D and Analysis Center). Oncology- and hematology-focused Phase 1 units (Hacettepe Medical Oncology, Ege Pediatric Hematology, Gazi Adult Hematology, SBÜ Ankara Oncology) also feature prominently.

For sponsors and CROs, this list serves as an important reference showing early-phase (Phase 1) clinical research capacity and site options in Türkiye, providing an up-to-date official resource for research center selection, budget planning, and partnership decisions.

This TİTCK presentation lists the foreign manufacturing facilities that underwent GMP inspections by the Authority (TİTCK — Türkiye İlaç ve Tıbbi Cihaz Kurumu) in 2024. The list includes facility names, full site addresses, and inspection dates. Inspections were carried out between early January and late December 2024, mostly over 4-5 day periods. A key footnote states that the GMP compliance status of a facility must be verified with the manufacturer.

The facilities span numerous countries including the USA, Germany, Switzerland, Italy, Spain, France, India, China, Singapore, Ireland, the Netherlands, Belgium, the UK, Denmark, Japan, South Korea, Brazil, Poland, Austria, Norway, Sweden, the Czech Republic, Hungary, Uruguay, and Puerto Rico. The list covers global pharmaceutical and biotechnology manufacturers — including Abbott, AbbVie, Amgen, AstraZeneca, BioNTech, Boehringer Ingelheim, CSL Behring, Eli Lilly, Janssen, Lonza, Merck/MSD, Moderna, Novartis, Novo Nordisk, Pfizer, Regeneron, Sanofi, Sandoz, Sinovac and Takeda — as well as contract manufacturing organizations (Catalent, Patheon, Recipharm, Vetter, Rentschler, Piramal, Lonza, etc.).

For sponsors and CROs, this list serves as a risk-based reference for supplier selection and supplier audit planning; before working with a facility supplying products or IMPs to Türkiye, it is advisable to check whether the facility was covered in the 2024 inspections and, per the footnote, to verify its GMP compliance status with the manufacturer.

This presentation is revision 00 of document İDD-LST-04 issued under TİTCK's drug inspection department, listing the foreign manufacturing facilities inspected by the Authority during calendar year 2025. The document, first published on 08.10.2026 and spanning 10 pages, presents in tabular form the facility name, address, and inspection date for each site. Inspections are spread across a calendar running from January 2025 (e.g., GlaxoSmithKline Biologicals in Singapore, 13-17 January 2025) to December 2025 (e.g., PCI Pharma Services Dublin in Ireland, 8-12 December 2025), with each inspection typically lasting five business days. The listed facilities are distributed across numerous countries including the USA, Germany, Ireland, Italy, France, Switzerland, India, China, the Republic of Korea, and Japan; several manufacturers such as Dr. Reddy's, Intas, Takeda, Novartis, Ferring, F. Hoffmann-La Roche, Novo Nordisk, and Pfizer had multiple sites inspected. A critical note in the document states that inclusion on the list does not constitute a GMP compliance guarantee; the facility's GMP compliance status must be queried from the manufacturer. For sponsors and CROs, this list serves as a primary reference for verifying the Authority's inspection history of foreign manufacturing sites during licensing and supplier selection processes; however, since the list conveys no status, current GMP standing must be confirmed with the manufacturer.

This presentation lists the organizations authorized under the Regulation on Testing, Control and Calibration of Medical Devices and their authorized scopes. The table includes sequence number, authorization date, organization name, address, authorization groups, authorized medical devices, and status (Active/Suspended). Twenty-two organizations are listed, including private calibration companies (e.g., Epsilon Landauer Dosimetry Technologies, Radkal Engineering, Unitest Testing and Calibration, Medibim, Biotest, Kalden, DK Hardware, Digital Technology Service, Etkin Calibration, BC Biomedical, Hünerli Medical, HTC Medical, Akme Medical, Aymet Biomedical, Ulusal Kalibrasyon, Turkmet, Meditest) as well as laboratories affiliated with universities and healthcare institutions (Istanbul University – Cerrahpasa Biomedical Coordination Calibration Laboratory, Gulhane Training and Research Hospital, Gazi University Biomedical Calibration and Research Center, Acibadem Polyclinics, University of Health Sciences Technology Development Zone Health Technopolis). Authorization dates range from 24.07.2020 to 22.09.2026, and all records are marked 'Active', although some organizations' authorizations for specific device branches are 'Suspended'. Authorization groups cover Flow, Weight, Length, Volume, Temperature, Pressure, Revolution; Electrosurgery Systems; Electrotherapy Systems; Physiological Signal Monitoring Systems; Respiratory Systems; Sterilization and Incubation Systems; Ultrasound-Doppler Imaging Systems; and Audiometric Systems. The presentation also notes that the obligation to have the listed devices tested, controlled and calibrated by authorized organizations has been temporarily lifted by the Authority under the third paragraph of Article 11 of the Regulation. Per the announcement of 03.09.2024, in addition to the obligation already initiated in Ankara, Istanbul, Izmir and Tekirdag, from 1/1/2025 it became mandatory to obtain testing, control and calibration services from authorized organizations for the Ultrasound-Doppler Imaging Systems group (fetal hand doppler), Physiological Signal Monitoring Systems group (EEG, EKG, Holter, Pulse Meter/SPO2/SPCO, medical monitor), the Flow-Weight-Length-Volume-Temperature-Pressure-Revolution group (operating table, aspirator, infusion pump, bed, incubator, perfusion pump, sphygmomanometer), and the Respiratory Systems group (anesthesia, bipap, cpap, spirometer, ventilator); following requests from healthcare service providers, this obligation was postponed to 1/7/2025. For sponsors and CROs, this list is the key reference for identifying authorized organizations and valid scopes for medical device calibration services, with attention to suspended branch types.

