The Turkish Medicines and Medical Devices Agency (the “TİTCK”) recently published the Guidelines on Stability Testing of Active Ingredients and Final Products (the “Guidelines”, available here in Turkish), based on the Regulation on Licensing of Medicinal Product for Human Use.
What the Guidelines Say
The Regulation on Licensing of Medicinal Products for Human Use requires the submission of the details and results of the stability tests for active ingredients and final products to the TİTCK when applying for a license.
Stability tests demonstrate how the quality of an active ingredient or a final product changes over time under the influence of a number of environmental factors, such as temperature, humidity and light. With the stability tests, one hopes to determine the retest period for the active ingredient or the shelf life and recommended storage conditions for the final product in question.
The Guidelines lay down the technical specifications for the stability tests of active ingredients and final products, such as the types of tests to be carried out as well as the frequency, storage conditions and the criteria that should be considered when evaluating the resulting data.
The TİTCK continues to provide guidance for companies engaged in pharmaceutical products and medicinal products for human use in relation to their license applications. Companies, therefore, should closely follow the announcements made by the TİTCK and take the necessary steps to ensure compliance with any recent development that may affect their licensing process.