Navigating the Turkish Market: Pharmacovigilance and Regulatory Services

This blog post dives into pharmacovigilance and regulatory services in Turkey, guiding you through the key aspects.

The Watchful Eye: Pharmacovigilance in Turkey

Pharmacovigilance, the science of monitoring drug safety, is crucial in Turkey. The Turkish Pharmacovigilance Centre (TUFAM) acts as the national authority, overseeing adverse drug reaction (ADR) reporting.

Here's a breakdown of the reporting system:

• Mandatory Reporting: All healthcare professionals (HCPs) must report serious and suspected ADRs to TUFAM.
• Optional Reporting: HCPs can submit spontaneous reports directly to TUFAM or through the marketing authorization holder (MAH).
• Marketing Authorization Holder Responsibility: MAHs are required to have a Qualified Person for Pharmacovigilance (QPPV) who supervises pharmacovigilance activities.

Challenges and Considerations

While Turkey has adopted WHO-standard pharmacovigilance solutions, there are challenges:

• Underreporting: Public awareness and reporting habits among healthcare professionals can be limited.
• Language Barrier: Reporting forms might be inaccessible for non-Turkish speakers.

Ensuring Compliance: Regulatory Services

To navigate the Turkish market smoothly, consider partnering with a company offering regulatory services. These companies can assist with:

• Dossier Preparation and Submission: Meeting the specific requirements of the Turkish Medicines and Medical Devices Agency (TMMDA) for dossier compilation and submission can be complex. Regulatory service providers can ensure your dossiers are compliant.
• Regulatory Strategy: Developing a risk-free approach to gain marketing authorization for your products requires expertise in Turkish regulations.
• Compliance Management: Staying updated on regulatory changes and ensuring ongoing compliance is essential. Regulatory service providers can help you navigate this.

The Takeaway

The Turkish pharmaceutical market offers significant potential. By understanding pharmacovigilance requirements and partnering with regulatory service providers, you can ensure your products enter the market safely and compliantly.