Quote from VigiServe Admin on November 29, 2020, 7:26 AM

The pharmacovigilance (PV) system in **Turkey** is highly developed and closely aligned with **EU Good Pharmacovigilance Practices (GVP)** modules, as the **Turkish Medicines and Medical Devices Agency (TITCK – Türkiye İlaç ve Tıbbi Cihaz Kurumu)** has harmonized its framework with EU regulations (Regulation (EU) No 1235/2010 and Directive 2011/84/EU amendments) to support EU accession aspirations and facilitate mutual recognition. Turkey is a full WHO PIDM member, contributing to VigiBase, and TITCK operates the **Turkish Pharmacovigilance Center (TÜFAM)** for national coordination, signal detection, risk management, inspections, and safety communications.

Key documents (as of 2025–2026 updates):
- **Guideline on Good Pharmacovigilance Practices (İyi Farmakovijilans Uygulamaları – IFU Kilavuzu)** — Modular structure mirroring EU GVP (e.g., Module II PSMF, Module V RMP, Module IX Addendum I Training/Safety Communication, Module VIII Safety Communication, Crisis Management Guideline).
- **Guideline on Pharmacovigilance System** (updated November 2022, with ongoing revisions).
- **Guideline on Safety Notifications in Clinical Trials** (updated 2025, effective May 2025, with additions for fatal SAEs).
- Electronic reporting via TITCK portals (e.g., for ICSRs, PSURs).

**Legal Framework and Governance**
- Regulated under the **Pharmaceuticals and Medical Devices Law** and TITCK regulations.
- TITCK/ TUFAM handles national PV, including the Pharmacovigilance Advisory Committee for reviews.
- MAHs must maintain compliant PV systems; TITCK conducts GVP inspections (routine/annual metrics published, e.g., 2024–2025 reports).

**Organization and Personnel**
- Marketing Authorization Holders (MAHs)/license holders must establish and maintain a PV system per Turkish GVP.
- Appoint a **Qualified Person for Pharmacovigilance (QPPV)**: Mandatory; must be a qualified professional (often medical/pharmacy degree + experience), resident in Turkey (or EU-equivalent for some cases), serving as the primary TITCK contact 24/7.
- **PV System Master File (PSMF)**: Mandatory (per GVP Module II, Rev 1 or later, e.g., FVK-KLVZ-05 Nov 2022); describes the PV system in detail, must be maintained/updated and available for TITCK inspections (no mandatory registration, but accessibility required).

**Individual Case Safety Reports (ICSRs) – Post-Marketing**
- MAHs report suspected ADRs (serious/non-serious, medication errors, quality issues) to TÜFAM via electronic systems or forms (E2B compatible).
- Timelines (aligned with EU/ICH):
- **Serious ICSRs** (unexpected or expected with increased frequency/severity): Expedited within **15 calendar days** of receipt.
- **Non-serious ICSRs**: Within **90 calendar days** or in periodic reports.
- Foreign ICSRs: Included in periodic reports if relevant to benefit-risk.

**Periodic Benefit-Risk Evaluation Reports (PBRER/PSUR)**
- MAHs submit PSURs/PBRERs (ICH E2C(R2) format) to TITCK.
- Frequency: Typically every 6 months for the first 2 years post-authorization, annually thereafter, or as per EURD list/TITCK-specified (during renewals/variations/safety concerns).

**Risk Management Plans (RMP)**
- Required for new active substances, biologics, high-risk products, or specific concerns (per GVP Module V).
- Submit RMP with pharmacovigilance plan and risk minimization measures; updates for significant changes or new risks.
- Turkish-specific adaptations or reliance on EU RMPs possible.

**Signal Management and Emerging Safety Issues**
- MAHs continuously monitor data and notify TITCK of validated signals or emerging concerns promptly.
- TITCK leads national signal detection; crisis management and safety communication guidelines apply (e.g., Module VIII).

**Clinical Trials-Related Safety Requirements**
Clinical trials require TITCK approval (via Clinical Trials Department) and ethics committee review, per **Clinical Trials Regulation** and GCP-aligned guidelines.
- Sponsors monitor safety and report to TITCK.
- **Suspected Unexpected Serious Adverse Reactions (SUSARs)**: Expedited reporting (aligned with ICH E2A; typically **7–15 days** for serious unexpected, faster for fatal/life-threatening).
- Fatal SAEs now require a dedicated cover letter (2025 update to Guideline on Safety Notifications in Clinical Trials, effective May 2025).
- **Development Safety Update Reports (DSURs)**: Annual/periodic required (ICH E2F format), especially for ongoing trials.
- No direct EudraVigilance access; reports via TITCK channels (electronic/forms). Sponsor responsibility for monitoring, causality assessment, and submission to TITCK/ethics committees.

**Additional Monitoring / Other Aspects**
- No black triangle scheme, but active surveillance for high-risk products (e.g., biologics/vaccines).
- Emphasis on training materials, safety communication, inspections, and electronic tools.
- Reporting encouraged from HCPs/patients/MAHs; compliance enforced via notices and audits.

Turkey's PV framework is robust, EU-harmonized, and enforcement-focused (e.g., GVP inspections, non-compliance actions), making it one of the most mature in the region. For precise, product- or trial-specific details (e.g., latest IFU Kilavuzu modules, forms, or 2025 clinical trial guideline updates), consult **TITCK** directly via titck.gov.tr (Pharmacovigilance/Clinical Trials sections, guideline downloads, or TÜFAM contacts), as requirements evolve (e.g., 2025 safety notification updates). Companies often use local QPPV/consultants for compliance in Turkey.

 

Contact Details:

E-Mail: TUFAM@iegm.gov.tr

Fax:      0(312)309 71 18 

Tel:       0(312) 309 53 97

​Post:

Pharmacovigilance Association Center/ İÇERENKÖY MAH.

ÜSKÜDAR- İÇERENKÖY YOLU CAD. NO:8 D:12

ATAŞEHİR / İSTANBUL

TURKEY

 

Pharmacovigilance Modules

Pharmacovigilance Guideline