Uzbekistan simplifies import procedures for certified medicines

As it was previously reported, on 3 November President Shavkat Mirziyoyev reviewed a presentation on improving medical care for children with rare (orphan) diseases, as well as the progress of reforms and new projects in the pharmaceutical sector.

The president was briefed on a new procedure for the state registration of medicines and medical devices.

The new mechanism envisions establishing production through technology transfer, enabling foreign pharmaceutical companies to manufacture their products using local facilities and complete state registration under an accelerated process.

In addition, conditions are being created for the introduction of new types of biotechnological cell-based medicines into medical practice. These innovative products are designed for the treatment of damaged tissues, the cultivation of individual organs, and the restoration of the body’s functional capabilities.

Clinical trials of generic drugs and the assessment of their outcomes will be conducted in accordance with international standards, while the registration period for such medicines will be reduced. Medical devices in the first safety class – except those that are sterile, measuring, or invasive – will be exempt from laboratory and clinical testing.

Alisher Temirov, Director of the Center for the Safety of Pharmaceutical Products, told the Oʻzbekiston 24 TV channel that the Cabinet of Ministers’ resolution introducing the new registration procedure for medicines and medical devices has been aligned with international standards.

“Differentiated registration mechanisms have been introduced for four safety categories. The application review period for the first and safest category has been reduced from 150 to 60 days, for the second – to 90 days, and for the third and fourth, which are considered higher-risk categories – to 120 days,” he explained.

According to Temirov, the new mechanism will ensure the availability of safe medicines for the population, enhance the export potential of local manufacturers through an accelerated registration process, and simplify the import of certified pharmaceutical products from developed countries.