This TİTCK presentation lists the quality conformity assessment organizations authorized under the Regulation on Quality Conformity and Quality Control Tests for Diagnostic Radiology, Nuclear Medicine and Radiotherapy Group Medical Devices, along with their scopes of authorization. Four organizations are included: Kaltest QA Kalite Kontrol Test Muayene Çevre Ölçüm ve Eğitim Hizmetleri A.Ş. (authorized 06.06.2024, Kadıköy/İstanbul), Epsilon Landauer Dozimetri Teknolojileri Sanayi ve Ticaret A.Ş. (authorized 11.12.2024, Ataşehir/İstanbul), Prokal Kalite Uygunluk Belgelendirme Limited Şirketi (authorized 12.12.2024, Ümraniye/İstanbul), and Gelişim Kalite Kontrol Sistemleri Anonim Şirketi (authorized 28.07.2026, Şişli/İstanbul). All organizations are currently active. Their scopes vary by device group; within the radiotherapy group, scopes cover linear accelerators, imaging components of treatment systems, remotely controlled afterloading brachytherapy, treatment simulators, CT treatment simulators, helical tomotherapy, Co-60 source stereotactic radiotherapy devices, robotic linear accelerators, and intraoperative electron radiotherapy devices. Some organizations are also authorized for nuclear medicine group and diagnostic radiology group medical devices. The presentation further notes that, pursuant to paragraph twelve of Article 5 of the Regulation, the Authority has temporarily suspended the obligation to have quality conformity tests of these device groups performed by authorized organizations. For facility operators and sponsors, this list serves as the current reference for which tests may be performed by which authorized organizations, while the temporary suspension means the current obligation status should be tracked through TİTCK announcements.

This presentation covers the Sample Acceptance Criteria Procedure (PR10/KYB, code PR10/KYB; first issued 05.04.2021/05, revised 12.07.2023/04, 20 pages) of the TİTCK Analysis and Control Laboratories Department, together with its annexed Minimum Required Sample Quantity Tables for analyses (Tables 1a–10). The procedure defines the acceptance criteria and transport conditions for samples submitted to the Department for analysis and control, and sets out the respective responsibilities of the customer, sample acceptance personnel and laboratory personnel. Acceptance is documented via form F111/KYB; non-conforming samples are returned using the same form. For drug samples submitted for licensing, import authorisation, market surveillance and procurement purposes, at least 6 months of remaining shelf life is required, along with same-batch origin and intact packaging integrity. Complaint samples may be accepted regardless of table quantities; where storage conditions or packaging integrity are inadequate, acceptance or rejection is decided with the responsible unit head's approval. Product-group-specific provisions apply: for vaccines and immun sera produced in Türkiye, samples are not accepted unless the batch release application under the National Batch Release Regulation is completed; blood products for virological testing must have at least 3 months remaining shelf life. For medical nutrition products, minimum remaining shelf life depends on total shelf life (at least 6 months for >12 months shelf life; 4 months for 6–12 months; 2 months for 4–6 months). For medical devices and biocidal products, 'used samples' submitted via complaint or market surveillance do not qualify as samples and cannot be analysed. Cold-chain shipments must contain two dataloggers per parcel, with printouts recorded together with sample acceptance personnel. Exceptional acceptance of minimum quantity and shelf-life requirements is possible for crisis/emergency situations and market surveillance samples. For sponsors and CROs, this procedure serves as a practical reference for verifying licensing application readiness — including the Licensing Department's initiation letter, certificates of analysis, and reference standards (at least 6 months shelf life and sufficient for 4 analyses) plus active substance/impurity/placebo materials — since incomplete samples or documentation lead to rejection.

This presentation is the 2024 Frequently Asked Questions document of the TİTCK Department of Economic Evaluations and Pharmaceutical Supply Management (Pharmaceutical Supply Management and Export Monitoring Unit). It answers questions frequently submitted by stakeholders in line with legislation and practice; the document is not legally binding and is intended for guidance. It provides definitions covering the Circular dated 20/11/2014 and numbered 1499501, EBS-ESY, the Pharmaceutical Track and Trace System (İTS), export permits for controlled substances, and the dominant and affiliated company definition under Article 195 of the Turkish Commercial Code. Through a set of 14 Q&As, the presentation explains the process for companies other than pharmaceutical wholesalers wishing to export medicinal products. Export may be performed by entities authorized by law or regulation and by companies holding an Authorized Exporter Certificate. Applications may be filed by domestic manufacturers or companies holding licensed human medicinal products in Turkey and/or abroad, and by a single authorized affiliated company (Turkish Commercial Code Article 195; only one affiliated company may be authorized). Applications are submitted via EBS-ESY using the 'Authorized Exporter Certificate' document type to the Pharmaceutical Supply Management and Export Monitoring Unit. No separate document is issued for the responsible manager; submission of the Annex-2 documents requested in the guideline is sufficient. Key practical points for sponsors and companies: the trade registry gazette must state pharmaceutical export among the company's activities; founders' signature circulars and identity documents must be notarized (photocopies are not accepted); an approved GLN document must be provided; officially approved and apostilled or consular-legalized marketing authorization documents from the health authority of the licensing country and a contract with the foreign buyer must be submitted, with documents in Turkish or English (notarized Turkish translations accepted for other languages). For countries not party to the Hague Conference, consular legalization is required. Authorized companies may export only the products covered by their authorization; the Authorized Exporter Certificate alone is not sufficient, as a declaration that the notified products do not contain narcotic or psychotropic substances must also be filed. Pharmaceutical wholesalers are outside the scope of this guideline.

