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The Turkish Pharmaceuticals and Medical Devices Authority (TİTCK) recently published the Guidance on Good Distribution Practice for Medicinal Products for Human Use and the Guidance on Risk-Based Good Clinical Practice Audits. In addition, it has amended the Medical Device Regulation and the In Vitro Diagnostic Medical Device Regulation. Moreover, the Ministry of Health (“Ministry“) recently amended the Regulation on the Cascading of Health Service Providers.
Please click on the relevant link below for our specific notes regarding the recent developments.
Guidance on Good Distribution Practice for Medicinal Products for Human Use
Guidance on Risk-Based Good Clinical Practice Audits
Amendments to the Regulation on the Cascading of Health Service Providers
Amendments to the Medical Devices Regulation
Amendments to the In Vitro Diagnostic Medical Devices Regulation
Guidance on Good Distribution Practice for Medicinal Products for Human Use
New Development
TİTCK published the Guidance on Good Distribution Practices for Medicinal Products for Human Use on 12 August 2022. The main aim of the guidance is to protect the quality and integrity of the products and to establish effective control of the distribution chain. Pharmaceutical businesses must align their activities with the provisions of the guidance within 12 months of its effective date.
The guidelines are available here (in Turkish).
What Does the Guidance Regulate?
The guidance regulates the procedures and principles regarding the purchase, sale, export, storage, distribution and shipment of medicinal products for human use, covering the entire supply chain, in accordance with good distribution practices and relevant nationally and internationally accepted standards. Parties that are required to comply with the guidance are (i) pharmaceutical businesses, (ii) manufacturers that distribute their own products, (iii) businesses operating in certain customs areas such as free zones and (iv) other stakeholders involved in the distribution of products.
To meet the quality objectives, the guidance envisages establishing an effective quality management system and appointing a quality assurance officer. It is also necessary to have a written process plan to supervise the proper functioning of this system. The guidance further underlines the importance of a proper documentation system to establish an effective quality management system. The guidance also emphasizes that it is essential to keep the records for at least five years in an easily accessible folder, especially in the case of urgent need.
In addition to this, the premises should be designed to ensure that products are kept in accordance with the storage conditions. It should be sufficiently secure and structurally sound for transporting and storing the products, and have an adequate storage and processing capacity. Equipment should be regularly maintained to be fit to serve its intended use. In addition, the packaging, labeling and special conditions of medicinal products for human use should be cautiously considered before their shipment.
Finally, complaints about the products should be carefully recorded, and the reasons for returning products should be closely examined by adopting a risk-based approach. In the case of encountering a counterfeit medicinal product for human use, the relevant authorities should be informed immediately and, if necessary, the products should be withdrawn effectively. Regular internal audits are required to monitor compliance with all these processes and to suggest necessary remedial measures.
Guidance on Risk-Based Good Clinical Practice Audits
New Development
TİTCK published the Guidance on Risk-Based Good Clinical Practice Audits on 9 August 2022. The guidance aims to define and standardize the processes for risk-based good clinical practice audits.
The guidance is available here (in Turkish).
What Does the Guidance Regulate?
The guidance lays out the general aspects of audits of good clinical practice. Audits are conducted to ensure that the clinical trial complies with the relevant regulations, to verify the reliability and accuracy of the data presented in the file, and to answer questions that may arise during the evaluation process. Audits may occur (i) before the clinical trial is conducted, (ii) during or after the clinical trial, (iii) to verify the registration application or (iv) for follow-up purposes after licensing. Good clinical practice audits can be triggered “for a reason” or conducted as part of a routine audit.
Routine Audits
Routine audits are audits conducted for the routine control of compliance with good clinical practice. The generic and original human medicinal product license application file within the scope of the audit is selected by the Department of Pharmaceutical Licensing or the Herbal and Supplementary Products Department on a risk-based basis, and the Audit Services Vice Presidency decides whether the audit is required.
“For a reason” Audits
“For a reason” audits are audits requested by the Department of Pharmaceutical Licensing or the Herbal and Supplementary Products Department in all clinical trials conducted with a medicinal product for human use or in a study conducted at a particular center during the registration application evaluation process due to a concern regarding good clinical practice. The processes regarding the audit request, decision and planning are carried out in the same way as the processes regulated in routine audits.
Amendments to the Regulation on the Cascading of Health Service Providers
New Development
TİTCK published the Regulation on the Amendments to the Regulation on the Cascading of Health Service Providers on 30 July 2022. The regulation introduced some monitoring and evaluation criteria and new rules for the cascading of hospitals operating in specific branches.
The regulation is available here (in Turkish).
What’s New?
The main amendments introduced by the regulation are as follows:
- The Turkish Stem Cell Coordination Center is included in the list of healthcare providers that are directly classified as third-grade care providers.
- Conditions and standards for the public and private sector hospitals that operate in some areas to be classified as third-grade health service providers have been introduced. Accordingly, the relevant hospitals must meet certain criteria, such as size, bed capacity, number of branches, and number of specialists and nurses.
- The annual total number of surgeries performed in hospitals providing health services in a particular specialty is at least 4,000. The number of operations in the A-B-C group should be at least 15% of the total number of operations.
- Private hospitals, which have a cooperation protocol with foundation universities prior to the date of the regulation’s entry into force, are cascaded according to the provisions of the said regulation by the expiration of their cooperation with the university.
Amendments to the Medical Devices Regulation
New Development
TİTCK published the Regulation on the Amendments to the Medical Devices Regulation on 29 July 2022. The regulation amended the general obligations and provisions on the reporting procedures of clinical trials.
The regulation is available here (in Turkish).
What’s New?
The main amendments introduced by the regulation are as follows:
- Advanced therapy medicinal products including gene therapy, somatic cell therapy and tissue engineering products are excluded from the scope of the Medical Device Regulation.
- Manufacturers are obliged to provide on medical devices, on their packaging or on accompanying documents (i) necessary information on the potential risks and (ii) instructions of use as regulated under Law No. 7223 on Product Safety and Technical Regulations.
- Disposable devices that have been placed on the market in accordance with the repealed Medical Device Regulation can be reprocessed, provided that they are supplied before 26 May 2021.
- In the reporting of serious adverse events and field safety corrective actions to TİTCK by the health professionals, the users and the patients, TİTCK will take appropriate measures, such as organizing informative events, to ensure that an adequate level of care is demonstrated during the submission of such reports.
Amendments to the In Vitro Diagnostic Medical Devices Regulation
New Development
On 29 July 2022, TİTCK amended the In Vitro Diagnostic Medical Devices Regulation. The regulation includes amendments to the general obligations, procedures for performance studies, reporting of activities and transitional provisions.
The regulation is available here (in Turkish).
What’s New?
The main amendments introduced by the regulation are as follows:
- Compliance has been achieved between the manufacturer’s obligations in Law No. 7223 on Product Safety and Technical Regulations and the general obligations of the manufacturers in the regulation.
- In the reporting of serious adverse events and field safety corrective actions to TİTCK by the health professionals, the users and the patients, TİTCK will take appropriate measures, such as organizing informative events, to ensure that an adequate level of care is demonstrated during the submission of such reports.
- Devices that have been issued by the repealed In Vitro Medical Diagnostic Devices Regulation and that have a valid certificate in accordance with the legislation may be placed on the market until 25 May 2025.
Conclusion
TİTCK and the Ministry continue to provide guidance for companies working in the healthcare industry. Companies should carefully review TİTCK’s and the Ministry’s announcements and take the necessary actions to ensure compliance.
