THE BOARD OF THE EURASIAN ECONOMIC COMMISSION HAS PASSED TWO GUIDELINES THAT REGULATE THE PROCESS OF PHARMACEUTICAL DEVELOPMENT AND VALIDATION OF EQUIVALENT EFFICACY AND SAFETY OF MICELLAR DRUGS AND NANODRUGS.
The documents establish a standard in relation to the quality indicators inspection scope for duplicated drugs in these dosage forms compared to the original drugs. The guidelines also contain instructions on the development of specifications, establish the types of laboratory tests, including those with direct human involvement. The introduction of these standards aims to prevent circulation of insufficiently studied pharmaceuticals.
The new regulations have no analogues in the national legislation of the EAEU member states and will serve as an example of rules developed within the single market paradigm.
A separate panel discussion, The Past and the Future of the EAEU Single Market Integration, to be held at the V All-Russian GMP Conference in partnership with PRO.MED.CS Praha a.s. will be dedicated to the matters of balance between the Eurasian and national requirements in the EAEU member states as well as matters of legislation harmonization.