This presentation is the introductory booklet of TİTCK, the Turkish Medicines and Medical Devices Agency, covering its mission, vision, core values and organizational structure, as well as a broad remit spanning clinical trials for human medicinal products, marketing authorization, export certificates, pharmacovigilance, analysis and control, and inspections. The Agency manages a strategic portfolio of medicines, medical devices, cosmetics, traditional herbal medicinal products, advanced therapy products and medicinal nutrition products with more than 1,000 staff including pharmacists, doctors, engineers, chemists and biologists. The President's message highlights the "Value Based Licensing" approach with a prioritization mechanism accelerating authorization of innovative medicines, generics that reduce health expenditures, and products with export potential. Clinical trial applications are submitted in parallel to the Ethics Committee and the Agency; official evaluation times are 12 working days for the Ethics Committee and 22 working days for the Agency. Marketing authorization applications are submitted in CTD format and undergo quality, clinical, pharmacological, bioequivalence and laboratory analysis assessment depending on product type (new, generic, biosimilar/biotechnological, herbal, advanced therapy). Under the prioritization scheme, authorization times are 150 days for high priority, 180 days for priority and 210 days for normal status, excluding clock stop and analysis periods. The presentation also covers the GMP, GCP, GDP and GVP inspection framework (TİTCK's PIC/S membership effective as of January 1, 2018), CPP, GMP/Free Sale and SLSPP export certificates, the MDR/IVDR-aligned medical device legislation, product registration via the Product Tracking System (ÜTS), Pharmaceutical Track and Trace System (İTS) statistics (679 warehouses, 413 manufacturers/importers, 28,788 pharmacies, over 10 billion tracked drug units), and the Electronic Process Management system (ESY), with CTD accepted since 2005 and e-CTD since 2011. For sponsors and CROs, the booklet serves as a general reference on clinical trial and authorization processes, official timelines, prioritization criteria and electronic submission infrastructure.

This presentation is the institutional brochure of the Türkiye İlaç ve Tıbbi Cihaz Kurumu (TİTCK), summarizing its mission, organization and core regulatory activities. TİTCK oversees medicines, medical devices and cosmetics with a staff of over 1,000, and has introduced a "Value-Based Licensing" approach including a priority-setting mechanism to accelerate licensing for innovative, generic-equivalent and export-potential medicines. The organization is structured under deputy presidencies covering pharmaceuticals and pharmacy, medical devices and cosmetics, economic evaluations and laboratory services, inspection services, and support services and information management.

For clinical research, the brochure states that all clinical trials on human medicinal products are evaluated in line with international regulations under a parallel application model to the ethics committee and the Authority; official review timelines are 12 business days for ethics committee assessment and 22 business days for Authority assessment. Medical device clinical trials require Authority permission, while performance evaluation studies of in vitro diagnostic devices are recorded via notification. Licensing dossiers are classified by indication and unit formulation, with licensing timelines of 150, 180 or 210 days depending on priority status (excluding clock-stops and analysis). PIC/S membership (effective 1 January 2018) is highlighted for GMP inspections; GCP inspections are conducted routinely and on a risk basis at Phase I and bioequivalence centres to protect volunteers' rights and data reliability. GDP and GVP inspections, pharmacovigilance activities, analysis and control processes, export certificates (CPP, GMP/Free Sale, SLSPP) and Product Tracking System (ÜTS) registrations are also described.

The brochure shares Turkish Pharmaceutical Tracking System (İTS) statistics: 28,788 pharmacies, 679 wholesalers, 413 manufacturers/importers and 51 reimbursement institutions among 48,000 active stakeholders, with over 10 billion units tracked. Under the Electronic Process Management (ESY) system, licensing applications have been accepted in CTD format since 2005 and e-CTD since 2011. For sponsors and CROs, this brochure serves as a key reference on application procedures, review timelines, priority mechanisms and inspection expectations.

This presentation introduces the adverse reaction reporting form for COVID-19 treatments issued by TİTCK. The form is a structured document enabling healthcare professionals and reporters to report adverse reactions suspected to be associated with medicinal products used in COVID-19 treatment. Reports are to be submitted by e-mail to [email protected] or by fax to 0312 218 35 99.

The form captures patient identifiers such as initials, date of birth/age and sex, together with details of the suspect medicinal product (name, dose, start and end dates of treatment). Products covered include oseltamivir, hydroxychloroquine, azithromycin, favipiravir, lopinavir/ritonavir and tocilizumab. Onset and end dates and outcome of the adverse reaction are requested, along with relevant medical history and concomitant diseases (allergy, diabetes, kidney, liver, lung and heart disease, pregnancy, hypertension, other). Fields are also provided for treatment of the adverse reaction, comments and other observations, concomitant medications (route, dose, start and end dates), and reporter details (name, profession, address, mobile phone, e-mail, reporting date).

For sponsors and CROs, the form illustrates how pharmacovigilance reporting processes were structured during the pandemic; safety teams may use the data elements of such structured forms to benchmark their own safety collection processes.

