The drafts of 36 monographs for EAEU Pharmacopoeia have been approved

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The documents will soon be available for preliminary review and discussion on the website of the Eurasian Economic Commission (EEC). Their contents were discussed at the meetings of the working group on common approaches to regulation of circulation of medicines and Pharmacopoeia Committee of the EAEU under the chairmanship of Valery Koreshkov, the Member of the EEC Board (Minister) for Technical Regulation.

Volume I of the Union’s Pharmacopoeia will include the general monographs that are expected to be grouped by sections on chemical, physical and physico-chemical methods of analysis, tests for the limits of impurities, methods of quantification and biological testing, and some others. The Guidance governing the activities of the Union’s Pharmacopoeia Committee was also discussed.

Valery Koreshkov noted a significant amount of work done by the Eurasian Economic Commission to elaborate the Pharmacopoeia of the Union, including in the area of international cooperation. The EEC Minister stressed the need for early preparation of Volume I monographs for Pharmacopoeia of the Union, taking into account the provisions of the Concept for Harmonization of Pharmacopoeias in EAEU Member States.

Pharmacopoeia Committee of the Eurasian Economic Union was established in 2017 to elaborate and prepare for adoption the EAEU Pharmacopoeia as a core set of requirements for the quality of medicinal products.

SOURCE: gmpnews.ru
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