News and Publications

The Guideline on Clinical Trial Applications to the Clinical Trials Department of the Turkish Medicines and Medical Devices Agency (“Guideline”), published by the Turkish Medicines and Medical Devices Agency, regulates in detail the Initial Eligibility Application, Amendments to Trials, […]

At the meeting of the Advertisement Board numbered 341 and held on 8 January 2024, a new principle decision regarding discount sales advertisements was made in the Guidelines on Advertisements Containing Price Information, Discount Sale Advertisements and Commercial Practices […]

Turkish Medicine and Medical Devices Agency (“Agency”) has published several announcements in December. According to the announcement published on December 15, 2023 (“Announcement 1”), The European Commission’s Directorate-General for Health and Food Safety and the European Executive Agency for […]

In accordance with the Regulation Amending the Licensing of Medicinal Products for Human Use Regulation, published in the Official Gazette dated 26.12.2023, and numbered 32411, new concepts and regulations have been introduced. The Regulation Amending the Licensing of Medicinal […]

The Regulation on the Amendment to the Regulation on Variations in Licensed Medicinal Products for Human Use by the Turkish Medicines and Medical Devices Agency (“Agency“) was published in the Official Gazette dated 26 December 2023 and numbered 32411. […]

Within the scope of the Regulation on Clinical Trials of Medicinal Products for Human Use published in the Official Gazette dated 27/05/2023 and numbered 32203, the Draft Guideline on the Definition of Investigational Products and on the Use of […]

The Guideline on the Procedures and Principles of Pharmacovigilance Activities Conducted by Contracted Pharmacovigilance Service Organizations and Marketing Authorization Holders (“Guideline“) prepared by the Turkish Medicines and Medical Devices Agency will enter into force as of 01.01.2024, except for […]

The grant agreement (“Grant Agreement“) concluded between the Republic of Türkiye and the International Bank for Reconstruction and Development and the International Development Association (“Bank“), published in the Official Gazette dated 12 December 2023 and numbered 32397, stipulates the […]

The Regulation Amending the Regulation on Principles and Rules to be Applied in Retail Trade (“Amending Regulation“) was published in the Official Gazette dated 14.12.2023 and numbered 32399. Accordingly, the Amending Regulation defines the concept of “agricultural and food […]

The Decision on Türkiye Sustainability Reporting Standards issued by the Public Oversight, Accounting and Auditing Standards Authority by considering the standards of the International Sustainability Standards Board was published in the Official Gazette. The decision regulates the scope of […]