The presentation introduces the Pharmaceutical Track and Trace System (İTS) of the Turkish Medicines and Medical Devices Agency (TİTCK). İTS is described as a comprehensive digital infrastructure established to track all medicines in the supply chain in Türkiye, ensure access to original and reliable medicines, and prevent pharmaceutical counterfeiting and smuggling; it is highlighted as a pioneering application worldwide. The timeline begins in 2007, followed by web services in 2009, Phase 1 in 2010, Phase 2 in 2012, the İTS Mobile Application in 2014, the Decision Support System in 2019, and the AI-Based Early Warning System in 2025. Slides are dedicated to how the system works and to its legal basis, though no detailed content is provided for these sections. A slide covers the duties of the İTS Unit.

The presentation summarizes TİTCK's Human Medicinal Product Licensing Activities through its organizational chart, the department's general functions, and the licensing process. Core activities include licence revocation and suspension/withdrawal where necessary, variation applications (Type IA, Type IB, Type II), administrative assessment, issuance of the licence, CTD pre-assessment, and scientific assessment covering quality, efficacy, and safety, with requests for additional information/documents where required.

The licensing pathway varies by application type: new drug applications follow GMP priority application, GMP inspection, and GMP certification, then clinical assessment, with a total timeline of 210 days. Generic (equivalent) applications involve quality and bioavailability/bioequivalence (BA/BE) assessment; biosimilar applications additionally include pharmacological assessment; biological/biotechnological products involve preclinical-Phase 1 and clinical assessment. Administrative assessment and licence issuance are completed within 30 days.

The presentation also provides data on products licensed between 2020-2026 and application/approval figures for 2025-2026. As of 29.09.2026, 2025 saw 442 applications and 377 approvals, while 2026 recorded 266 applications and 297 approvals. Locally manufactured generic products represented the highest volume in both years (2025: 233 applications/262 approvals; 2026: 100 applications/210 approvals). For sponsors and CROs, these figures indicate that variable approval timelines and product-type-specific assessment pathways initiated via CTD approval must be factored into planning.

This TİTCK presentation addresses the opening and additional activity application processes for domestic facilities within the remit of the Domestic Facility Inspections Application and Follow-up Unit. The legal basis comprises Articles 508 and 796 of Presidential Decree No. 4 and Law No. 1262 on Pharmaceutical and Medical Preparations. The scope covers application, inspection and authorization processes for manufacturing sites of human medicinal products and their active substances, including clinical research products, imported products, and sites producing foods for special medical purposes. Facility types include drug and active substance manufacturing sites, traditional herbal medicinal product, radiopharmaceutical and advanced therapy medicinal product sites, secondary packaging sites, quality control laboratories, batch release sites, medical gas manufacturing/filling sites and special medical purpose diet food sites. The regulatory framework consists of Law No. 1262, the Regulation on Manufacturing Sites of Human Medicinal Products (published 21.10.2017, Official Gazette No. 30217) and related communiqués. Opening applications are submitted under the document type 'Production Site Opening/Additional Activity Inspection Application'; after deficiencies are resolved, a Chief Inspector, Inspector or Assistant Inspector is appointed for an on-site inspection. Depending on the outcome, approval may be granted (license and responsible manager certificates are issued) or deficiencies are notified. For additional activities, pursuant to Article 11 of the Regulation, changes to manufacturing sites must be reported to the Authority before implementation; major changes fall within the application scope and are evaluated by the inspectors who performed the last general inspection. The outcome may be approval, a request for further information, or an on-site inspection.

This presentation introduces the Product Tracking System (ÜTS) of the Türkiye İlaç ve Tıbbi Cihaz Kurumu (TİTCK). It begins by outlining the medical device life cycle, which comprises pre-market and post-market processes, and describes the ÜTS, operational since 2014. The system provides an infrastructure for registering medical devices, tracking them on a unit-level basis through sales, distribution, procurement and use from production/import onwards, and monitoring maintenance-repair and calibration processes. Registration of cosmetic products and Type1-Type19 biocidal products is also handled through the system.

The ÜTS consists of 8 main and 25 sub-modules covering Product (Registration) Management, Product Movement Management, Clinical Engineering Services Management, and UDI and Alert Process Management. Registered users include sales centers (manufacturers, importers, sales centers/dealers), application centers (optician establishments, hearing device centers, custom orthosis/prosthesis centers, dental prosthetics laboratories), pharmacies, healthcare service providers, medical service providers, medical device service stations, and test-control-calibration organizations. The presentation provides user counts per organization type, for example 34,674 sales centers/dealers, 32,834 pharmacies, and 23,167 public hospitals.

System processes comprise company/institution registration (including MERSIS-registered sole proprietorships and general partnership firms), user definition/authorization/integration, document/product registration, unit-level product movement notifications based on serial and lot numbers, and clinical engineering operations. For sponsors and CROs, the ÜTS demonstrates that device and cosmetic product registration and traceability obligations before the regulatory authority are managed through a single platform, supported by a mobile application for product movement notifications that needs to be integrated into their processes.

The presentation outlines the core duties, authorities, operational flow, and strategic goals of the Department of Clinical Trials at the Turkish Medicines and Medical Devices Agency (TITCK). The Department's responsibilities include approval of Phase 1-2-3 and low-risk scientific drug studies and medical device studies, observational drug and medical device studies, import and storage approvals for research products, and the conduct of bioavailability and bioequivalence studies.

