Recent Developments in the Healthcare Sector

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The Turkish Pharmaceuticals and Medical Devices Authority (“ TİTCK “) recently published the results of its cosmetics sector market surveillance and inspection in Q2 of 2022 and the Medical Device Clinical Trials Regulation, and it has amended the Regulation on Clinical Trials of Drugs and Biological Products and the Regulation on the Safety of Medicines.

Please click on the relevant link below for our specific notes regarding recent developments:

Cosmetic and Biocidal Products’ Safety: Turkey Continues to Crack Down on Unsafe and Non-Compliant Products
Amendments on the Regulation on Clinical Trials of Drugs and Biological Products
TİTCK Published the Medical Device Clinical Trials Regulation
Amendments to the Regulation on the Safety of Medicines

Cosmetic and Biocidal Products’ Safety: Turkey Continues to Crack Down on Unsafe and Non-Compliant Products

New Development

TİTCK recently announced the results of its cosmetics sector market surveillance and inspection conducted in April, May and June 2022.

Of the 282 cosmetic products inspected by the TİTCK’s Cosmetics Supervision Department, 200 were noncompliant and five were unsafe. A total fine of TRY 295,000 (approximately USD 17,092) was levied against the responsible companies.

Of the 17 type 1 and type 19 biocidal products inspected by the TİTCK’s Cosmetics Supervision Department, two were noncompliant and five were unlicensed. A total fine of TRY 214,480 (approximately USD 12,426) was levied against the responsible companies.

What Do the Results Say?

The cosmetic products’ safety results reveal that there has been a significant decrease in the number of inspected products but an increase in the number of noncompliant products. On the other hand, the total amount of administrative fines has decreased compared to the results of the first quarter of 2022.

The type 1 and type 19 biocidal products’ safety results reveal that there has been a decrease in the number of inspected, unlicensed and noncompliant products. Accordingly, there is also a significant decrease in the total amount of administrative fines.

The cosmetic products’ Q2 2022 results are available here (in Turkish).
The type 1 and type 19 biocidal products’ Q2 2022 results are available here (in Turkish).

Amendments on the Regulation on Clinical Trials of Drugs and Biological Products

New Development

TİTCK published the Regulation on the Amendment of the Regulation on Clinical Trials of Drugs and Biological Products on 6 July 2022. The regulation sets forth new definitions and general principles, and new application requirements for clinical trials. It also introduces exceptional clinical trials and amendments in sanctions, inspections and various procedures and principles.

The regulation is available here (in Turkish).

What’s New?

The main amendments introduced by the regulation are as follows:

General

• The Regulation introduces definitions of the terms of activity permit, monitoring, coordinator center and healthcare professionals. It is envisaged that TİTCK will grant permission for the centers where the clinical and/or bioanalytical parts of Phase 1 clinical trials and bioavailability/bioequivalence studies are conducted.
• TİTCK can issue an activity permit provided that the relevant regulatory requirements are met during the inspections and evaluations of TİTCK in the centers where clinical trials will be carried out.

Clinical Trials

• Clinical trial applications will be submitted to the ethics committee or TİTCK by the contracted research institution residing in Turkey to be assigned by the sponsor. Sponsors who do not have a representative residing in Turkey must submit their applications through a contracted research institution residing in Turkey.
• The application will be submitted electronically together with the cover letter samples, application form and other forms published on TİTCK’s website, within the framework of the Good Clinical Practices Guideline and the other relevant guidelines of TİTCK.
• If the application is complete, the ethics committee will review the application within 12 business days and TİTCK within 22 business days. In the cases specified in the regulation, this period may be extended by 30 working days. For exceptional case studies, these periods are seven days.
• Volunteers or their legal representatives to participate in the clinical trial can be informed in advance by a physician or dentist from the research team assigned by the principal investigator.
• TİTCK will not allow the implementation of changes without ethics committee approval for changes that require approval and permission in clinical trials.
• The ethics committee and TİTCK must be notified within 15 days from the date of the start of the study, the first volunteer visit and the end date of the volunteer recruitment. In addition, within one year after the end of the trial in all centers, the summary of the clinical trial result report and a version of this summary for the volunteers’ understanding must be reported to the ethics committee and TİTCK.
• The minimum period for keeping samples of each batch of products manufactured or imported for trial, related information and documents and records related to the trial has been increased from five years to 14 years.

