The Ministry of Health of the Russian Federation proposed to approve indicators of the risk of violation of mandatory requirements in the implementation of federal state control (supervision) of biomedical cell products circulation. The draft of the corresponding order is published at regulation.gov.ru.
The authors of the document believe that a tenfold or higher increase in the number of reports in a calendar year on side effects and adverse reactions during the use of a biomedical cell product should be used as an indicator. In the statistics, it is necessary to take into account both messages from the owners of registration certificates and from other persons authorized to collect such information. The data will be compared with the same indicators of the previous year.
The risk indicator is a value of parameter of the controlled object beyond which the negative consequences of activities significantly increase and a threat of harm to the life and health of citizens may emerge.