Advancing Global Harmonization: Implementing Global Dose Form Attributes for Medicinal Products Identification.

Abstract

The global pharmaceutical market includes a wide range of medicinal products, which makes it difficult to achieve consistent identification and classification across different regions. To address this, the International Organization for Standardization (ISO) developed five standards that together create a framework for the Identification of Medicinal Products (IDMP). Implementing the ISO IDMP standards globally necessitates collaboration to ensure consistent data. As part of these efforts, investigations were conducted to explore the feasibility of introducing global dose form attributes, which aim to standardize dose forms worldwide. These characteristics, defined by the European Directorate for the Quality of Medicines (EDQM), include the administrable basic dose form, administration method, intended site, and release characteristics. The global dose form attributes were successfully applied to data from nine countries, representing six dose form terminologies or lists, and were successfully assigned to over 99% of medicinal products. The process of assigning global dose form attributes was improved by mapping local dose form terminologies to global dose form attributes. The results from these studies were used to develop business rules for assigning the global dose form attributes.