Comprehensive Overview Of Turkish Healthcare Legislation

Introduction

As we progress through 2024, the Turkish healthcare sector continues to evolve rapidly, with numerous legislative changes affecting various aspects of the industry. At Lexin Legal, we understand the importance of staying informed about these developments. This comprehensive blog post aims to provide a detailed analysis of the recent changes in healthcare legislation, covering medicinal products, medical devices, and cosmetics.

1. Medicinal Products for Human Use

A. Clinical Trial Regulations

The Turkish Medicines and Medical Devices Agency (TMMDA) has introduced several significant amendments to guidelines governing clinical trials:

Amendment to the Guideline on Clinical Trial Applications:

• Investigational product application files are now mandatory for initial applications.
• A benefit-risk assessment plan or report is required, explaining why expected benefits outweigh risks.
• Applications must be submitted electronically, with physical documents only required upon specific request.
• The trial initiation period has been clarified as two years from authorization delivery.

Amendment to the Guideline on Clinical Trial Applications to Ethics Committees:

• The notification period for clinical trial completion has been reduced from 90 to 15 days.
• If the trial is completed in all countries, the notification period is 30 days.
• The benefit-risk assessment report must now be included in the Ethics Committee application file.

New Guideline on Labelling of Investigational Products and Ancillary Medicinal Products:

• This guideline outlines rules for information on outer and inner packaging and labels.
• It aims to ensure traceability through an effective quality system.

B. Manufacturing and Quality Control

Amendment to the GMP Guideline on Manufacturing Facilities:

• Updated to align with the latest Pharmaceutical Inspection Cooperation Scheme guidelines.
• Elaborates on regulations in Annexes 1, 13, and 16, covering sterile medicinal products, investigational medicinal products, and certification by responsible managers.

Amendment to the Guideline on Non-Clinical Evaluation of Animal Immunoglobulins:

• Removes the "abnormal toxicity test" requirement for finished products.
• Aligns with current European Pharmacopoeia standards.

C. Market Access and Promotion

Amendment to the Guideline on the Procurement of Medicinal Products from Abroad:

• Introduces new assessment criteria for foreign drug applications.
• Allows procurement of medicines containing relevant active substances when licensed products are unavailable in the market.

Draft Regulation on Promotional Activities:

• Expands scope to include foods for special medical purposes.
• Open for stakeholder feedback until June 10, 2024.

D. Market Analysis

The TMMDA published a comprehensive Pharmaceutical Market Observation Report, highlighting:

• The Turkish pharmaceutical market grew 5.5 times from 2016 to 2022.
• 57.5% of top-selling biotechnological products were diabetes treatments.

Medical Devices

A. Regulatory Framework

Communiqué on Common Specifications for Product Groups Without Intended Medical Purpose:

• Replaces previous guideline, aligning more closely with EU legislation.

Transitional Provisions for Medical Devices:

• Devices manufactured under the old EU Medical Devices Directive (MDD) cannot be placed on the market after May 26, 2024, unless they meet specific criteria.
• Devices already on the market can remain for their shelf life.

Product Tracking System (ÜTS) Updates:

• New rules for products ineligible for time extension.
• Prohibits forward single product movement notifications for non-compliant devices after May 26, 2024.

B. Sector Review

The TMMDA conducted a comprehensive review of the medical device sector:

• Highlighted the positive impact of CE certification on imports and exports.
• Analyzed healthcare expenditure trends from 2012 to 2022.
• Projected market values for different device categories through 2026.
• Discussed investment incentives and R&D expenditures in the sector.
• Provided statistics on ÜTS registrations and clinical trial applications.

C. In Vitro Diagnostic Medical Devices

A draft communiqué on common specifications for certain Class D in vitro diagnostic medical devices has been released for stakeholder feedback.

Cosmetics

A. Safety Assessor Training and Certification

1. New Guideline on Cosmetic Product Safety Assessor Training and Certification:
   • Outlines profession requirements for obtaining safety assessor certificates.
   • Specifies training programs, exam processes, and certificate validity periods.
   • Amended on May 6, 2024, to include more details on training and certification processes.

