The Turkish Pharmaceuticals and Medical Devices Authority ("TİTCK") recently published the Regulation on the Duties, Authorities and Responsibilities of the National Control Laboratory of the Turkish Pharmaceuticals and Medical Devices Authority, Guideline on the Pharmacovigilance System, an announcement regarding European Union (EU) Implementing Regulations No. 2022/2346 and No. 2022/2347 and an announcement on Medical Device Clinical Trials. Moreover, the TİTCK has amended (i) the Decree on the Pricing of Medicinal Products for Human Use (ii) Regulation on the Marketing Authorization of Medicinal Products for Human Use; (iii) Regulation on Private Health Institutions for Outpatient Diagnosis and Treatment; (iv) Regulation on Private Hospitals; (v) Guideline on the Implementation of the Regulation on Quality Conformity and Quality Control Tests of Diagnostic Radiology, Nuclear Medicine and Radiotherapy Group Medical Devices; (vi) Guideline on Applications for Good Manufacturing Practices (GMP) Inspection of Overseas Production Facilities; and (vii) Communiqué on Pricing of Medicinal Products for Human Use. Lastly, the TİTCK announced the annulment of the Decision on the Extension of the Approval Periods for the Use of Off-Indication/ International Medicinal Products.
Regulation on the Duties, Authorities and Responsibilities of the National Control Laboratory of the Turkish Pharmaceuticals and Medical Devices Authority
The Regulation on the Duties, Authorities and Responsibilities of the National Control Laboratory of the Turkish Pharmaceuticals and Medical Devices Authority was published by the TİTCK on 30 November 2022 and entered into force through its publication. In this regard, the Regulation sets out the duties, authorities and responsibilities and working procedures and principles of the National Control Laboratory, where the analysis activities of the substances and products falling under the duties and responsibilities of the TİTCK and the serial release activities regarding the vaccines and immune serums filled and/or produced in Türkiye are carried out.
According to the said Regulation, it should be ensured that the laboratories have appropriate equipment related to the relevant fields of activity, necessary measures should be taken to ensure that the equipment used and the results of the analysis are not affected by environmental conditions. In addition, the environment should be protected from adverse conditions such as dust, humidity, steam, vibration, electromagnetic factors and harmful creatures. In addition, appropriate measures such as an emergency body and eye shower should be taken in easily accessible suitable places to be used in case of danger in the laboratory.
The Regulation is available here (in Turkish).
Guideline on the Pharmacovigilance System
The TİTCK published the Guideline on Pharmacovigilance System on 30 November 2022. The Guideline is prepared to explain the structure of the pharmacovigilance system established within the TİTCK. In this regard, the Guideline provides guidance on many issues such as the pharmacovigilance system of the TİTCK, data and records management, the duties of the TİTCK related to pharmacovigilance and the distribution of duties by units, and the duties of the Turkish Pharmacovigilance Center (TÜFAM).
The Guideline provides information on the mission and organizational structure of the TİTCK and discusses in detail the core values and functioning of the pharmacovigilance system.
The pharmacovigilance-related duties of the TİTCK are carried out by the Department of Pharmacovigilance and Controlled Substances in line with the Regulation on the Safety of Pharmaceuticals and the current Circular on Unintended Effects After Vaccination (ASIE) of the General Directorate of Public Health and Circular No. 2022/2 dated 28 September 2022. The relevant Department consists of two sub-departments, namely the TÜFAM, where pharmacovigilance activities are carried out, and Pharmacovigilance Risk Management Unit. While the TÜFAM carries out studies on adverse events, the Pharmacovigilance Risk Management Unit is more focused on the drug safety of foreign pharmaceutical authorities. According to the Guideline, the duties and responsibilities of both departments are set out in detail.
The Guideline is available here (in Turkish).
Decree on the Pricing of Medicinal Products for Human Use
On 14 December 2022, the Presidency published the Decree Amending the Decree on the Pricing of Medicinal Products for Human Use. The main amendments introduced by the Decree are as follows:
- The effective date of the actual source price or sales price changes made in accordance with the Communiqué on the Pricing of Medicinal Products for Human Use was set as the publication date of the Decree for 2022, i.e. 14 December 2022
- The value of one Euro in TRY to be used in the pricing of medicinal products for human use was increased by 36.77%, effective from 15 December 2022. The calculated increase will continue to be applied for the next year and a new Euro value will not be announced during 2023.
- The thresholds in the Decree have been updated in line with the change in the value of the Euro. They have been increased to TRY 37.10 for price-protected products and TRY 19.39 for other products. This update is effective as of 15 December 2022.
The Decree is available here (in Turkish)
Regulation on the Marketing Authorization of Medicinal Products for Human Use
On 14 December 2022, the TİTCK published the Regulation Amending the Regulation on the Marketing Authorization of Medicinal Products for Human Use, which became effective retrospectively, as of 11 December 2022. The main amendments introduced by the Regulation are as follows:
- If any of the nonconformities listed in the Regulation occur, the TİTCK should make an assessment including the safety of the nonconformity before suspending the marketing authorization. The marketing authorization may be suspended according to the results of this assessment.
- The deadline for the completion of the marketing authorization process for (i) radionuclide generators, kits, radionuclide precursor radiopharmaceuticals, industrially prepared radiopharmaceuticals placed on the market with a registration certificate and for which a marketing authorization application has been submitted; and for (ii) blood products and immunological medicinal products for human use placed on the market with an import permit and for which a marketing authorization application has been submitted, has been postponed to 31 December 2023.
The Regulation is available here (in Turkish).
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