The Regulation on Authorization of Advanced Therapy Medicinal Products has been published in Türkiye

The Regulation on Authorization of Advanced Therapy Medicinal Products (the 'Regulation') was published in the Official Gazette numbered 32203 and dated 27 May 2023.

According to the Regulation:

• The Regulation aims to establish the principles and procedures to be applied in the authorization and pharmacovigilance processes to ensure that advanced therapy medicinal products have the desired efficacy, safety, and required quality, and to determine the practices related to authorized advanced therapy medicinal products.
• The Regulation covers advanced therapy medicinal products that are prepared industrially or involve an industrial process, as well as natural and legal persons who apply for or have been granted authorization for such products.
• Tissue engineering products may include human or animal-sourced cells or tissues. The cells or tissues can be living or non-living.
• In the case of a product containing living cells or tissues, the pharmacological, immunological, or metabolic effects of these cells or tissues will be considered as the product's primary mode of action.
• An advanced therapy medicinal product containing both autologous and allogeneic cells or tissues will be evaluated for allogeneic use.
• A product that falls under the definition of somatic cell therapy medicinal product and tissue engineering product will be considered a tissue engineering product.
• A product that falls under the definition of both somatic cell therapy medicinal product and gene therapy medicinal product will be evaluated as a gene therapy medicinal product. No advanced therapy medicinal product that is not authorized by the Turkish Medicines and Medical Devices Agency (the 'Agency') according to the provisions of this Regulation can be placed on the market.
• The Agency may provide scientific advice to the applicant before or during the authorization process, subject to a fee specified in the price list, upon application.
• Authorization applications can be submitted by applicants throughout the year.
• During the preliminary evaluation, the Agency will review the authorization application according to the authorization criteria and formally notify the applicant of its acceptance or rejection.
• The advanced therapy medicinal product for which the authorization application is submitted will be subject to analysis.
• The evaluation for the renewal of the authorization will be conducted by the Agency, taking into account the benefit-risk balance, five years after the date of issuance of the authorization.
• The Regulation entered into force on 27 May 2023, which is the date of its publication.

You can access the full text of the mentioned Regulation (in Turkish) from here.

Kind regards,

Zumbul Attorneys-at-Law

info@zumbul.av.tr