The European Medicines Agency (EMA) is preparing data management services in the four domains of master data in pharmaceutical regulatory processes: substance, product, organisation and referential (SPOR) data. The SPOR services will support the implementation of the standards developed by the International Organization for Standardization (ISO) for the identification of medicinal products (IDMP).
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.
For more information, see Implementation of ISO IDMP standards.
Referentials and organisations data management services
EMA is preparing to launch the referentials data management service (RMS) and organisations data management service (OMS) in the preparation phase in 2017.
Meanwhile, EMA 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.
Call for expressions of interest: RMS and OMS user acceptance testing (new)
EMA is organising external user acceptance testing (UAT) of the RMS and OMS from 27 March to 7 April 2017.
The exercise is aimed at terminology maintenance organisations, software vendors, service providers and developers of medicinal product dictionaries/databases.
Interested parties should send an email to firstname.lastname@example.org by 17:00 (UK time) on23 March 2017 with 'RMS and OMS UAT: expression of interest' in the subject line, to express their interest in taking part in the testing.
EMA will inform the successful candidates by 24 March 2017.
For more information, see:
Guidance for industry
The launch of the RMS and OMS 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.
Substance and product data management services
The 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 medicines 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.
EMA will continue to expand and manage the controlled vocabularies for referential, organisation and substance data within the respective data services in the maintenance phase.
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.
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