The operational flow is described in four steps: pre-check (format compliance and completeness review of the dossier), ethics committee (scientific and ethical suitability decision), Agency approval (administrative, technical, and methodological dossier review), and continuous monitoring (safety follow-up through periodic reports). Under oversight and safety standards, the presentation highlights bilateral collaborations and regulatory alignment with global authorities such as EMA and FDA, capacity building through training on current international guidelines and standards, legal review of informed consent forms (ICF), and regular follow-up of serious safety reports.

The Department also reviews establishment and activity applications of clinical research ethics committees, periodically audits their working standards and decisions for legal compliance, monitors the regulatory compliance of their decision-making processes, and approves Good Clinical Practice (GCP) training for ethics committee members and investigators. Strategic goals include positioning Türkiye as a preferred clinical research hub, enabling patients' early access to innovative and reliable treatments, strongly supporting domestic drug and medical device development, and fostering a traceable, reliable, and ethical clinical research environment. For sponsors and CROs, the presentation underscores the critical importance of ethics committee decisions and complete dossiers in applications, as well as expectations for continuous safety reporting and monitoring.

This TİTCK presentation, delivered at the BIOEXPO 2026 sector meeting, outlines the regulatory framework for clinical investigations and performance studies with medical devices and in vitro diagnostic (IVD) devices. The foundational principle is that the rights, safety, dignity and welfare of volunteers take precedence under all circumstances, in line with the Convention on Human Rights and Biomedicine, which places the interests of human beings above those of science or society. The framework comprises international conventions (Convention on Human Rights and Biomedicine, Declaration of Helsinki), Law No. 3359 Additional Article 10, Turkish Penal Code Article 90, the Medical Device and IVD Regulations, and GCP and MDCG guidance; the regulations in force are fully aligned with MDR (EU) 2017/745 and IVDR (EU) 2017/746, and all legislation is openly accessible on titck.gov.tr.The presentation covers the rules in MDR Articles 62-80 and IVDR Articles 58-77: Article 62/1 sets out three objectives (verifying design and performance, clinical benefit, and safety and risk); Article 62/4 lists general requirements including authorization by the Authority, ethics committee approval, establishment of the sponsor or legal representative in Türkiye, a valid informed consent form (ICF), and medical care under the responsibility of a physician or dentist. Articles 64-69 provide additional safeguards for incapacitated adults, children, pregnant or breastfeeding women, other vulnerable groups, emergency situations and damage compensation (insurance or equivalent arrangement). The application dossier per Annex XV Chapter II contains the application form, investigator's brochure, clinical investigation plan and other information; under Article 71 the Authority assesses without conflict of interest, with collective expertise and a justified benefit-risk balance — a well-prepared file means faster evaluation, while an incomplete file slows the process. The Authority may inspect research sites under Article 72, and Articles 75-79 address substantial modifications, corrective measures, termination/suspension notifications, coordinated assessment and serious adverse event reporting. Grounds for out-of-scope decisions include the product not being a medical device, the study not qualifying as a clinical investigation, or the product not being beyond prototype stage.Key takeaways for sponsors and CROs include the IVDR side: the definition of leftover samples (MDCG 2025-5) and the invariants of performance studies (Article 59). Nationally, the Medical Device Clinical Investigations Module is actively used for application and notification processes and is under continued development; at the European level, EUDAMED obligations will apply six months after the Commission's notice of the module's functionality is published in the Official Journal of the EU, with MDCG 2021-1 Rev.1 and MDCG 2024-15 governing the transition. The Authority's goal is a regulatory framework that protects volunteers, offers predictability to investors and makes Türkiye attractive for clinical research; questions can be directed to [email protected].

The TİTCK presentation covers the scope and general provisions of the eCTD (Electronic Common Technical Document), the official file format enabling applicants to submit information and documents to health authorities in the licensing and lifecycle processes of medicinal products for human use in a secure, holistic electronic environment compliant with international standards. It ensures that quality, safety and efficacy data potentially comprising tens of thousands of pages are presented in a defined hierarchy and order, reviewed by assessment authorities, and archived in accordance with legal regulations.

The presentation introduces the eCTD v4.0 standards and architecture: a next-generation submission standard developed in line with global regulatory needs and current technological requirements. It abandons the rigid, hard-to-modify folder structures of earlier versions, moving to a flexible, data-driven, internationally harmonized infrastructure for managing information, documents and processes. Documents are handled not merely as files but as trackable data packages within the system via smart tags and identifiers.

For sponsors and CROs, the implications are significant: documents already approved and submitted to the Authority can be reused in subsequent licensing procedures by reference only, without physical re-upload, preventing duplicate submissions, avoiding data confusion, and yielding high storage and archiving savings. Multiple documents in a licensing dossier can be updated, modified or withdrawn simultaneously in a single operational step; administrative material errors in classification, naming or headings can be corrected promptly within the system without recreating and resubmitting the document. Deficiency notifications, requests for additional information and official correspondence between the applicant and the assessment authority are conducted directly on the eCTD infrastructure, minimizing the time and administrative workload in dossier preparation, pre-review and expert assessment, thereby maximizing operational efficiency both inside and outside the Authority.

