The European Medicines Agency (EMA) is in the process of implementing the standards developed by the International Organization for Standardization (ISO) for the identification of medicinal products (IDMP). Following a phased implementation process, pharmaceutical companies will be required to submit data on medicines to EMA in accordance with these formats and terminologies.
The ISO IDMP standards are a set of common, global standards for data elements, formats and terminologies to uniquely identify and exchange information on medicines.
Commission Implementing Regulation (EU) No 520/2012 (articles 25 and 26) obliges Member States, marketing authorisation holders and EMA to make use of the terminologies defined in ISO IDMP standards from July 2016.
The five ISO IDMP standards should simplify the exchange of information between all stakeholders, enhancing interoperability of systems at European Union (EU) level and internationally.
They define data elements and structures for unique identification and exchange of regulated information on:
- substances (ISO 11238);
- pharmaceutical dose forms, units of presentation, routes of administration and packaging (ISO 11239):
- units of measurement (ISO 11240);
- regulated pharmaceutical product information (ISO 11616);
- regulated medicinal product information (ISO 11615).
In parallel, EMA is implementing the messaging standards developed by Health Level Seven (HL7), which define a format for the electronic exchange of data that is compliant with the ISO IDMP technical specifications.
The format is based on the existing HL7 standard, the Common Product Model.
Implementing the ISO IDMP standards in the EU will impact on many areas of the pharmaceutical regulatory environment, both in the EU and other regions.
The transition requires a coordinated programme involving all key stakeholders, including EMA, national competent authorities, industry representatives and software vendors.
This is to ensure the consistent implementation of the regulation in the EU and alignment between the EU and the United States, currently the only region outside the EU to adopt the ISO IDMP standards.
Substance, product, organisation and referential (SPOR) master data
The underlying challenge of IDMP is fundamentally a master data challenge.
EMA's approach to implementing the ISO IDMP standards is based on the four domains of master data in pharmaceutical regulatory processes: substance, product, organisation and referential (SPOR) data.
EMA will establish ISO IDMP compliant business services for the central management of data in each of the four SPOR areas. These include data management services for:
- substance data: harmonised data and definitions to uniquely identify the ingredients and materials that constitute a medicinal product;
- product data: harmonised data and definitions to uniquely identify a medicinal product based on regulated information (e.g. marketing authorisation, packaging and medicinal information);
- organisation data: data comprising organisation name and location address, for organisations such as marketing authorisation holders, sponsors, regulatory authorities and manufacturers;
- referential data: lists of terms (controlled vocabularies) to describe attributes of products, e.g. lists of dosage forms, units of measurement and routes of administration.
EMA's master data management roadmap aligns with the approach to implementing the ISO IDMP standards:
The initiative aims to optimise and build on the current data governance, business processes and technology platforms in place at EMA, while considering wider stakeholder data requirements.
EMA will update the roadmap in due course to reflect the latest agreed strategy for SPOR implementation.
Benefits of SPOR data management services
Implementing the SPOR data management services offers a number of key benefits for the regulation of medicines:
- more efficient regulatory action and decision-making, thanks to improved data integrity and reliability;
- increased data quality and simplification of data management practices, since data will be reviewed, assessed and approved as part of the new data operating model;
- regulatory requirements can be met more effectively, by reducing data silos and improving interoperability across EU systems;
- operational savings and efficiencies can be achieved, as pharmaceutical companies only need to supply regulatory data once, which will be re-used across different procedures and regulators.
These operational benefits should have a positive impact on public health and safety.
However, the full benefits of SPOR will be visible incrementally as EMA completes its different phases and exploits opportunities for integration with its regulatory partners, for example by enabling the SPOR services to support regulatory submissions to the Common European Single Submission Portal.
For a more detailed introduction to the ISO IDMP standards, their purpose and potential uses in the regulatory context, see:
Engaging with stakeholders
The Agency and the European medicines regulatory network are pursuing an open dialogue with industry and all stakeholders to discuss aspects of implementing the ISO IDMP standards in the EU.
Stakeholders include national competent authorities, software vendors, the United States Food and Drug Administration, the European Directorate for the Quality of Medicines and HealthCare, the European Commission and will soon extend to the Swiss Agency for Therapeutic Products and veterinary stakeholders.
A webinar on 4 August 2016 supported industry in understanding the SPOR data services, including benefits and high level changes, implementation timelines and engagement approach:
EMA has established an ISO IDMP Task Force with the involvement of terminology organisations, software vendors and developers of medicinal product dictionaries or databases.
The task force is responsible for advising on the planning, development, implementation and maintenance of the ISO IDMP standards in the EU, in line with requirements defined at international level and based on agreed EU implementation principles.
For more information on meetings of the ISO IDMP Task Force:
- ISO IDMP Task Force meeting (13/12/2016)
- ISO IDMP Task Force meeting (30/06/2016 - 01/07/2016)
- ISO IDMP Task Force meeting (19/02/2016)
- ISO IDMP Task Force meeting (25/09/2015)
- ISO IDMP Task Force meeting (12/6/2015)
- ISO IDMP Task Force meeting (31/3/2015)
EMA publishes the agendas and minutes of the task force meetings on the meeting pages.
The minutes are made available following their adoption at the subsequent task force meeting. The terms of reference for the task force is also available, as adopted by the Data Integration Steering Committee.
In June 2015, EMA held a dedicated ISO IDMP Information Day on the activities, discussions and outcomes of the ISO IDMP Task Force, as part of the Agency’s activities to communicate efficiently and transparently to all interested stakeholders.
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