News
Determining special significance of medicines to speed up their registration in EAEU
The Board of the Eurasian Economic Commission approved the Guidelines for Assessing the Special Significance of Medicinal Products for Public Health facilitating an accelerated examination to register them.
The Guidelines allow pharmaceutical manufacturers to justify the use of accelerated registration procedures for medicines based on their uniqueness (lack of other alternative treatments), ability to cure or control severe diseases, prevent disability or reduce mortality in patients.
The document uses objective indicators for assessing the benefits of medicines, which allow to assess how they can prolong life or shorten the period of disability.
Accelerated market launch of medicinal products of special significance will help Member States meet the needs that their healthcare systems and patients have in new highly effective medicinal products.
