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

Area of Science:

• Pharmaceutical Sciences
• Regulatory Affairs
• Data Standardization

Background:

• Global pharmaceutical market faces challenges in consistent medicinal product identification and classification across regions.
• The International Organization for Standardization (ISO) established Identification of Medicinal Products (IDMP) standards to address these inconsistencies.
• Standardization is crucial for global regulatory harmonization and data exchange.

Purpose of the Study:

• To explore the feasibility of introducing global dose form attributes for worldwide standardization of medicinal products.
• To define and apply standardized dose form characteristics, including administrable basic dose form, administration method, intended site, and release characteristics.
• To improve the consistency and accuracy of medicinal product data within the IDMP framework.

Main Methods:

• Defined global dose form attributes in collaboration with the European Directorate for the Quality of Medicines (EDQM).
• Applied these attributes to medicinal product data from nine countries, covering six different dose form terminologies.
• Developed a mapping process to link local dose form terminologies to the global attributes.
• Established business rules for assigning global dose form attributes based on study results.

Main Results:

• Global dose form attributes were successfully assigned to over 99% of medicinal products analyzed.
• The mapping process significantly improved the efficiency and accuracy of attribute assignment.
• The study demonstrated the successful application of a standardized approach across diverse national terminologies.

Conclusions:

• Global dose form attributes are feasible and effective for standardizing medicinal product information worldwide.
• Mapping local terminologies to global attributes is a key strategy for successful implementation of IDMP standards.
• This work provides a foundation for consistent global medicinal product identification and regulatory data management.