Turkey’s New Clinical Trial Safety Reporting Framework: Preparing for the Transition to Electronic SUSAR Reporting

Turkey is introducing significant changes to clinical trial safety reporting that will affect sponsors conducting studies in the country. Following recent amendments to the Clinical Trials Regulation, the Turkish Medicines and Medical Devices Agency (TİTCK) has revised three key clinical trial guidelines and launched a new National SUSAR Module designed to modernize the management and submission of safety information.

While some of the updates are administrative in nature, others will require sponsors to review their pharmacovigilance processes, system capabilities, and local compliance strategies ahead of an important transition deadline in July 2026.

 

What Has Changed?

The revised guidelines introduce updates to clinical trial application procedures and safety reporting requirements, with the most significant change being the implementation of a National SUSAR Module within Turkey’s Clinical Trials Module.

The revised framework aligns safety reporting requirements with internationally recognized standards, including ICH E2B(R3) and the European Union Clinical Trials Regulation (EU CTR) 536/2014. This reflects Turkey’s ongoing efforts to modernize its clinical trial environment and support more structured electronic reporting of safety data.

Transition to Mandatory XML-Based SUSAR Reporting

A key feature of the update is the move towards electronic SUSAR submissions through the new National SUSAR Module.

Until 1 July 2026, sponsors may continue submitting domestic SUSARs either through the existing Clinical Trials Module using PDF CIOMS forms or through the new SUSAR Module using XML submissions. Following the transition period, XML submissions via the SUSAR Module will become mandatory, and PDF-based submissions will no longer be accepted.

For sponsors, this is more than a technical change. Organizations will need to ensure that safety databases, reporting workflows, and vendor arrangements can support E2B(R3)-compliant electronic submissions within the required timelines.

Sponsors that wait until the final stages of the transition period may face challenges related to system validation, process updates, and staff training. Early preparation can help reduce implementation risks and avoid potential disruptions to ongoing clinical development programe.

 

New Requirements for Foreign SUSAR Reporting

The revised guideline also introduces a new requirement for six-monthly line listings of foreign SUSARs.

These listings must be submitted for each investigational medicinal product, provided in English through the Clinical Trials Module, and submitted in parallel through additional national channels.

Although periodic foreign SUSAR reporting is not uncommon globally, the introduction of country-specific submission requirements increases the need for effective coordination between global pharmacovigilance teams, CROs, local affiliates, and regulatory partners.

Sponsors should review existing responsibilities and reporting pathways to ensure that all required safety information can be collected, reconciled, and submitted within the required timelines.

 

Beyond Compliance: The Operational Impact for Sponsors

The changes introduced by TİTCK highlight a broader trend across regulatory authorities towards increased digitalization and enhanced oversight of clinical trial safety reporting.

For sponsors managing multinational clinical trials, the practical impact extends beyond regulatory compliance.

Several key questions should be considered:

• Can existing pharmacovigilance systems generate E2B(R3)-compliant XML files for submission?
• Are local reporting procedures aligned with Turkey’s revised requirements?
• Have responsibilities for foreign SUSAR line listings been clearly assigned?
• Do vendors and service providers have the necessary capabilities to support the transition?
• Are internal teams adequately trained on the new reporting pathways?

Addressing these questions early can help organizations avoid last-minute implementation challenges while maintaining consistent oversight of clinical trial safety obligations.

 

What Sponsors Should Do Now

With the transition deadline approaching, sponsors should consider taking several proactive steps:

• Conduct a gap assessment of current Turkey-specific safety reporting processes
• Evaluate readiness for XML-based SUSAR submissions
• Review and update SOPs, work instructions, and training materials
• Confirm responsibilities for foreign SUSAR reporting and reconciliation activities
• Engage with pharmacovigilance and regulatory partners to ensure alignment on implementation timelines

Organizations that begin preparations now will be better positioned to manage the transition efficiently and maintain compliance as the new framework becomes fully operational.

 

Looking Ahead

Turkey’s latest updates represent one of the most significant changes to its clinical trial safety reporting framework in recent years. By introducing structured electronic reporting and expanding safety reporting obligations, TİTCK is moving towards a more digital and internationally aligned regulatory environment.

For sponsors, the changes provide an opportunity to strengthen safety reporting processes, improve operational readiness, and ensure continued compliance in an evolving global regulatory landscape.

 

How PrimeVigilance Can Help

As regulatory requirements continue to evolve across global markets, sponsors need practical support that combines local regulatory expertise with global pharmacovigilance capabilities.

PrimeVigilance helps sponsors navigate changing clinical trial safety requirements through regulatory intelligence, local compliance support, clinical trial safety services, and global pharmacovigilance solutions. Our teams work closely with sponsors to assess regulatory impact, implement process changes, and maintain compliance across complex multinational development programe.

To discuss how Turkey’s new clinical trial safety reporting requirements may affect your studies, contact our experts.

 

Resources

• Guideline on Clinical Research Applications Submitted to Ethics Committees
• Guideline for Clinical Trial Applications Submitted to the Clinical Research Department of the Turkish Medicines and Medical Devices Agency (TİTCK)
• Guideline on safety notifications in clinical trials