The Russian Ministry of Health has developed a draft government resolution that suggests enabling expedited state registration of medications not produced in Russia, without the need to reference shortages. As noted in the explanatory note, accelerated registration will be possible “irrespective of the current availability and stock levels of drugs in medical and pharmacy organizations, as well as the volumes of introduction into civil circulation and production volumes.”
In the event of the initiative being endorsed, when filing a registration application for a biological drug, a legal entity will need to furnish the Ministry of Health with details regarding the localization of its production, encompassing the synthesis of the active substance molecule in the pharmaceutical substance production, the manufacturing of the final dosage form, the provision of primary and secondary packaging of the product, and the execution of release quality control. When discussing chemically derived drugs, it’s crucial to gather information regarding the production site of the final dosage form, the availability of primary and secondary packaging, as well as the execution of quality control during release.
