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). These are a set of common global standards for data elements, formats and terminologies for the unique identification of and the exchange of information on medicines. Following a phased implementation process, pharmaceutical companies will be required to submit data on medicines to EMA in accordance with these formats and terminologies.
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 will require 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 that practices between the EU and the United States, currently the only region outside the EU to adopt the ISO IDMP standards, are aligned with one another.
Master data approach
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, describing the ingredients of a medicine;
- product data, describing the marketing and medicinal information relating to a product;
- organisation data, providing the contact details of organisations and individuals responsible for various aspects of a medicine;
- referential data, providing controlled vocabularies (e.g. dosage, pharmaceutical forms, country codes, package codes, weight codes) for a medicine, which are explicitly defined for use in Europe.
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 the SPOR implementation.
The European Commission, the European Union (EU) Network Data Board and the EU ISO IDMP Task Force have endorsed a phased implementation of the ISO IDMP standards. This approach will allow lessons learnt during each phase to be applied to subsequent phases, processes and systems to mature over time and stakeholders to gain an understanding prior to the full roll out.
EMA will launch the referentials management service in the third quarter of 2016, followed by an initial release of the organisations management service. EMA will continue to expand theses services incrementally after their initial launch.
Once these services are in place, stakeholders should start preparations 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. In parallel, EMA will implement the substance data and product data management services.
Implementation will be structured in three main phases: preparation, transition and maintenance.
In the preparation phase, EMA will establish the necessary technical services to support the submission of organisation and referential data. EMA will develop and release a set of controlled vocabularies and an organisation dictionary.
Meanwhile, EMA will continue to work closely with partners in the European regulatory network and the pharmaceutical industry to develop guidance to define the implementation aspects and requirements of the ISO IDMP standards and terminologies in the EU (EU IDMP implementation guides) for the submission of data on substances and products.
The transition phase will begin once EMA has confirmed that the organisation and referential data services have gone live. It will have two sub phases:
- Product and substance data pre-submission: ISO documents and EU implementation guides are expected to be finalised and published. Due to a delay in the finalisation of the ISO technical specifications, which are now not expected to be published before the first quarter of 2017, the development of the EU implementation guide and its implementation in the related master data management services in the EU will take place later than originally planned. The substance and product data submission phase cannot start before the first quarter of 2018.
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.
Engaging with stakeholders (updated)
The Agency and the European 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 will support 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:
- Fifth ISO IDMP Task Force meeting (30/06/2016 - 01/07/2016)
- Fourth ISO IDMP Task Force meeting (19/02/2016)
- Third ISO IDMP Task Force meeting (25/09/2015)
- Second ISO IDMP Task Force meeting (12/6/2015)
- First 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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