The government of the Russian Federation has announced a continuation of simplified pathways for the registration and import of medicines, extending these measures through the end of 2025. This decision, conveyed by Prime Minister Mikhail Mishustin, comes in response to ongoing disruptions in global supply chains and the need to ensure timely access to essential medications for residents. The move aims to keep drug manufacturers moving quickly, reducing bureaucratic hurdles that could delay bringing medicines to the domestic market.
Central to the extension is the expedited processing for two main categories. First, it covers the registration of analogues of medicines already available within Russia, helping manufacturers align with domestic regulations while ensuring comparable safety and efficacy profiles. Second, it streamlines the authorization to import original drugs that bear non-Russian labeling on their packages, which would require translation into Russian before sale. The overarching purpose is to maintain a steady supply of medications in pharmacies and hospitals, even amid international tensions and logistical constraints.
Prime Minister Mishustin stressed that these measures are designed to improve patient access to medicines, particularly for those whose treatment depends on timely delivery of specific drugs. By shortening approval timelines and reducing duplicative paperwork, the government seeks to prevent shortages and provide physicians, pharmacists, and patients with reliable options. The approach also supports manufacturers by giving clearer expectations and faster feedback loops throughout the registration and import process.
Under Russia’s current framework, drugs that are either imported or produced domestically must undergo state registration. The simplified procedures are intended to accelerate this process by ensuring that all necessary documentation can be secured promptly, without compromising safety or regulatory oversight. This balance between speed and compliance is a key feature of the policy, reflecting the government’s goal of safeguarding public health while maintaining industry momentum during periods of external disruption.
Historically, the state has taken concrete steps to facilitate international pharmaceutical trade. In 2022, the State Duma enacted a law permitting the importation of foreign medicines in foreign packaging, a change that acknowledged practical realities in global pharmaceutical supply chains. The law also requires foreign manufacturers to provide at least six months’ notice to the Ministry of Health before halting production or import of drugs into Russia. These provisions create predictability for the domestic market and help healthcare providers anticipate supply changes, ensuring continuity of care for patients relying on imported therapies.