PD CEN ISO/TS 21405:2026

This standard PD CEN ISO/TS 21405:2026 Health informatics. Identification of medicinal products. Methodology and framework for the development and representation of IDMP ontology is classified in these ICS categories:

• 35.240.80 IT applications in health care technology

This document describes a standardized methodology and framework for the development and representation of an ontology that supports a global, open-source approach to implementing the ISO standards on the identification of medicinal products (IDMP) (ISO 11615, ISO/TS 20443, ISO/TS 20451, ISO 11238; ISO/TS 19844, ISO 11239, ISO/TS 20440, and ISO 11240). Realization of the full potential of IDMP requires fully self-describing data. For this purpose, this document describes a methodology and framework that complements the existing conceptual and logical models in the ISO documents on IDMP with an IDMP ontology that enables deep, semantic interoperability based on findable, accessible, interoperable and reusable (FAIR) data principles. This methodology and framework enhance the usage of the IDMP data model as the foundation of medicinal product identification and will ultimately enable collaboration towards drug safety and overall operational efficiency. This document also describes a methodology for the agile adaptation of the ISO documents on IDMP in connection with cross-jurisdictional IDMP-related legislation and initiatives. This document is intended to be complementary to and independent from formal regulatory guidance. Thus, it enables cross-jurisdictional consistency and supports stakeholders in their regional implementations of IDMP standards. This document does not mandate any specific ontology as an implementation tool, nor is it an instructional guideline on how to build ontologies, which is out of scope of this document. This document includes key use cases described in the ISO documents on IDMP ISO 11615, ISO 11238 and ISO/TS 19844, as well as further use cases arising from the comprehensive deployment of the ISO documents on IDMP via an ontological framework. Thus, an ontology that represents the IDMP standards aims to cover the complete collection of ISO standards on IDMP regarding key interoperability issues that implementing stakeholders are facing.

PD CEN ISO/TS 21405:2026 - Health Informatics: Identification of Medicinal Products

Standard Number: PD CEN ISO/TS 21405:2026

Pages: 42

Release Date: April 9, 2026

ISBN: 978 0 539 27707 4

Status: Standard

Overview

The PD CEN ISO/TS 21405:2026 is a pivotal standard in the realm of health informatics, focusing on the identification of medicinal products. This standard provides a comprehensive methodology and framework for the development and representation of the IDMP (Identification of Medicinal Products) ontology. As the healthcare industry continues to evolve, the need for precise and standardized identification of medicinal products becomes increasingly critical. This standard addresses that need by offering a structured approach to the development of ontologies that facilitate the accurate identification and classification of medicinal products.

Key Features

• Comprehensive Framework: The standard outlines a detailed framework for the development of IDMP ontology, ensuring consistency and accuracy in the identification of medicinal products.
• Methodological Approach: It provides a robust methodology that guides the creation and representation of ontologies, making it easier for healthcare professionals to manage and utilize medicinal product data.
• Enhanced Interoperability: By standardizing the identification process, this document enhances interoperability across different healthcare systems and platforms, facilitating seamless data exchange and integration.
• Future-Proof Design: The framework is designed to accommodate future advancements in healthcare technology and informatics, ensuring its relevance and applicability in the years to come.

Benefits

The implementation of the PD CEN ISO/TS 21405:2026 standard offers numerous benefits to healthcare organizations, professionals, and patients alike:

• Improved Patient Safety: By ensuring accurate identification of medicinal products, the standard helps reduce medication errors and enhances patient safety.
• Streamlined Operations: Healthcare providers can streamline their operations by adopting a standardized approach to medicinal product identification, leading to increased efficiency and reduced administrative burdens.
• Global Compatibility: The standard aligns with international best practices, making it suitable for use in healthcare systems worldwide and promoting global compatibility.
• Data Consistency: It ensures data consistency across various healthcare applications, enabling better data management and analysis.

Target Audience

This standard is essential for a wide range of stakeholders in the healthcare industry, including:

• Healthcare Providers: Hospitals, clinics, and other healthcare facilities can benefit from the standardized identification of medicinal products.
• Pharmaceutical Companies: Manufacturers and distributors of medicinal products can ensure compliance with international standards.
• Regulatory Bodies: Government and regulatory agencies can use the standard to enforce consistent identification practices.
• Health IT Professionals: Developers and IT professionals involved in healthcare informatics can leverage the framework to enhance system interoperability.

Conclusion

The PD CEN ISO/TS 21405:2026 standard is a crucial tool for advancing health informatics and improving the identification of medicinal products. By providing a clear methodology and framework, it supports the development of robust ontologies that enhance data accuracy, interoperability, and patient safety. As the healthcare industry continues to embrace digital transformation, this standard will play a vital role in shaping the future of medicinal product identification and management.