Is it really necessary to work with a consultant for entering Turkish market?

The Turkish pharmaceutical market is one of the most dynamic in the world, serving as a strategic bridge between Europe and Asia. However, for foreign companies, the entry process is famously complex. The regulatory landscape is governed by the Turkish Medicines and Medical Devices Agency (TİTCK), and navigating its requirements—from GMP inspections to local pricing decrees—requires more than just a good product; it requires local expertise.

Here is why partnering with a specialized pharma consulting firm is no longer an “option” but a necessity before starting the registration process in Türkiye.

1. Navigating the Mandatory Local Representation

Turkish law is clear: any pharmaceutical product imported into the country must be registered by a legal entity based in Türkiye. Foreign manufacturers cannot hold a marketing authorization (MA) directly from abroad.

Pharma consultants assist in:

• Establishing a Local Branch: Guiding you through the legal incorporation of a Turkish subsidiary.

• Finding a Reliable Local License Holder: If you don’t wish to open an office, consultants help you partner with a trusted local company to hold the license on your behalf while you retain ownership of the brand.

2. Managing the GMP Inspection Queue

Perhaps the biggest “bottleneck” in the Turkish registration process is the Good Manufacturing Practice (GMP) certification. Unlike many other nations, Türkiye does not always automatically accept EU or FDA GMP certificates; TİTCK often insists on conducting its own physical inspections of foreign manufacturing sites.

Consultants are vital here because they:

• Audit Readiness: Perform “mock audits” to ensure your facility meets TİTCK’s specific standards before the Turkish inspectors arrive.

• Timeline Strategy: Help navigate the long waiting lists for inspections, ensuring your application is prioritized and documentation is flawless to avoid a “re-start” of the clock.

3. The Complexity of Pricing and Reimbursement

Even if your medicine is medically approved, it cannot be sold effectively without a price and, often, inclusion in the reimbursement list.

Türkiye uses a Reference Pricing System, where the price is linked to the lowest prices in a pool of EU countries (usually France, Spain, Italy, Portugal, and Greece). Furthermore, the government sets a fixed Euro-to-Lira exchange rate for medicines, which is significantly lower than the market rate.

Consultants provide:

• Economic Analysis: Calculating the “lowest price” impact on your global margins.

• Negotiation Support: Representing your interests during Social Security Institution (SGK) reimbursement negotiations, where “alternative reimbursement models” are often the only way to launch innovative drugs.

4. Dossier Adaptation (eCTD Format)

While Türkiye follows the Common Technical Document (CTD) format, the submission must be in Turkish. A simple translation is not enough; the medical and regulatory terminology must be precise to pass the preliminary “administrative check” by TİTCK.

5. Staying Ahead of Regulatory Shifts

The Turkish regulatory environment is highly reactive. For instance, in 2026, new regulations regarding the base Euro exchange rate and price protection thresholds (now set at 25.3346 TRY/EUR) have already shifted the financial landscape.

A consulting firm acts as your regulatory intelligence unit, alerting you to:

• Changes in the “Priority” list (which can shorten approval from 800+ days to 200 days).

• New requirements for biosimilars or “Named Patient Programs” (early access).

• Updates to the Product Tracking System (ÜTS) for medical device-medicine combinations.

Conclusion

Starting a registration process in Türkiye without local consultancy is like navigating a maze in the dark. From the moment you decide to enter the market, a consultant ensures that your GMP status, Pricing strategy, and Legal representation are aligned. This foresight prevents costly delays that can otherwise span years.