FAQ: Clinical Trials in Turkey

Comprehensive Guide to Medical Device and Pharmaceutical Trials in Turkey

REGULATORY & COMPLIANCE

Q1: Is clinical data generated in Turkey accepted by the EMA (Europe) and FDA (USA)?

A: Absolutely. The Turkish Medicines and Medical Devices Agency (TİTCK) is an active member of ICH (International Council for Harmonisation). Turkey’s regulatory framework is fully aligned with EU Directives and global GCP standards. Data generated in Turkish sites is routinely used for global regulatory submissions (FDA/EMA approvals) and CE marking.

Q2: Is Turkey a valid location for Clinical Investigations under EU-MDR?

A: Yes. Turkey has been fully harmonized with the European Union Medical Device Regulation (EU-MDR). Clinical data collected in Turkey is valid for conformity assessment and CE marking in Europe. CROTURK conducts all device investigations in strict compliance with ISO 14155 standards.

Q3: What is the regulatory approval timeline in Turkey?

A: Turkey offers a robust and predictable regulatory pathway. The process is sequential: applications must first be approved by the Ethics Committee (EC) before the Ministry of Health (TİTCK) begins its review. Despite this step-by-step procedure, the total timeline remains highly competitive, averaging 3 to 4 months for full approval. CROTURK accelerates this timeline by preparing both dossiers simultaneously, ensuring immediate MoH submission the moment EC approval is received.

OPERATIONS & LOGISTICS

Q4: Do submission documents need to be translated into Turkish?

A: Core scientific documents such as the Protocol and Investigator’s Brochure (IB) are generally accepted in English by the Ministry of Health. However, all patient-facing documents (Informed Consent Form, Diaries) and Ethics Committee application forms must be in Turkish. CROTURK’s in-house medical writing team handles all necessary certified translations and adaptations.

Q5: How complicated is the importation of IMPs (Investigational Medicinal Products) or Medical Devices?

A: Importation is streamlined but requires specific authorization. We obtain an “Import License" from the MoH for each study, which allows for duty-free importation of study drugs, devices, and kits. Our logistics team manages the customs clearance process to ensure supplies reach the sites without delay.

Q6: Why is patient recruitment faster in Turkey compared to the EU?

A: Turkey has a centralized healthcare system where single centers handle enormous patient volumes. This benefits all types of trials:

- For Common Conditions: Recruitment for high-prevalence diseases (Diabetes, Hypertension, Respiratory) is exceptionally fast due to heavy patient traffic in outpatient clinics.
- For Complex/Rare Conditions: Centralized referral systems allow us to quickly pinpoint specific patients. Consequently, CROTURK consistently meets or exceeds enrollment targets across all major therapeutic indications, not just in niche areas.

QUALITY & OVERSIGHT

Q7: How does CROTURK ensure data quality and site compliance?

A: We employ a risk-based monitoring approach combined with 100% Source Data Verification (SDV) when required. Our CRAs (Clinical Research Associates) act as "Site Managers," visiting sites frequently to ensure protocol adherence. We are a member of EUCROF (European CRO Federation), guaranteeing that our operational standards match those of any premier European CRO.

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