International Harmonization of the State Pharmacopoeia

The globalization of the pharmaceutical sector is increasingly bringing to the fore the need for international harmonization of the safety, efficacy and quality requirements for medicines. The State Pharmacopoeia of the Republic of Uzbekistan takes a consistent part in this process, methodically integrating the texts of recognized leading pharmacopoeias into the national system.

Harmonization Mechanisms

International harmonization is pursued through mechanisms at the global and regional levels:

• Global mechanisms — within the work of WHO, FIP, the World Medical Association and CIOMS;
• Regional mechanisms — within the European Union and the Council of Europe.

Types of Harmonization

Harmonization is distinguished both by the object it covers and by the degree of adoption:

• Prospective — applied to new methods or substances not previously standardized;
• Retrospective — applied to monographs already in force;
• Full mechanism — complete adoption of the text without significant changes;
• Selective (partial) mechanism — adoption of selected parts with agreed changes.

The Ph. Eur. and USP Approaches

Texts of the European Pharmacopoeia (Ph. Eur.) are adopted on the basis of the prospective type and the full mechanism: the content of the text, the style of presentation, and the numbering and names of the sections and monographs are fully preserved.

For USP texts, both the full and the selective mechanisms are used, as well as prospective and retrospective approaches.

The Benefits of Harmonization

Properly organized harmonization reduces the need for repeated control, simplifies the quality-control process and makes it less costly.