Saturday, June 15, 2024

Human Medicinal Products: Updated CTD Guide and Guidelines for Applicants by TİTCK in Turkiye

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The Turkish Medicines and Medical Devices Agency (TİTCK) has updated the “Notice to Applicants” annex of the “CTD Guide,” which outlines the procedures and principles for submitting marketing authorization applications for human medicinal products in the CTD (Common Technical Document) format, following the “Regulation on the Licensing of Human Medicinal Products” published on December 11, 2021, with the number 31686. This update is designed to guide applicants.

The updated CTD guide details how to prepare and submit marketing authorization applications in the CTD format. Volume 2B, which includes revised ICH CTD guidelines concerning Quality, Safety, and Efficacy, is provided for applicants. This guide has been prepared in line with relevant guidelines.

The CTD format applies to all application types, including new human medicinal products such as chemical entities, radiopharmaceuticals, vaccines, and herbal products. The CTD aims to facilitate regulatory reviews and communication while saving time and resources. Applicants should follow the general structure of the Common Technical Document as specified, ensuring the best possible presentation of technical information.

Reformatting Human Medicinal Products Dossiers and CTD Module Organization

Reformatting the dossiers of previously licensed human medicinal products into the new CTD format is not mandatory. However, it is recommended that firms reformat the Quality sections of the documentation voluntarily to facilitate the handling of variations and new product forms, particularly for changes after July 1, 2007.

The CTD is organized into five modules: Administrative and National Information, Summaries of Quality, Nonclinical Studies, Clinical Studies, and Additional Information. Module 1 contains administrative and national data, Module 2 includes high-level summaries, Module 3 provides chemical and biological documentation, Module 4 consists of nonclinical study reports and Module 5 includes clinical study reports. Applicants should prepare and submit their applications in this format.

Human Medicinal Products

Mandatory CTD Format for Renewals: Key Guidelines for Human Medicinal Products

As of January 1, 2007, all renewal and variation applications must be submitted in the CTD format. Cross-references to documentation in the “old” format are accepted for these applications. Reformatted documentation should be submitted either simultaneously with or separately from the variation or renewal application.

This guide also includes special guidelines for specific human medicinal products and references to the European Community’s guidelines on quality, safety, and efficacy. Applicants should consider these guidelines and updates when preparing their applications. Additional guidelines are available for herbal products, biosimilar products, and the plasma master file.

The updated CTD guide provides essential information to applicants for navigating the licensing process. This guide will help applicants prepare their dossiers by international standards, facilitating a smoother regulatory process.

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Resource: Turkish Medicines and Medical Devices Agency, June 05, 2024

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