B. Regulatory Updates

The Cosmetic Products Regulation is being revised to align with recent EU regulations:

• Focuses on restrictions for substances like Vitamin A, Alpha-Arbutin, and potential endocrine disruptors.
• New concentration limits expected for certain substances in cosmetic products.

Conclusion

These legislative changes demonstrate Turkey's commitment to aligning its healthcare regulations with EU standards and enhancing the quality and safety of healthcare products. For businesses operating in the Turkish healthcare sector, understanding and adapting to these changes is crucial for maintaining compliance and competitiveness.

At Lexin Legal, our team of specialized healthcare lawyers is dedicated to helping you navigate this complex regulatory landscape. We offer tailored legal advice on how these new regulations may impact your business and can assist in developing comprehensive compliance strategies.

Key Takeaways:

1. Clinical trial regulations have been updated to enhance safety and efficiency.
2. Manufacturing guidelines now align more closely with international standards.
3. Medical device regulations are undergoing significant changes, particularly regarding market access.
4. The cosmetics industry faces new requirements for safety assessors and potential restrictions on certain ingredients.

We encourage all stakeholders in the Turkish healthcare sector to review these changes carefully and seek professional legal advice to ensure full compliance. Our team at Lexin Legal is always available to provide detailed guidance and support.

Stay tuned for further updates as we continue to monitor developments in Turkish healthcare legislation. For more information or to schedule a consultation, please contact our healthcare law specialists.

FAQ

1. Q: What are the major changes to clinical trial regulations in Turkey?
   A: Key changes include mandatory submission of investigational product files, requirement of benefit-risk assessment plans, reduced notification periods for trial completion, and electronic submission of applications.
2. Q: How has the labeling process for investigational products changed?
   A: A new guideline has been introduced outlining rules for information on outer and inner packaging and labels to ensure better traceability.
3. Q: What updates have been made to manufacturing guidelines?
   A: The GMP Guideline has been updated to align with the latest Pharmaceutical Inspection Cooperation Scheme guidelines, particularly elaborating on regulations for sterile medicinal products, investigational medicinal products, and certification processes.
4. Q: Are there any changes to the procurement of medicinal products from abroad?
   A: Yes, new assessment criteria have been introduced for foreign drug applications, and procurement of medicines with relevant active substances is now allowed when licensed products are unavailable in the market.
5. Q: What's new in the medical device sector?
   A: Significant changes include new common specifications for products without intended medical purpose, updated transitional provisions for devices certified under the old EU Medical Devices Directive, and new Product Tracking System (ÜTS) processes.
6. Q: When will medical devices manufactured under the old EU Medical Devices Directive (MDD) be phased out?
   A: These devices cannot be placed on the market after May 26, 2024, unless they meet specific criteria. However, devices already on the market can remain for their shelf life.
7. Q: What changes have been made to cosmetics regulations?
   A: A new guideline on Cosmetic Product Safety Assessor Training and Certification has been introduced, and the Cosmetic Products Regulation is being revised to align with recent EU regulations, particularly concerning restrictions on certain substances.
8. Q: How has the Turkish pharmaceutical market changed in recent years?
   A: According to the recent TMMDA report, the Turkish pharmaceutical market grew 5.5 times from 2016 to 2022.
9. Q: Are there any new regulations for promotional activities of medicinal products?
   A: Yes, a draft regulation has been released that expands the scope to include foods for special medical purposes. It's currently open for stakeholder feedback.
10. Q: What should businesses in the Turkish healthcare sector do in light of these changes?
    A: Businesses should carefully review these changes, assess their impact on operations, and seek professional legal advice to ensure full compliance with the new regulations.
11. Q: Where can I find more information about these legislative changes?
    A: For more detailed information and personalized legal advice, you can contact Lexin Legal's healthcare law specialists.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.