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 (updated)
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:
Phased implementation (updated)
The European Commission, EU Network Data Board and EU ISO IDMP Task Force endorsed a phased implementation of the ISO IDMP standards.
This allows lessons learnt in each phase to be applied to later phases, processes and systems to mature over time and stakeholders to gain an understanding prior to full roll out.
Referentials and organisations data management services
In the preparation phase, EMA is preparing to launch the referentials data management service (RMS) and organisations data management service (OMS) in 2017.
Meanwhile, EMA has established the infrastructure for delivering the SPOR services and delivered an internal release of RMS in June and OMS in October 2016.
This enables EMA to prepare the content of the organisations dictionary (a list of organisations with their physical locations) to support EMA and EU-wide regulatory activities.
EMA is revising the overall programme implementation timelines and will publish the revised version as soon as possible.
EMA will continue to expand theses services incrementally after their initial launch, in their maintenance phase.
Substance and product data management services
These RMS and OMS services lay the data foundations for delivering the substance data and product data management services.
Once they are in place, stakeholders should start preparing to replace their current data submission format, the eXtended EudraVigilance Product Report Message (XEVPRM) format, with the HL7 SPL format based on the ISO IDMP standards, ISO IDMP technical specifications and HL7 Common Product Model.
EMA is working closely with partners in the European regulatory network and industry to develop guidance to define the implementation requirements of the ISO IDMP standards and terminologies in the EU.
This is known as the EU IDMP implementation guide for the submission of data on substances and products.
Once the RMS and OMS services go live, a transition phase will begin containing two sub-phases:
- Product and substance data pre-submission:
- ISO documents and EU implementation guides are expected to be finalised and published;
- marketing authorisation holders, national competent authorities and EMA should align their systems with the released terminologies for referential and organisation data and register any new terms to expand the controlled vocabularies required for the submission of substance and product data;
- marketing-authorisation holders will still have to submit in the XEVPRM format during this phase to comply with their regulatory obligations under Article 57 of Regulation 726/2004.
- Product and substance data submission:
- EMA will convert existing medicinal product and substance entities into the new HL7 format and assist industry in the submission of IDMP products via the new format;
- pharmaceutical companies will be required to confirm this conversion performed by EMA, and to enrich the data with additional information;
- the XEVPRM format will then be decommissioned and the new format will become mandatory to comply with Article 57 data submission requirements. The Agency will provide a detailed plan, including details of what data is to be submitted, and communicate when the new format will become mandatory well in advance of any change.
In the maintenance phase, EMA will continue to expand and manage the controlled vocabularies for referential, organisation and substance data within the respective data services.
Subsequent iterations of products will be implemented as required to fully complete the implementation of the ISO IDMP standards.
Development of the EU implementation guide is delayed due to a delay in finalisation of the ISO technical specifications until the first quarter of 2017 at the earliest.
Once EMA has published the EU implementation guide, there will be twelve months until EMA launches a first iteration of these data management services and a further six months until they become mandatory.
Preparing for the SPOR data management services (updated)
The launch of the organisation and referential management services will bring about changes in six key areas for stakeholders:
- new ways of accessing SPOR data;
- data stewards managing SPOR data;
- data content that will be available at go-live then gradually expanded;
- new OMS and RMS operating models;
- EMA IT service desk to support stakeholders;
- ongoing data management activities.
Their impact on individual national competent authorities and pharmaceutical companies will vary depending on the size, infrastructure and complexity of systems and processes in these organisations.
National competent authorities and industry need to understand what is changing centrally and draw up implementation plans based on their expected impact.
For more information on the six areas of change brought in by the OMS and RMS services, see:
- SPOR data management services - high level changes
- Organisations management services (OMS) operating model
- Referentials management services (RMS) operating model
It will become mandatory to use the SPOR services at different times for different regulatory procedures.
The launch of OMS and RMS will not immediately change any regulatory submission processes.
However, EMA is consulting stakeholders on the benefits of making changes to certain regulatory submission procedures. EMA will provide more information on any such changes when they go ahead.
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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