Tag: RegulatoryCompliance

21/02/2026

Appointing a Legal Representative for Clinical Trials in Turkey

Multinational clinical trials offer foreign pharmaceutical companies the opportunity to bring innovative treatments to a broader patient population. However, expanding the research footprint also brings the complex requirement of complying with diverse international regulations.

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12/01/2026

Navigating TITCK’s Latest Guidance: Which Products Are Excluded from Medical Device Regulations?

In the rapidly evolving landscape of Turkish healthcare regulations, distinguishing between a "medical device" and a "general use product" is critical for manufacturers and importers. TITCK recently published a vital announcement regarding products that do not fall within the scope of the MDR and IVDR.

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13/12/2025

What measures should be taken by Sponsors in case of missing investigation products during clinical trials in Turkiye

The loss of investigational products (IP) during a clinical trial severely influences the clinical trial’s integrity, participant safety, and regulatory compliance. When the absence of IPs is noticed during a clinical study, implementing the necessary measures by Sponsors in a timely manner is of great importance. 

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