THE REGULATION ON THE AUTHORIZATION OF ADVANCED TREATMENT MEDICINAL PRODUCTS IS PUBLISHED

The Regulation on The Authorization of Advanced Treatment Medicinal Products was published in the Official Gazette No. 32203 on May 27, 2023.

The purpose of this regulation is to determine the procedures, principles, and practices to be applied in the authorization and pharmacovigilance processes for advanced therapy medicinal products to ensure that they have the desired level of efficacy and safety and meet the required quality standards.

The advanced therapy medicinal products are defined as (i) gene therapy medicinal product, (ii) somatic cell therapy medicinal product, (iii) tissue engineering product, or (iv) any of the medicinal products for human use. It should be noted that pursuant to Article 2/b, the advanced treatment medicinal products including living cells and tissues are considered within the scope of this Regulation regardless of the role of the medical device since the pharmacological, immunological or metabolic effects of such cells and tissues are deemed as the main effect of the combination product. On the other hand, this regulation does not cover vaccines for infectious diseases.

According to Article 6 of the Regulation, any advanced therapy medicinal product that is not authorized by the Turkish Medicines and Medical Devices Agency (TITCK) according to the provisions of this regulation cannot be launched in the market.

Applications for advanced treatment medicinal products made prior to this Regulation in accordance with Communiqué No. 28962, are admitted filing their updated applications in accordance with this Regulation before the TITCK within 3 months as of the publication date of this Regulation.

Sources:

https://www.titck.gov.tr/duyuru/ilac-firmalarinin-dikkatine-29052023111157

https://www.resmigazete.gov.tr/eskiler/2023/05/20230527-7.htm