EAEU established approaches to analysing impurities in medicines
05.10.2022
The Board of the Eurasian Economic Commission approved the Requirements to conducting analysis (tests) of medicines in terms of assessing and controlling the impurity content.
The Requirements establish approaches to evaluating safety and standardizing the content of medicine impurities including those that are formed during their storage. That allows to control the quality of medicines both when they are produced and when they are sold and used.
The approaches set out in the Requirements comply with the international principles of impurity standardization.
"The document will allow to continue the development of the common Union system of requirements to the quality of medicines and to establish unified principles and the procedure for analysing and substantiating a safe level of impurities in medicines in terms of their acceptable daily effect on patients," noted Viktor Nazarenko, EEC Minister in charge of Technical Regulation.