Calendarization Process for the Market Authorization of Medicines

Introduction

The Guidelines for the Calendarization Process of Medicinal Products for Human Use (the “Guidelines”) aims to regulate the process for the market authorization applications on medicinal products for human use filed with the Turkish Medicines and Medical Devices Agency (the “Agency”). The Agency has determined the procedures and principles for calendarization processes of the applications found eligible in the pre-assessments. The Guidelines has been initially published on the official website of the Agency in 2023 and has been updated in December 2023, February 2024 and August 2024.

Calendarization Processes

Pursuant to the Guidelines, the calendarization information of the market authorization applications found eligible in the pre-assessments, is announced with two separate lists published in the official website of the Agency in the first week of every month: “List of Active Ingredients Pending Calendarization” and “Active Ingredient List of Medicinal Products for which the Market Authorization Process has Started”.

After the examination of the Pre-Assessment Unit (CTD), the application file is then included in the “List of Active Ingredients Pending Calendarization”. The initiation of the authorization process for the products on this list will be determined by taking into account the authorization capacity of the Agency. Pursuant to Article 7 of the Guideline, the applications found eligible will then be transferred to the “Active Ingredient List of Medicinal Products for Human Use for which the Market Authorization Process has Started”

The commencement dates of the market authorization period for the products added to these lists are determined based on the Regulation on the Licensing of Medicinal Products for Human Use (the “Regulation”) According to Article 14 of the Regulation, after examining the application, the Agency will officially inform the applicant whether the application is accepted or denied. However, the date of the notification of acceptance will not be considered as the commencement date of the market authorization period the commencement of the market authorization period will be informed separately when the application is completed.

Introduction of Innovative Products to the Market

It is critical to foresee the introduction of innovative medicinal products to the market within the governance of the market authorization process for medicinal products for human use. The calendarization and listing processes provided by the Guidelines helps the applicants and shareholders understand what stage the authorization application is at and when it will be finalized. This transparency enables the firms to plan the product development and market strategies more efficiently. Moreover, providing insights to the authorization processes in a certain time frame will support innovative products to gain a foothold in a competitive environment more quickly. Thus, the systematic tracking of the market authorization processes will quicken the market launch of medicinal products and, as a result, provide faster access to healthcare systems and patients as well. 

Patent Protection and Action Plans

In addition, it is of utmost importance to manage human medicinal product market authorization processes efficiently, especially in the case where the market launch of the generic versions of patent protected products is planned. The regulation of the calendarization processes, the timing and assessment stages of the market authorization applications play a critical role in terms of legal compliance and market strategies. Careful planning of these processes offers significant benefits in terms of market timing, financial planning, and providing a competitive advantage. Thus, the action plans construed within the management of the market authorization processes, aside from providing protection of patent rights, will also contribute to the successful market presence of the products and gaining sustainable competitive advantage.