The Russian government has recently revised regulations regarding the formation of the essential drugs list, placing a priority on domestically manufactured medications. The new regulations introduce a new approach to comprehensively evaluate a drug submitted for inclusion in the list of essential drugs and expensive drugs. Under the new rules, drugs will be awarded 7 points for all stages of production, including the creation of the final dosage form, even without the synthesis of the active substance molecule during the production of pharmaceutical substances.
Furthermore, if the Ministry of Health commission rejects a manufacturer’s application for the inclusion of their product in the lists, the manufacturer will have the opportunity to submit a revised study with more comprehensive information about the drug. This approach aims to encourage companies to submit complete and high-quality studies of their products.
“In general, these decisions will ensure the stability of drug supply amidst sanctions pressure. Prices for drugs included in the essential drugs list are regulated by the state. These drugs are used to treat patients under the state guarantees program, which provides free medical care to citizens. The essential drugs list currently comprises over 820 medicines,” as stated in the publication on the government website.
At the beginning of 2024, the Ministry of Health of the Russian Federation proposed amendments to the regulations governing the formation of the essential drugs list, with the aim of reducing the risk of shortages. The proposed changes included two new reasons for excluding a drug from the list: the drug not being used in existing treatment regimens and the drug or its residues not being present one year after its introduction into civil circulation.
Additionally, the document mentioned reducing the time frame for decision-making regarding additions to the list. The maximum period for documentary examination preparation should not exceed four working days, instead of the previous seven, while the comprehensive assessment by the examination center and expert organizations should take 15 working days, rather than the previous 30.
