First Volume of the State Pharmacopoeia's Second Edition Completed and Submitted for Approval

The first volume of the second edition of the State Pharmacopoeia of the Republic of Uzbekistan has been completed. Comprising nearly 450 general pharmacopoeial chapters, the volume was developed in harmonization with the world's leading pharmacopoeias — the World Health Organization's International Pharmacopoeia (Ph. Int.), the European Pharmacopoeia (Ph. Eur.) and the United States Pharmacopeia (USP). A draft order for its approval has been submitted to the Ministry of Health.

Work on the volume rested on two international instruments: the agreement between the state institution “Center for Safety of Pharmaceutical Products” and the European Pharmacopoeia granting the right to reproduce and harmonize the texts of the European Pharmacopoeia in creating the State Pharmacopoeia, and the contract signed with the United States Pharmacopeial Convention (USP) on granting rights to adopt the United States Pharmacopeia–National Formulary, together with the accompanying Memorandum of Understanding.

The chapters were selected through a comparative analysis of the amendments, additions, withdrawn texts and chapters currently in force across editions 9 to 12 of the European Pharmacopoeia. The analysis drew on data from the EDQM's Pharmeuropa platform and the decisions of the sessions of the European Pharmacopoeia Commission. Over the five years since the first volume was developed, the European Pharmacopoeia had introduced 131 new monographs, revised and supplemented 875, and withdrawn 37 from use — six of which were found to relate directly to the State Pharmacopoeia.

The principal additions incorporated into the first volume of the new edition include:

• 17 new chapters of the European Pharmacopoeia and 30 new chapters of the United States Pharmacopeia;
• 17 chapters mutually harmonized by the European and U.S. pharmacopoeias within the Pharmacopoeial Discussion Group (PDG), together with 14 chapters provided by the USP as their alternatives;
• more than 200 supplements and amendments, along with the harmonization, revision and updating of nearly 4,000 reagents included in the volume.

In preparing the volume, the Editorial Board, the Editorial Council and the Secretariat of the State Pharmacopoeia, together with specialized expert commissions across 11 fields and their working groups, held more than 50 meetings. These addressed some 200 issues and reviewed around 450 draft chapters, which — following expert approval — were recommended for inclusion in the State Pharmacopoeia; 40 sets of meeting minutes were formalized.