The TİTCK Drug Licensing Department presentation dated 16.02.2024 (first issued 04.11.2022, third revision) compiles unit-by-unit key considerations for licensing and post-licensing applications. The document is a non-legally-binding guidance aimed at directing stakeholders and lists frequently observed deficiencies from eight units: Pre-Review; Biological and Biotechnological Products; Pharmacological Evaluation; Licensing; Licensed Drugs; Clinical Evaluation; Pre-Licensing Technological Evaluation; and Bioavailability/Bioequivalence Evaluation.

Key procedural expectations include: preparing CTD dossiers in line with the e-submission guidance, covering all applicable modules, with 'Not applicable' stated where information is not required; submitting missing documents via a corrected application rather than a supplementary application (which are not accepted); submitting the second pre-review application within 30 days after CTD pre-assessment deficiencies; apostilled or consular-legalised foreign official documents; responding via EBYS under the same tracking number; selecting the correct unit and document type for variation applications (otherwise the application will not be evaluated and fees will not be refunded); rejection of Type IA applications that fail guideline conditions; document requirements such as SmPC/PIL, Risk Management Plan, Braille and readability testing; keeping GMP certificates current; paying licence fees per the tariff of the year the process is completed; and treating the 30-day information/document response period as calendar days. For bioequivalence dossiers, reference product procurement documentation, comparative in vitro dissolution data, and individual (not averaged) statistical data are expected.

For sponsors and CROs, the presentation underlines that dossier quality and procedural compliance are critical, particularly for variation and response submissions. Meeting requests must be sent only to [email protected]; prioritisation requests for variations causing supply issues only to [email protected], with the required fields (product name, tracking number, unit, urgency justification, stock and monthly consumption data); systemic system issues should be raised with the Information Systems Department.

This presentation is the fourth revision (16.02.2024; first published 04.11.2022) of the Turkish Medicines and Medical Devices Agency (TİTCK) Drug Licensing Department's FAQ document on medicinal product licensing procedures. It answers frequently asked stakeholder questions in line with legislation and practice, but has no legally binding force. The 95-slide Q&A set covers the Pre-Review (CTD) Unit, Biological and Biotechnology Products, Pharmacological Evaluation, Licensing, Licensed Drugs, Priority Assessment, Clinical Evaluation, Pre- and Post-Licensing Technological Evaluation, Advanced Therapy Medicinal Products, and Bioavailability/Bioequivalence Evaluation Units. Key processes include: licensing applications accepted only electronically; no apostille required for GMP certificates published on the official EUDRA GMP and FDA websites; consolidation of application fees into a single item under the 2024 fee schedule; scheduling list ranking based on complete applications confirmed at pre-review, with applications filed before 1 January 2024 prioritised by filing date only; a 6-month obligation to apply after priority decisions (under the updated guideline) with a 20-day appeal window; and 30-day deadlines for deficiency responses and variation notifications, with justified commitments accepted when responses cannot be submitted in time. The document also clarifies that Type IA variation notifications must be submitted within 12 months of implementation and rejected if conditions are not met; Reliance-based variations require the EU/EMA approval letter, unredacted assessment report, and applicant declaration; and each CEP update requires a separate variation submission. For sponsors and CROs, the document serves as a practical guide on e-CTD submissions, SmPC/PIL update procedures (sequencing between Clinical and Pharmacological Evaluation Units), the requirement for current SmPC/PIL approval before licence renewal, clinical study requirements for hybrid and fixed-combination applications, and dissolution studies and reference product procurement documentation for bioequivalence dossiers. It is also noted that advanced therapy medicinal product classification must be obtained before GMP inspection.

This presentation is the third revised (03.11.2023) Frequently Asked Questions document of the TİTCK Department of Pharmaceutical Licensing (first published 04.11.2022). It answers stakeholder questions in line with legislation and practice, is not legally binding, and covers the processes of the units for Pre-Submission Review, Biological and Biotechnological Products, Pharmacological and Clinical Evaluation, Licensing, Licensed Medicines, Priority Assessment, Pre- and Post-Licensing Technological Evaluation, Advanced Therapy Medicinal Products, and Bioavailability/Bioequivalence Evaluation, plus e-CTD submission questions.Key points: licensing applications are accepted only electronically except in cases of force majeure; documents obtained from the EUDRA GMP portal and FDA official websites do not require apostille; GMP certificates are considered valid for 3 years from the inspection date. For variations, Type IA notifications must be submitted within 12 months of implementation; Type IB notifications are deemed accepted if the Agency raises no objection within 30 days; deficiency letters require a response or a commitment with a definite date within 30 days — undated commitments are not accepted. Priority decisions require a licensing/GMP application within 6 months of notification; procedural rejection applies to in-process products not responding within 30 days, with re-application possible. Conditional/exceptional licensing applications are made to the Priority Assessment Unit.Advanced therapy medicinal products are regulated by the Regulation of 27.05.2023, with CTD guidance under development. License renewal does not include quality data updates; SPC/PIL currency applications must be completed before renewal. For integrated medical devices, a commitment to provide notified body opinion is accepted until 31.12.2028. For sponsors and CROs, the presentation is a practical guide for dossier preparation regarding document requirements, translation rules, reliance procedures, and scheduling principles.

