EAEU approves the drafts for eleven monographs of its Pharmacopoeia

Print 03 May 2017
GMP News

The drafts of eleven general pharmacopoeia monographs of the Eurasian Economic Union (EAEU) Pharmacopoeia, the main set of requirements for the quality of drugs, were approved by the Pharmacopoeia Committee of the Union at a meeting held in the Eurasian Economic Commission on April 27.

After the adoption of the Union Pharmacopoeia, these pharmacopoeia monographs will establish common requirements for the methods of quality control, equipment required for drug quality testing, packaging materials, reagents, dosage forms, pharmaceutical substances, standard samples, and excipients used in the manufacturing of medicinal products intended for circulation within EAEU. The general pharmacopoeia monographs will be included in the first issue of volume I of the Pharmacopoeia of the Eurasian Economic Union.

The meeting approved the schedule for preparing the internal documentation and schedule for the meetings of EAEU Pharmacopoeia Committee. These meetings will be held on a monthly basis and, once a quarter, they must be attended in person.

According to the schedule, eleven draft documents are planned for elaboration this year, including the requirements for expert assessment of the drafts of general monographs and other monographs, lists of standard samples of the Union Pharmacopoeia and normative documentation accompanying the standard samples, etc. They will regulate in detail the procedures for preparing pharmacopoeia monographs and the work of the members of the Pharmacopoeia Committee.

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