128 draft pharmacopoeial monographs were approved in EAEU this year

| By | EAEU, Pharmacopeia

More than 150 drafts of general pharmacopoeial monographs were reviewed by the Pharmacopoeia Committee of the Eurasian Economic Union in 2017. 128 drafts have been approved and submitted for public discussion.

The general monographs of EAEU Pharmacopoeia establish the requirements for methods used in the quality control of drugs and equipment required for testing their quality, packaging materials, reagents, dosage forms, pharmaceutical substances, standard samples, auxiliary substances used in the manufacturing of medicinal products intended for circulation in the Union. In essence, these are the standards required for ensuring the safe use of drugs by the patients, effective work of manufacturers and state control authorities. They will help to create the conditions for free movement of pharmaceutical products within EAEU and their exports to third countries.

The members of the Pharmacopoeia Committee discussed the comments received from the EAEU member states following the public discussion of some drafts, including Clarity and Degree of Opalescence of Liquids, Degree of Coloration of Liquids, Potentiometric Determination of pH, Relative Density, Absorption Spectrophotometry in the Ultraviolet and Visible Regions, Gas Chromatography, Detection and Measurement of Radioactivity, Abnormal Toxicity, and Bacterial Endotoxins. They noted that it would be advisable to include 17 draft general pharmacopoeial monographs on veterinary medicine submitted by the Russian side in the first issue of volume I of the Pharmacopoeia of the Eurasian Economic Union after their review and approval by the Pharmacopoeia Committee.

The review of the draft general pharmaceutical monographs included in the first issue of volume I of EAEU Pharmacopoeia is expected to be completed in Q1 2018.

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