Overview
ISO/TR 18728:2025 - "Health informatics - Global medicinal product and ingredient and batch registration as part of identification of medicinal products (IDMP)" is a Technical Report that surveys existing practices for monitoring healthcare supply chains and discusses the potential benefits and pathways for expanding IDMP to include global identifiers for medicinal products, ingredients and batches. The document reviews traceability tools, medicines verification/authentication systems, safe communication technologies, and options for a global registration system to improve drug safety, traceability and supply continuity.
Key topics and technical highlights
- Scope and intent: Showcases current implementations used in healthcare supply chains and explores options to register products, ingredients and batches at a global level.
- Identifier models: Discussion of identification levels already defined by IDMP standards:
- MPID (medicinal product identifier)
- PCID (packaged medicinal product identifier)
- BAID1 / BAID2 (batch identifiers at outer and primary packaging)
- PhPID (pharmaceutical product identifier) - ISO 11616 recommends PhPID be unique globally.
- Data carriers and traceability:
- Role of DCID (data carrier identifier), prevalence of GS1 / GTIN®, and interoperability with other systems.
- Use of EPCIS (electronic product code information services) and other traceability frameworks.
- Regulatory context: Reviews regulatory drivers such as the EU Falsified Medicines Directive and the US Drug Supply Chain Security Act and how they intersect with global IDMP initiatives.
- Standards landscape: Summarizes related supply chain and IDMP standards (see Related Standards) and existing systems like GSRS/GSID for substances.
- Challenges & pathways: Addresses operational, technical and governance considerations for moving from distributed/local batch management to a global registration model.
Practical applications and users
ISO/TR 18728:2025 is relevant for:
- Regulatory authorities (national medicines agencies, EMA) evaluating global registration models and harmonized identifiers.
- Pharmaceutical manufacturers planning serialization, batch reporting and global supply chain visibility.
- Healthcare supply chain managers and distributors implementing traceability, recalls, and anti-counterfeiting measures.
- Health IT and serialization vendors integrating IDMP data flows with DCIDs, EPCIS and GTIN-based systems.
- Policymakers and standards bodies considering interoperability and cross-border medicine safety initiatives.
Practical use cases include global batch traceability, targeted recalls, counterfeit detection, cross-border prescribing support, and improved supply shortage management.
Related standards
Keywords: ISO/TR 18728:2025, IDMP, identification of medicinal products, global identifiers, batch registration, supply chain traceability, GTIN, EPCIS, pharmaceutical serialization.