Transparent & Predictable Supply Architecture: Concrete Cooperation Steps Through the Congress Platform

Türkiye is emerging as a key actor in strengthening access to safe, quality, and effective medicines and approved medical devices across a wide geography stretching from Africa, the Middle East, and Asia to the Balkans. This role matters not only for health outcomes; it also creates critical value by supporting predictability in supply flows, stability in market confidence, and, consequently, an enabling environment for investment appetite. In a period when cross-border trade and procurement are accelerating, a shared need is becoming increasingly clear: interoperability among regulatory systems, prevention of counterfeit or unregistered product flows, strengthened inspection capacity, and the institutionalization of a post-marketing surveillance culture.

Another—and increasingly visible—dimension of this need is the acceleration of trade and the strengthening of the investment climate alongside secure supply. Traceability, inspection, and post-marketing oversight capacity not only reduce risk; they also improve predictability in supply planning, lower regulatory uncertainty, and place production and supply-side decision-making on a more robust footing.

Within this framework, Türkiye’s national authority, the Turkish Medicines and Medical Devices Agency (TİTCK), offers a model that is aligned with global standards and implementable within regional realities. Its recognition by the World Health Organization as “Maturity Level 3 (ML3)”; PIC/S membership for GMP inspections; ICH regulatory membership for harmonization of medicines regulation; full membership in the GEON/OMCL network on the laboratory side; and quality assurance frameworks such as ISO 9001, ISO/IEC 27001, and ISO 17025 demonstrate that the institution is not only an authority that grants approvals, but a regulatory mechanism that monitors and measures the market. This accumulated capability positions Türkiye as a referenced regulatory and traceability capacity in the region.

What makes a tangible difference in the field is that inspection capacity is not limited to pre-supply GMP processes, but is integrated into a lifecycle-wide oversight logic. In this context, the introduction and launch of the Continuous Inspection (CI) approach will take place within the scope of the 6th Medical Supply Chain Management Congress; the model’s scope, operating principles, and stakeholder interaction architecture will be shared at the congress. CI offers a digital inspection approach that supports product safety and effectiveness across the supply chain from raw material to end user, integrating pre- and post-supply processes. While operating in alignment with the Agency’s existing tracking systems, this structure can also “talk to” stakeholder systems; supported by artificial intelligence and data analytics, it accelerates inspection cycles through objective and sustainable inspection scenarios, strengthens risk-based prioritization, and establishes a continuous quality control layer across the supply chain.

Another factor reinforcing the on-the-ground impact of this institutional capacity is the completion of this foundation with a digital backbone. In Türkiye, medicines market safety is supported by an architecture in which traceability, inspection, and post-marketing oversight components work in concert. The Pharmaceutical Track and Trace System (İTS) assigns a unique DataMatrix code to each pack and tracks it from production to the patient, reducing counterfeiting, accelerating recalls, and lowering misuse risk.

When the traceability infrastructure provided by İTS is complemented by analytical layers such as PREDIS (AI-Based Early Warning System), the system evolves from one that merely “records the past” into a capacity that makes risks visible in advance. Using TİTCK datasets, PREDIS detects anomalies in medicines and equivalent groups, analyzes availability conditions, and provides decision support by generating forward-looking forecasts.

For medical devices and cosmetics, the Product Tracking System (ÜTS) records the lifecycle from manufacturer to end user and unifies a fragmented market on a single screen. Both systems address data sovereignty concerns through architectures that do not store personal data and through compliance with information security standards.

Pharmacovigilance and Rational Use of Medicines activities led by TÜFAM(Turkish Pharmacovigilance Center), together with medical device vigilance activities conducted by the Medical Device Inspection Department, strengthen feedback mechanisms regarding the performance of human medicinal products and medical devices and adverse events associated with these products. This makes product safety monitoring systematic and supports a regulatory culture that “monitors the product lifecycle.” The monitoring and inspection of 390 manufacturing facilities in Türkiye (API, finished product, traditional herbal, foods for special medical purposes, etc.) under the regulatory framework, and the subjecting of products on the market to market surveillance and inspection, demonstrate that this approach is not merely an aspiration; it has been translated into the desired capacity at scale in the field.

We believe the value of this accumulated experience for countries across the region lies in its ability to translate the goal of “high standards” into accessible, actionable steps.

In the fight against counterfeit and unregistered product circulation, İTS provides a national-scale core, while ÜTS enables item-level traceability for medical devices from production/import to the end user. In countries where the pool of inspectors is limited, capacity can be rapidly increased through PIC/S-aligned joint inspection calendars and inspector training programs, and—within the scope of medical devices—through participation in EU joint inspection group mechanisms. In this context, integrated digital oversight models similar to CI can accelerate capacity building by enabling more precise use of inspection resources via risk-based planning and data analytics. To disseminate pharmacovigilance and medical device vigilance culture, a notification–analysis–action cycle supported by TÜFAM (pharmacovigilance) and ÜTS (medical device vigilance) can be made operational in a short time.

The economic dimension of this convergence is also becoming increasingly visible. According to data shared in İEİS’s Türkiye Pharmaceutical Industry 2024 Report, pharmaceutical exports grew by 3.1% in 2024, reaching USD 2.3 billion and surpassing the previous year’s record. Over the 2015–2024 period, while Türkiye’s total exports grew by 73.4%, the 109.3% increase in pharmaceutical exports indicates that the sector outperformed the national average. The rise in the export-to-import coverage ratio for pharmaceuticals from 22% to 37% in the same period points to a critical reality: capacity areas such as traceability, inspection, and lifecycle oversight are essential not only for safety and accessibility, but also for a predictable foundation that supports investment and trade flows.

There are working components in Türkiye—and they are candidates to become building blocks of a regional whole: a framework where each country remains anchored in its own legislation and data, while a common language is established in inspections, monitoring systems can interpret one another, and laboratory results can be compared.

As the Organizing Committee, we believe such convergence will strengthen a shared foundation in inspection, monitoring, and verification processes—bringing transparency and predictability to the regional supply architecture—and that the 6th Medical Supply Chain Management Congress provides an appropriate platform to translate this dialogue into concrete cooperation steps.

Organizing Committee of the Medical Supply Chain Management Congress