The recent developments in the healthcare sector are: (i) the Draft Guideline on the License Application for Foods for Special Medical Purposes, (ii) the Draft Guideline on the Stability Studies of Foods for Special Medical Purposes published by the Turkish Pharmaceuticals and Medical Devices Authority (“TİTCK“) and (iii) the Guideline on the Distance Health Information Systems (tr.USBS) published by the General Directorate of Health Information Systems (“General Directorate“).
Please click on the relevant link below for our specific notes regarding the recent developments:
What do the Draft Guidelines on the License Application for Foods for Special Medical Purposes and the Stability Studies of Foods for Special Medical Purposes introduce?
On 24 May 2022, the TİTCK published the Draft Guideline on the Stability Studies of Foods for Special Medical Purposes (“Draft Guideline on the Stability Studies“) and the Draft Guideline on the License Application for Foods for Special Medical Purposes (“Draft Guideline on the License Application“). The said guidelines introduce regulations regarding the stability studies and licensing processes of foods for special medical purposes (tr.ÖTAG), on which there are ongoing legislative studies. The draft guidelines are available here (in Turkish).
Stakeholders can submit their opinions via tı[email protected] until 8 June 2022.
Draft Guideline on the Stability Studies
The Draft Guideline on the Stability Studies regulates the stability studies required in the permit process. Stability studies determine the shelf life and storage conditions by presenting data on the change of ÖTAG quality over time under the influence of environmental factors such as temperature and humidity.
As per the guideline, the following must be submitted to the TİTCK covering a period of at least six months: (i) a long-term stability study performed with at least two batches and (ii) an accelerated stability study performed with one batch. In the studies, the properties of the final product whose effectiveness, safety and quality change depending on the storage conditions must be determined. The studies must be carried out in the laboratories of the manufacturer or in accredited analysis laboratories in accordance with the work plans envisaged in the guideline.
If the data obtained as a result of the study shows negligible degradation or variation, the requested shelf life will be approved without a routine statistical analysis, provided that the situation is justified. In addition, if the real time data is supported with data on accelerated conditions, the shelf life can be extended based on the real time studies.
Stakeholders can apply to the TİTCK for an opinion regarding the parameters that are to be studied and whether a new study is required after a change in the primary packaging.
Draft Guideline on the License Application
The Draft Guideline on the License Application regulates the information and documents that are required in the ÖTAG license application in accordance with the Regulation on the Licensing of Foods for Special Medical Purposes.
As per the guideline, (i) administrative information, (ii) quality-related information and (iii) clinical information of the ÖTAG are to be included in all license application files. The guideline sets forth the elements that must be covered in each section. Any kind of information including detailed information about incomplete or interrupted clinical research and/or completed research with a medical purpose that was not mentioned in the application must be submitted in the application regardless of whether it is in favor of or against the ÖTAG.
What does the Guideline on the Distance Health Information Systems introduce?
In the Guideline on the Distance Health Information Systems published on 13 May 2022, the General Directorate set forth the minimum requirements that USBSs must meet in accordance with the Regulation on the Provision of Distance Health Services, which entered into force on 10 February 2022. The guideline is available here (in Turkish).
As per the Guideline, distance health service providers are responsible for ensuring that USBSs comply with the data definitions determined by the Ministry of Health, business rules, software release notes, health informatics standards, developments and data submission services published by the General Directorate.
USBSs can be operated with or without integration with the Health Information Management Systems (tr.SBMS).
The guideline sets forth: (i) the general characteristics that must be found in USBSs, (ii) the features of USBSs that can record video and/or sound must have and (iii) the features that the USBSs can operate without integration to the SBYS must have. In this context, features such as interfaces that allow the management of the user accounts that can only be accessed by users with two-factor authentication, CAPTCHA verification in case of incorrect login attempts, recording of successful and unsuccessful authentication attempts, storing password information irreversibly, providing Turkish language support, encrypted communication over USBS, information about the relevant health personnel and informing the parties about the terms of service before the meeting should be available in all USBSs. USBS data must be stored in Turkey and USBS servers that allow instant messaging/call must be located in Turkey.
USBSs that can record video and/or sound must also have other features such as obtaining explicit consent of the parties on the recording of their video and/or sound prior to the service, prevention of unauthorized access by storing audio and/or video recordings in encrypted form and deleting the records permanently upon the legal period.
USBSs that can operate without integration with SBYS must have features such as providing a list of the clinics or physicians available for appointment, creating an appointment, enabling the physicians to issue e-prescriptions and e-reports and report their findings to USBS without connecting to another SYBS via USBS and having integration with the Central Population Management System (tr.MERNIS).
The TİTCK and General Directorate continue to provide guidance for companies working in the healthcare industry. Companies should carefully review the guidelines and take the necessary actions to ensure compliance.
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