This TİTCK Drug Licensing Department presentation dated 27.10.2023 (2nd revision; first issued 04.11.2022) compiles unit-by-unit points to consider in marketing authorisation applications; it is guidance for stakeholders without legal binding force. It covers the Pre-Review, Biological and Biotechnological Products, Pharmacological Evaluation, Licensing, Licensed Medicines, Clinical Evaluation, Pre-Authorisation Technological Evaluation, and Bioavailability/Bioequivalence (BA/BE) Evaluation units. The Pre-Review unit requires complete CTD-format dossiers, corrected rather than supplementary submissions, and a second pre-review application within 30 days of CTD deficiency letters; foreign official documents must be apostilled or consularised. The Biological/Biotechnological unit emphasises variation-type consistency (e.g., Type IA applications failing the conditions are rejected), comparative batch analyses with at least two stability batches plus approved release/shelf-life specifications, annual PMF updates, and separate fees for grouped variations. The Licensing unit lists the licensor 'exclusively' authorisation, Risk Management Plan approval, Braille and readability testing documents, single consolidated responses to all deficiencies within 30 calendar days (no partial commitments), and licensing fee rules. The Licensed Medicines unit recalls pre-renewal approvals (SmPC/PIL, PBRER, quality summary), current GMP certificates, and transfer-of-licence rules. The Clinical unit highlights current, classified literature, posology suited to the pharmaceutical form, and scientific advice procedures; the Technological unit details filter, impurity characterisation, validation and method transfer requirements with ASMF consistency; the BA/BE unit requires reference product procurement documentation and comparative dissolution data presented individually. Three important notes state that variations submitted to the wrong unit/document type will not be evaluated with no fee refund, and that appointment requests ([email protected]) and urgent variation prioritisation requests ([email protected], with product name, tracking number, unit, urgency justification, stock and monthly consumption data) are only accepted via these addresses. For sponsors and CROs, the presentation serves as a practical checklist for pre-submission internal audits to reduce rejection risk.

This TİTCK presentation is the second revised (27.10.2023) Frequently Asked Questions document of the Drug Licensing Department (first issued 04.11.2022, first revision 23.06.2023). Across 100 slides it answers stakeholder questions in line with legislation and established practice; the document is not legally binding and is intended for guidance. It covers the Pre-Review (CTD/e-CTD), Biological and Biotechnological Products, Pharmacological Evaluation, Licensing, Licensed Drugs, Priority Assessment, Clinical Evaluation, Pre- and Post-Licensing Technological Evaluation, Advanced Therapy Medicinal Products, and Bioavailability/Bioequivalence Evaluation units. Key processes: licensing applications are accepted only electronically; foreign official documents must be apostilled or consular-legalised, except current GMP certificates obtained from the official EUDRA GMP and FDA websites, which are exempt; GMP certificates without a stated validity date are accepted for 3 years from the inspection date. Responses to TİTCK information requests must be submitted within 30 days or with a commitment stating a definite date; otherwise the application is rejected on procedural grounds, with 30 days to respond to Article 18 notifications and 45 days to appeal Article 19 substantive rejections. Priority decisions require a licensing/GMP application within 6 months of notification, and priority status ends once the product is licensed. Licence renewal applications must be submitted 9 months before expiry; Module 3 quality data are not updated during renewal. Packaging transition dates are set: warning triangle colours and tamper-evident features by 01.01.2025 for red/green prescription products and by 01.01.2026 for monitored normal prescription products, and multimedia QR-code patient information leaflets for visually impaired users by 01.01.2026; QR-code leaflet text must be updated within 30 days of approval. The Advanced Therapy Medicinal Products Licensing Regulation was published in the Official Gazette on 27.05.2023, with CTD guidance under development. For sponsors and CROs, the document serves as a unit-by-unit practical guide on dossier preparation, variation types (IA/IB/II), duplicative applications, SmPC/PIL updates, scientific advice, and commitment procedures.

This presentation is the 23 June 2023 revised document of the TİTCK Drug Licensing Department, compiling unit-by-unit points that sponsors must consider in marketing authorisation and variation applications. The document is non-binding guidance intended to direct stakeholders and lists common deficiencies and errors across eight evaluation units (Pre-Review, Biological and Biotechnological Products, Pharmacological Evaluation, Licensing, Licensed Medicines, Clinical Evaluation, Pre-Authorisation Technological Evaluation, and Bioavailability/Bioequivalence Evaluation). The Pre-Review section emphasises consistency across all CTD modules, submitting a corrected application instead of a supplementary one, responding to deficiency letters with a second pre-review application within 30 days, and providing apostilled or consular-legalised official documents. The Biological and Biotechnological Products unit details variation type consistency (Type IA/IB/II), comparative batch analysis results, at least two batch stability datasets, and use of the reference medicinal product rather than a reference standard in biosimilar comparisons. The Licensing unit focuses on administrative processes such as the authorisation letter containing the wording «exclusively», Risk Management Plan approval, Braille documentation, the 30-day response period, and tracking of fee differences. The Licensed Medicines unit summarises internal unit approvals required before renewal applications, currency of GMP certificates, and routing nitrosamine-related applications to the correct unit per the 02.09.2022 announcement. The document also notes that variation applications submitted to the wrong unit or document type will not be evaluated with no fee refund; appointment requests must be sent only to [email protected] and urgent variation prioritisation requests only to [email protected], including product name, tracking number, unit name, urgency justification, stock and monthly consumption data. For sponsors and CROs, the document serves as a practical checklist to prevent application rejections and timeline delays.

This TİTCK presentation (v01, 23 June 2023) compiles frequently asked questions addressed to the units of the Drug Licensing Department, covering the Pre-Submission Review, Biological and Biotechnological Products, Pharmacological Evaluation, Licensing, Licensed Drugs, Priority Assessment, Clinical Evaluation, Pre- and Post-Licensing Technological Evaluation, Advanced Therapy Medicinal Products, and Bioavailability/Bioequivalence Evaluation units. The document is guidance-oriented and has no legal binding force.

