Identification of Medicinal Products (IDMP)

IDMP has been developed by the International Organization for Standardization (ISO) (www.iso.org), in cooperation with the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), Health Level Seven (HL7) and other international stakeholders and experts.

The five IDMP standards, along with their respective technical specifications, will make it possible to uniquely identify and describe medicinal products with consistent documentation and terminologies and to standardize the electronic exchange of medicinal product data between stakeholders. They establish common definitions, common identifiers and common data structures (data elements and their structural relationships):

• ISO 11615 – Medicinal product information
  Focus: Marketing authorization details.
  Includes: Medicinal product identifier (code controlled by the responsible regulatory agency), medicinal product name, authorization holder, manufacturers, packaged product details, dose form, ingredients, therapeutic indications, etc.
• ISO 11616 – Pharmaceutical product information
  Focus: Generation of pharmaceutical product identifiers (PhPIDs).
  Includes: Specifies the data elements and structures that are required for the exchange of regulated information, in order to uniquely identify pharmaceutical products. Products with identical components such as substance, dose form, and strength will have the same PhPID.
• ISO 11238 – Substance identification
  Focus: Unique substance definitions in a scientifically consistent manner.
  Includes: Details on active ingredients, adjuvants, and excipients in medicinal products.
  
• ISO 11239 – Pharmaceutical dose forms, units of presentation, routes of administration and packaging
  Focus: Controlled terminologies.
  Includes: The controlled terminologies to characterize pharmaceutical dosage forms, routes of administration, units of presentation, and packaging.
  
• ISO 11240 – Units of Measurement
  Focus: Standardized and machine-readable units of measurement for medicinal products.
  Includes: Units of measurement to use to define quantitative composition and the strength of a medicinal product.

The benefits of using IDMP focus on five key areas where improvements can be made:

• data quality;
• information sharing;
• safety alerts;
• medicinal product shortages and
• cross product comparisons.

The implementation of IDMP standards impacts overall data quality throughout the medicinal product development value chain by alignment of data and information sources to provide an accurate, single source of truth. Use of the standards and global adoption should improve interoperability by making it easier to share information electronically and communicate using harmonized terminologies. Sharing information using common formats and standards should improve the ability to identify, assess and respond to patient safety or medication alerts and to identify pharmaceutically equivalent products across regions in order to support the mitigation of medicinal product shortages. Lastly, the adoption and use of IDMP standards should facilitate the comparison of medicinal products within and across jurisdictions for pricing and reimbursement, as well as for cross-border healthcare.

Swissmedic is actively participating in a number of international organisations and working groups dealing with development, maintenance and implementation of the IDMP standards, such as:

• ISO TC215 – ISO Technical Committee 215 «Health Informatics»
• IPRP IDMP Working Group – International Pharmaceutical Regulators Programme (IPRP) IDMP Working Group
• GIDWG – Global IDMP Working Group
• In addition, Swissmedic is an observer within several EU/EMA bodies dealing with the European IDMP implementation and participates in the Global Substance Registration System (GSRS) project by the US National Center for Advancing Translational Sciences (NCATS) at NIH (National Institute of Health).

Swissmedic is currently evaluating targets and priorities for the implementation of IDMP standards in connection with the replacement of internal platform systems (see Transformation of Swissmedic platforms TSP).

For the implementation of IDMP standards, Swissmedic will align as far as possible to the EU requirements, while taking into account the Swiss-specific ones. In addition, Swissmedic will ensure the data sovereignty of pharmaceutical and organizational data with its own databases.

Swissmedic is interested in sharing expectations, knowledge, and plans for the future implementation of IDMP standards. First meetings with a pilot group of stakeholders have taken place in 2019 and 2023. Further exchanges are planned.