The Russian Ministry of Health presented a draft government decree on amending the regulation on state control in the field of drug circulation. The document was published on the regulation.gov.ru portal. The regulation is due to enter into force in March 2022.
The ministry proposes to make the ratio of the number of counterfeit drugs to the total number of drugs produced in Russia during the year a key indicator of state control. If Roszdravnadzor has not received such information during the year, the value of the key indicator will be zero. It is also planned to set the target value of the key indicator — 0.01 or less.
Also, the key indicator should be the ratio of the number of reports of side effects that are not specified in the instructions, and serious adverse reactions in relation to the total number of such messages sent to Roszdravnadzor by drug license holders per year. In the absence of such data, the key indicator will also be equal to zero, similarly, the target value will be 0.01 or less.
The key indicators are based on the level of minimizing harm to legally protected values, the level of eliminating the risk of damage, and target values for the key indicator, which is noted in the explanatory note to the document.