TİTCK Approval: Turkey's 3–4 Month Timeline

TİTCK (Türkiye İlaç ve Tıbbi Cihaz Kurumu, the Turkish Medicines and Medical Devices Agency) is Turkey’s competent authority for clinical trial approval, reviewing drug and device studies in parallel with an accredited Ethics Committee. Both reviews must conclude favorably, submitted through the EBS electronic application system, before a trial can start.

This guide walks through the TİTCK/Ethics Committee approval pathway, the EBS electronic submission system both tracks run through, typical timelines, and the safety-reporting overhaul that took effect on 15 May 2026 — including the new national SUSAR Module. It’s part of CASRAI’s series on national clinical trial regulatory pathways; see the related-guides list at the end for sibling country write-ups.

Who Reviews What: TİTCK and the Ethics Committee

Every interventional clinical trial conducted in Turkey needs two separate favorable outcomes before enrollment can begin:

Ethics Committee (EC) approval — an independent, TİTCK-accredited Ethics Committee evaluates the scientific rationale, participant protection measures, informed consent materials, and risk-benefit balance of the protocol.
TİTCK authorization — TİTCK’s own scientific/technical review evaluates the investigational product dossier (quality, non-clinical and clinical data package), the protocol, and the overall regulatory compliance of the application.

Sponsors submit to both tracks through the same electronic system, and TİTCK’s own process documentation describes the two evaluations as running in parallel once a complete application is in the system, rather than as two fully sequential, non-overlapping reviews — though in practice the Ethics Committee opinion is a required, load-bearing input to TİTCK’s own final decision, so the two tracks are tightly coupled rather than fully independent. Sponsors should not treat EC approval and TİTCK authorization as separable milestones that can be pursued on different timelines; both are needed, and TİTCK will not authorize a trial without the corresponding favorable EC opinion in hand.

Timeline: Roughly 3-4 Months Overall

Reported total timelines for a straightforward Phase I-III interventional drug trial application — from initial submission through both EC and TİTCK sign-off — typically run around three to four months, assuming a complete, deficiency-free dossier and no major protocol amendments requested mid-review. This is broadly competitive with other major single-country pathways CASRAI has covered in this series (see the related guides below), though sponsors should build in contingency for at least one round of clarification questions from either the EC or TİTCK, which is common and will extend the timeline beyond the baseline estimate.

As with most national systems, the clock resets or pauses when TİTCK or the EC issues a formal request for additional information — the sponsor’s response time is not counted against the regulator’s review clock, so incomplete initial submissions are one of the most common (and avoidable) sources of delay.

EBS: The Electronic Submission Backbone

All clinical trial applications, amendments, safety reports, and correspondence with TİTCK go through EBS (Elektronik Başvuru Sistemi — Electronic Application System), TİTCK’s electronic submission platform, including its Clinical Trials Module. Sponsors and CROs submit the application dossier, respond to deficiency letters, and file ongoing safety reports through this system rather than by paper or ad hoc email (with one narrow exception for certain safety-reporting correspondence, covered below). Practically, this means a sponsor’s Turkish regulatory affairs contact or local CRO needs an active EBS account and familiarity with the platform’s document-type taxonomy before submission — misfiling a document under the wrong document type inside EBS is a routinely cited cause of avoidable back-and-forth with reviewers.

Core scientific documents — the protocol and Investigator’s Brochure — are generally accepted in English. Participant-facing materials (the informed consent form, patient diaries) and the Ethics Committee application forms themselves must be in Turkish. Sponsors running multi-country trials should plan translation and in-country linguistic review as a critical-path item, not an afterthought, since Turkish-language EC materials are a hard submission requirement, not a nice-to-have.

The May 2026 Safety Reporting Overhaul: New Guideline and the National SUSAR Module

TİTCK updated its safety-reporting requirements for clinical trials with a revised Guideline on Safety Reports in Clinical Trials, which entered into force on 15 May 2026. The centerpiece of the update is a new National SUSAR Module, built as a sub-module of the existing Clinical Trials Module inside EBS, specifically for collecting, recording, and analyzing Suspected Unexpected Serious Adverse Reactions (SUSARs) arising from trials conducted in Turkey. TİTCK built the module’s data structure around ICH E2B(R3) (the international standard for electronic transmission of individual case safety reports) and in alignment with the reporting logic of EU Clinical Trials Regulation 536/2014, giving Turkey a domestic SUSAR database that follows internationally recognized case-safety-report architecture rather than a bespoke local format.

