Guideline On Medicine Priority Assessment Has Been Updated

In accordance with the Regulation on Licensing of Human Medicinal Products, the Guideline on the Working Procedures and Principles of the Priority Assessment Board for Human Medicinal Products ("Guideline"), which sets out the procedures and principles regarding the prioritization applications submitted to the Turkish Medicines and Medical Devices Agency ("Agency") and the working of the Priority Assessment Board for Human Medicinal Products ("Board") established within the Agency, was updated and published on the Agency's website on June 7, 2024.

First, the article of the Guideline on the scope was amended, and hybrid marketing authorization applications which are based partly on the data of the reference product and partly on the data obtained from the studies of the new product, were included in the scope of the Guideline. It has been stated that prioritization applications can also be made for applications made for imported or licensed human medicinal products,