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Biologics Compliance Guide for Turkey

This is a compliance guide for clinics that want to operate in Turkey.

Key Pieces of Legislation:

1. Regulation on the Marketing Authorization of Medicinal Products for Human Use

This regulation sets forth the norms and principles for granting marketing authorization for medicinal products, including biologics.


2. New Regulation on the Licensing of Medicinal Products for Human Use

This document provides detailed guidelines for the licensing of medicinal products, aiming to harmonize with EU directives and streamline the licensing process.


3. Turkey Issues New Detailed Biosimilar Guidance

This guidance provides detailed information for companies looking to bring biosimilar products to market in Turkey, including requirements for product development and documentation.


4. Understanding Biologics and Biosimilars in Turkey

This article provides an overview of the regulatory landscape for biologics and biosimilars in Turkey.


5. Compliance Checklist

Compliance with Turkish Ministry of Health Regulations:

  • Ensure adherence to the guidelines and regulations set by the Turkish Ministry of Health for stem cell therapies.

Approval from Regulatory Bodies:

  • Obtain necessary approvals from relevant regulatory bodies for the use of stem cell therapies.

Ethical Approval:

  • Obtain necessary approvals from relevant regulatory bodies for the use of stem cell therapies.

Informed Consent:

  • Obtain informed consent from patients, clearly explaining the potential risks, benefits, and alternatives to the treatment.

Proper Handling and Storage:

  • Follow proper protocols for the handling, storage, and administration of stem cells to maintain their viability and safety.
  • Documentation and Record-Keeping:

Post-Treatment Monitoring:

  • Establish a system for monitoring and documenting patient outcomes post-treatment.
  • Be prepared to report any adverse effects or complications to the appropriate regulatory bodies.

Public Awareness and Patient Education:

  • Provide patients with clear information regarding the experimental nature of stem cell treatments.
  • Educate patients about potential risks, benefits, and the current state of research.

Insurance and Financial Considerations:

  • Ensure transparency regarding the costs associated with stem cell treatments.
  • Verify coverage and reimbursement options for patients through health insurance providers.

Continuous Education and Training:

  • Stay updated on the latest research, regulations, and best practices in stem cell therapy.
  • Participate in training programs and conferences related to regenerative medicine.


6. Who can administer
  • Doctors (General Practitioners and Specialists): Physicians with appropriate licenses who are trained in regenerative medicine and stem cell therapies.
  • Nurses: Registered nurses who are certified and licensed to assist in the administration of stem cell treatments under the supervision of a licensed physician.
  • Pharmacists: Licensed pharmacists who can dispense stem cell products in accordance with regulatory guidelines.
  • Medical Assistants: Certified medical assistants who work under the supervision of licensed healthcare professionals.