Menu

    Insights Life Sciences & Healthcare

    Healthcare & Life Sciences Newsletter

    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.

    Sağlık & Yaşam Bilimleri Bülteni

    Türkiye İlaç ve Tıbbi Cihaz Kurumu (“Kurum”) geçtiğimiz haftalarda, Türkiye İlaç ve Tıbbî Cihaz Kurumu Ulusal Kontrol Laboratuvarının Görev, Yetki ve Sorumlulukları ile Çalışma Usul ve Esasları Hakkında Yönetmelik, Farmakovijilans Sistemi Kılavuzu, (AB) 2022/2346 Sayılı ve (AB) 2022/2347 Sayılı Uygulama Tüzükleri hakkında duyuru ve Tıbbi Cihaz Klinik Araştırmaları Hakkında duyuru yayımladı. Kurum ayrıca (i) Beşeri Tıbbi Ürünlerin Fiyatlandırılmasına Dair Karar, (ii) Beşeri Tıbbi Ürünler Ruhsatlandırma Yönetmeliği, (iii) Ayakta Teşhis ve Tedavi Yapılan Özel Sağlık Kuruluşları Hakkında Yönetmelik, (iv) Özel Hastaneler Yönetmeliği, (v) Diagnostik Radyoloji, Nükleer Tıp ve Radyoterapi Grubu Tıbbi Cihazların Kalite Uygunluk ve Kalite Kontrol Testleri Hakkında Yönetmelik Hükümlerinin Uygulanmasına İlişkin Kılavuz, (vi) Yurt Dışı Üretim Tesislerinin GMP Denetimleri İçin Yapılacak Müracaatlara Dair Kılavuz ve (vii) Beşeri Tıbbi Ürünlerin Fiyatlandırılması Hakkında Tebliğ’de değişiklik yaptı. Son olarak Kurum Endikasyon Dışı/Yurt Dışı İlaç Kullanımına İlişkin Onay Sürelerinin Uzatılması Hakkında Kararının iptaline karar verdi.

    The Euro Value Applied to Pharmaceutical Prices was increased by 36.77%

    On 14 December 2022, the presidential decree numbered 6546 (“Decree”) amending the Decision on Pricing of Medicinal Products for Human Use was published in the Official Gazette numbered 32043.

    Life Sciences 2023 in Turkey

    The healthcare system is governed principally by the Fundamental Law on Healthcare Services No. 3,359 and dated 15 May 1987, which furnishes the Ministry of Health (MoH) with the authority to issue healthcare-related regulations and establish a healthcare system enabling each and every person living in Turkey to have equal and equitable access to the healthcare system. The regulatory authority is the MoH and its subsidiaries.

    Guidelines on Donation of Non-Approved Drugs

    On 28 September 2022, the Turkish Medicines and Medical Devices Agency (Agency) published guidelines (Turkish language) on donation from abroad of human medicinal products that are not approved in Turkey on its official website.

    New Provision Introduced to Decision on Drug Pricing

    On 9 November 2022, the Presidential Decree numbered 6365 Amending the Decree on Pricing of Medicinal Products for Human Use (Turkish language) (Decision) was published in the Official Gazette numbered 32008.