Key operational provisions sponsors and CROs running Turkish sites need to plan around:

XML becomes mandatory from 1 July 2026. Domestic SUSAR notifications had a transition window where either the structured XML format or the older CIOMS-form-plus-Clinical-Trials-Module route was accepted; as of 1 July 2026, XML submission through the dedicated SUSAR Module is the only accepted route for domestic SUSARs.
Foreign-originating SUSARs (safety events from the same investigational product occurring at trial sites outside Turkey) are handled differently: sponsors submit sequential (periodic) listing reports covering rolling six-month periods through the Clinical Trials Module, in a specified listing format, rather than individual case reports per event.
A narrow dual-channel filing step remains for sequential listings: sponsors prepare the English-language sequential listing, email it to TİTCK’s designated safety-reporting inbox ([email protected]), and separately upload the PDF version into the EBS-ESY Clinical Trials Module under the correct safety-report document type. This is one of the few places in the Turkish system where a submission still requires an email step alongside the electronic portal filing, so it’s worth flagging explicitly in a sponsor’s local SOP.

Sponsors already reporting SUSARs from other jurisdictions in ICH E2B(R3)-compliant XML (as required for EMA’s EudraVigilance or similar systems) should find the underlying data structure familiar, even though the Turkish module is a separate, national-only database rather than a shared regional one — a SUSAR reported into EudraVigilance or FDA’s FAERS does not automatically satisfy the Turkish domestic reporting obligation, and vice versa.

Practical Checklist for Sponsors Planning a Turkish Site

Confirm your CRO or in-country regulatory contact has active EBS credentials and current familiarity with the Clinical Trials Module’s document-type taxonomy before the submission date, not after a deficiency letter arrives.
Budget translation time for Turkish-language informed consent materials and EC application forms as a critical-path item alongside protocol finalization, not after it.
Plan for the 3-4 month baseline timeline plus contingency for at least one clarification round from TİTCK and/or the Ethics Committee.
If your trial has already been generating SUSARs prior to 15 May 2026, confirm with your safety/pharmacovigilance team that domestic case reports have moved to XML-only submission through the SUSAR Module as of 1 July 2026, and that foreign-originating events are being tracked separately for six-month sequential listings.
Route sequential-listing safety correspondence through both the [email protected] inbox and the EBS-ESY portal upload — treat this as a two-step filing, not an either/or.

Frequently Asked Questions

Is TİTCK approval required for medical device trials as well as drug trials?

Yes. TİTCK is the competent authority for both human medicinal products and medical devices in Turkey, and both categories of clinical investigation go through TİTCK’s review alongside Ethics Committee approval, though the specific dossier requirements differ by product category.

Can the Ethics Committee and TİTCK reviews really happen at the same time?

The two tracks are designed to run alongside each other once a complete application is filed, but they are not independent of one another — TİTCK’s authorization decision depends on having a favorable Ethics Committee opinion in hand, so sponsors should plan for the two to be tightly coupled rather than assume EC approval can lag TİTCK’s decision or vice versa.

What happens to SUSARs reported before 15 May 2026 — do they need to be resubmitted under the new module?

This guide describes the forward-looking requirements that took effect with the updated guideline; sponsors with an existing safety-reporting history in Turkey should confirm transition and back-reporting expectations directly with TİTCK or their local pharmacovigilance/regulatory affairs contact, since transitional handling of pre-existing case data is the kind of procedural detail that is best confirmed against TİTCK’s current published guidance rather than assumed.

Does a SUSAR filed in EudraVigilance or FAERS also satisfy the Turkish reporting obligation?

No. The National SUSAR Module is a separate, Turkey-specific database. Even though it was built to ICH E2B(R3) structure for consistency with international standards, filing in another region’s pharmacovigilance database does not substitute for the domestic Turkish submission if the trial has a Turkish site.

Related Country Regulatory Pathway Guides

This guide is part of CASRAI’s ongoing series covering national clinical trial regulatory pathways. See also:

This guide reflects TİTCK’s published guidance and industry regulatory-affairs reporting as of July 2026. Regulatory timelines and procedural requirements are subject to change; sponsors should confirm current requirements directly against TİTCK’s official published guidance before finalizing a submission plan.