Sanctions and Inspections

• Within the scope of the additional measures article added to the regulation, TİTCK can take additional measures for the protection of the vulnerable, if necessary.
• In cases where the safety or health of the volunteers are at risk and the application and notification requirements are not fulfilled, TİTCK can cancel the clinical trial permit and terminate, stop the clinical trial or request a change.

The sponsor, contracted research institution and research team bear all legal and financial responsibilities of the clinical trial.

TİTCK Published the Medical Device Clinical Trials Regulation

New Development

On 8 July 2022, the TİTCK published the Medical Device Clinical Trials Regulation which regulates the procedures and principles regarding post-marketing studies and medical device clinical trials and the protection of the rights of the volunteers participating in these trials.

The regulation is available here (in Turkish).

What’s New?

• In addition to the regulations in the Medical Device Regulation, Medical Device Clinical Trials Regulation will be applied in relation to clinical trials. In this context, the research device should be investigated primarily in a non-human experimental environment or on a sufficient number of experimental animals; scientific data obtained as a result of the aforementioned experiments should provide sufficient evidence to achieve the intended goal and should not damage the genetic structure of the germ cells of the volunteer.
• Although no incentives or financial offers can be used to encourage the participation of the volunteers in the research, the expenses to be incurred by participating in the research and the loss of income arising from the working days of volunteers can be covered by the specified research budget.
• It is obligatory to insure the volunteers in all medical device clinical researches, except for studies that the ethical committee deems appropriate based on the benefit-risk ratio in medical device clinical trials carried out in line with the intended use by the manufacturer of the medical device bearing the CE mark.
• Clinical trials on vulnerable populations can be conducted within the scope of the regulations regarding permission, approval and information set forth under the Medical Device Regulation.

Until the EUDAMED functionality date, the relevant articles of the Medical Device Regulation will be applied on post-market studies and clinical trial applications. Reports regarding the termination, temporary suspension, early termination or adverse events of the clinical trial will also be carried out in accordance with the Medical Device Regulation.

• For significant changes to the safety, health or rights of the volunteers, or to the consistency or reliability of the clinical data obtained from the trial, the sponsor of the clinical trial must obtain permission of the TİTCK upon an application to be submitted including the explanations and reasons regarding the desired changes.
• To bring clinical trial devices that do not carry the CE mark to Turkey for use in the relevant trial, the sponsor must obtain permission of the TİTCK.
• The sponsor may transfer some of its duties to a contracted research institution that operates in accordance with scientific principles and good clinical practices based on a written contract. Such transfer shall not remove the legal and criminal liability of the sponsor.
• TİTCK can conduct inspections on the research carried out in Turkey or abroad, researchers and places where research is carried out either with or without prior notification. In case of incompliance, the provisions of the Turkish Penal Code and other relevant legislation will be applied.

Amendments to the Regulation on the Safety of Medicines

New development

TİTCK published the Regulation on the Amendment of the Regulation on the Safety of Medicines on 21 July 2022. The regulation introduced amendments to the definition of medicine (medical product for human use), the risk management plan and provisions regarding the notification requirement of the Marketing Authorization Holders (MAH), as well as administrative sanctions.

The regulation is available here (in Turkish).

What’s New?

The main amendments introduced by the regulation are as follows:

• The term “medicine” (medicinal product for human use) has been clearly defined to cover a substance or combination of substances used for medical diagnostic purposes.
• MAH must also include serial numbers of biological and biotechnological products in their adverse reaction reports.
• If the risk management plan is updated, the updated plan must be archived by the MAH with a separate version number and date, and it will be immediately submitted to the TİTCK if the updates require additional pharmacovigilance, risk minimization activity or changes in existing activities.
• The MAH must prepare the benefit/risk assessment reports in accordance with the European Union reference date and presentation frequency list upon obtaining the license in Turkey. If the active substance of the drug is not included in this list, benefit/risk assessment reports will be submitted to the TİTCK at the frequency stipulated under the regulation. The MAH is required to submit periodic benefit/risk assessment reports to the TİTCK in line with the Regulation on Marketing Authorization of Medicinal Products for Human Use during the extension of the license validity period of the medicine.
• Activities of the contracted pharmacovigilance service institutions that do not ensure compliance within the period granted by the TİTCK can be restricted or the permit thereof can be suspended or canceled, depending on the nature of the violation. Subject to the nature of the violation, the MAH’s drug tracking system notifications can be halted, product movements can be ceased or the marketing authorization can be suspended or cancelled.

Conclusion

The TİTCK continues to provide guidance for companies working in the healthcare industry. Companies should carefully review the TİTCK’s announcements and take necessary actions to ensure compliance