Key procedural points include: licensing applications are accepted only electronically; apostille is not required for GMP certificates published on the official EUDRA GMP and FDA websites; GMP certificates without an expiry date are considered valid for 3 years from the inspection date. Type IA variation notifications must be submitted within 12 months following implementation, with immediate notification required for certain Type IA minor variations; for Type IB notifications, the submission is deemed accepted if the Authority raises no objection within 30 days. Where the 30-day deadline for responding to deficiency letters is insufficient, a commitment stating the submission date is accepted; requested data must be provided in a single submission. After a priority decision, the licensing/GMP application must be made within 6 months, and appeals must be filed in writing within 20 days. Licence renewal applications are submitted at least 9 months before expiry; the guideline sets a 60-day period for SmPC/PL approval.

For sponsors and companies, the presentation clarifies dossier placement (e.g., RMP in Module 1.8.2; in-vitro dissolution studies for BY/BE waivers in Module 5.3.1.3), rules for generic and hybrid applications, ASMF/VAMF/PMF requirements, change and variation procedures, and packaging/QR code/Braille transition timelines (31 December 2024). It also notes that the Regulation on Advanced Therapy Medicinal Products was published in the Official Gazette on 27 May 2023, with CTD guidance work ongoing.

This presentation is the TİTCK Pharmaceutical Licensing Department's Frequently Asked Questions document, first published on 04.11.2022, answering stakeholder questions in line with legislation and established practice; it carries no legal binding force. The document covers questions across the twelve units of the department: Pre-Review, Biological and Biotechnological Products, Pharmacological Evaluation, Licensing, Licensed Drugs, Priority Evaluation, Clinical Evaluation, Pre- and Post-Licensing Technological Evaluation, Advanced Therapy Medicinal Products, and Bioavailability/Bioequivalence Evaluation units. The Pre-Review section clarifies that licensing applications are accepted only electronically; apostille is not required for GMP documents published on the EUDRA GMP and FDA official websites; a certificate of analysis is not required where the CEP mentions the packaging material; equivalent medicinal product applications may reference a reference product whose data exclusivity period has not expired; GMP certificates without a validity date are accepted as valid for 3 years from the inspection date; VAMF submission is mandatory for vaccine applications; sworn Turkish translations are required for Module 1 documents; submission of the readability test protocol and commitment suffices at pre-review; and for integrated medical devices, CE certification can be committed until 26 May 2024. For biologicals, process validation should be performed on at least 3 consecutive commercial batches, comparability studies should use at least 3 batches of different ages of the reference product, PMFs must be updated annually, and at least 6 months of stability data is expected for active substance manufacturing site changes. The Licensing and Licensed Drugs units clarify that deficiencies must be answered within 30 days in a single submission with commitments specifying exact dates; variation-type applications must state in the cover letter whether cancellation of the current license is requested; Type IA notifications must be submitted within 12 months of implementation; and 'Reliance' variations require the EU/EMA approval letter, the unredacted assessment report, and a licence holder declaration that the scope is fully identical. Priority decisions require the license/GMP application within 3 months, with appeals submitted in writing within 20 days. The bioequivalence unit confirms the three-pH dissolution requirement with scientific justification for exceptions, and that bioequivalence studies are requested for modified-release injectable suspensions. For sponsors and CROs, the presentation provides a practical, unit-by-unit guide on language, apostille, GMP, stability, and variation expectations in CTD dossier preparation.

The TİTCK Licensing Department presentation dated 04.11.2022 compiles, on a unit-by-unit basis, the points applicants should heed in licensing and post-licensing submissions. The document is guidance-oriented and has no legally binding force. It lists common deficiencies and errors across the Pre-Review, Biological and Biotechnological Products, Pharmacological Assessment, Licensing, Licensed Medicines, Clinical Assessment, Pre-Licensing Technological Assessment, and Bioavailability/Bioequivalence (BY/BE) Assessment units. The Pre-Review unit section emphasizes that CTD dossiers must contain all modules per application type, that corrected submissions after deficiency letters must be made within 30 days, that supplementary submissions are not accepted, and that official foreign documents must be apostilled or consulate-approved. The Biological and Biotechnological Products unit highlights consistency of the variation application type, rejection of Type IA applications where the biological test-method condition is not met, and expectations such as quantitative data and legible chromatograms/gel images. The Licensing unit covers the licensor's 'exclusively' authorization document, Risk Management Plan approval, Braille documentation, current GMP certificates, licence fee accrual and tracking rules, and the requirement to respond to all deficiencies in a single submission, with a separate document for each deficiency letter. The Licensed Medicines unit draws attention to the requirement not to file renewal applications before PYRDR approval, to select correct document types, and to follow the nitrosamine announcement (02.09.2022) for unit routing. The Clinical Assessment, Pre-Licensing Technological Assessment, and BY/BE sections cover current literature, posology appropriate to the pharmaceutical form, reference product SPC/PIL submission, filtration, compatibility, stability and validation details, reference product procurement documentation, and comparative dissolution testing. The critical takeaway for sponsors and service providers is the important note at the end: if a variation application is submitted to the wrong unit or with the wrong document type, it will not be taken into assessment and the application fee will not be refunded.