02 nd Sep Identification of Medicinal Products (IDMP)
IDMP – the latest on the EMA SPOR master data management approach
IDMP – or the Identification of Medicinal Products – is an initiative to standardise the way the pharmaceutical industry refers to medicinal products, providing a universal identification for drugs that can be referenced in individual case safety reports. IDMP will eventually replace the eXtended Eudravigilance Medicinal Product Dictionary (XEVMPD) as the submission standard. Devised by the International Organization for Standardisation (ISO), IDMP is comprised of five information management standards on the use, consumption and packaging of drugs. The standards will ‘specify definitions in terms for all data elements required to uniquely and with certainty identify medical products for human use.’
The IDMP focus, and challenge, is on master data; any information that is considered to play a key role in the core operation of a business and re-used for multiple purposes. The European Medicines Agency (EMA) has identified four domains of master data and together these are known as ‘SPOR’. Adoption of the SPOR operating model will enable the implementation of consistent, centrally maintained ISO IDMP-compliant master data, which will feed regulatory activity across the product lifecycle. Implementation of the four data areas will be phased as part of IDMP and applies to both Human and Veterinary domains.
SPOR consists of:
• S – Substances: Data that describes the ingredients that make up the medicinal product.
• P – Products: Data that describes the marketing authorisation, packaging and medicinal information relating to the product.
• O – Organisations: Data that comprises of the name and address for organisations such as MAH, sponsors, manufacturers, etc.
• R – Referentials: List of terms (controlled vocabularies) used to describe attributes of products e.g. lists of dosage forms, units of measurement, routes of administration.
To facilitate the centralised management of each data area, the EMA have established four separate business services known as the SPOR Management Services.
In parallel, the EMA is implementing the messaging standards that have been developed by Health Level 7 (HL7), which define a format for the electronic exchange of data that is in compliance with the ISO IDMP technical specifications.
The benefits of SPOR will be realised incrementally as all four areas are applied and as new systems to support regulatory activity (e.g. CESP, Clinical Trials Portal) are implemented and
integrated with SPOR data.
• Positive impact on public health and safety due to faster, more efficient reporting of data and consequential decision – making.
• Operational savings and efficiencies as data is only entered once and reused across different procedures and regulators.
• Improved data integrity and reliability.
• Simplification of data management as data is reviewed, assessed and approved as part of the new data operating model.
New ways of accessing data – The SPOR data will be accessible via a web interface. SPOR Application Programming Interfaces (APIs); mechanisms to allow your IT systems to exchange information with the Referentials Management Service (RMS) and the Organisations Management Service (OMS), are expected to be published imminently. EMA Data Stewards – A specialised team at the EMA will manage all the SPOR data on behalf of the network and provide user support. The key activities will include the management of data quality, taking action on change requests and validation of access requests to SPOR services.
OMS Operating Model – A centralised dictionary of Organisations data will be developed and hosted by the EMA who will provide access to stakeholders. A process will be established for Industry to request organisation registration or updates and all data will be validated by the EMA Data Stewards.
RMS Operating Model – The EMA will act as the broker and provide Referentials data services to the EU network. The EMA will host current reference lists from different maintenance organisations including WHO, EDQM, MSSO, BfArM, etc. For new lists, where no maintenance organisation exists, the EMA will assume that role and a process will be established for Industry and other parties to request registration of Terms.
Referentials data will be maintained by the EMA data stewards and will be available in a structured format. Data Content – Initial RMS lists and an OMS dictionary will be available at go-live date however these will be gradually expanded. Data Management – Industry will need to synchronise data in their local systems with RMS and OMS on an ongoing basis and may require amendments to local data to align with any ISO/EU data format changes. EMA IT Service Desk – The EMA IT Service Desk will provide technical support for SPOR data services for all stakeholders.
Communication and Training
Going forward the EMA will develop core communications and training materials for distribution to a Change Network. This network, acting as SPOR programme advocates, will then disseminate the core information to the relevant stakeholders, tailoring to their audience as necessary. The Change Network will identify key contacts who represent stakeholder groups to ensure that communications reach the target. The role of ‘Industry Change Liaison’ was created by the EMA to target industry stakeholders and has been given to representatives from industry associations and vendors drawn from the SPOR Task Force.
Their tasks include:
• Acting as the first port of call for stakeholders across the industry to provide information, answer questions and receive feedback
• Cascading communications from the EMA and reinforcing key messages
• Encourage uptake of training and reinforcing understanding
How Can You Be Involved?
The EMA are making good head way in the implementation of IDMP but companies don’t have to wait for information to come to them. A proactive approach is recommended to ensure you are in the best possible situation at the time of implementation. Some further information on the activities that companies can get involved in now, and what will be expected of them at go-live, is provided below.
Programme participation – Engage with the programme via the Industry Change Liaisons and existing forums (e.g. SPOR Task Force, Sub Groups). Support change management activities (e.g. communication and training), review programme documentation and support planning and execution of user acceptance testing (UATs) when required. The programme documentation for review and UATs will be communicated via SPOR Task Force and Sub Group activities.
Follow through on priorities – Undertake activities in order to be ready to actively use RMS and OME post go-live. Follow the agreed RMS and OMS operating models post RMS and OMS go-live, which include pre-registration and ongoing maintenance of SPOR data.
Data Mapping – OMS and RMS mapping is not required by Industry prior to go-live. However, post go-live, Industry should map against new Referentials list and OMS dictionary content as it is published and synchronise their local Organisation data against these to provide a better foundation for products.
Data pre-registration – At OMS go-live Industry should send requests for new/updated Organisation data relating to MAHs only. As the dictionary is expanded with other types of Organisation data Industry will be invited to pre-register data relating to these new Organisations. Post RMS go-live Industry should send requests for new/updated Referentials prior to submitting an application.
Process change – Identify all processes that will be impacted by the changes brought about by SPOR (e.g. data synchronisation).
Systems change – Identify all impacted systems and architecture that will need to be adapted in order to support the process changes identified above.
The benefits of a harmonised approach to IDMP master data management are clear, however it will require significant effort from companies to align their internal processes with the SPOR roll-out activities.
During the preparation of the Referentials and Organisations technical services by the EMA, companies should be identifying internal processes and systems that are likely to be impacted by the harmonisation activity.
Taking advantage of the role played by the Industry Change Liaisons will allow companies to maintain a two-way dialogue with the EMA and remain informed in preparation for the transition.
2) European Medicines Agency, ‘On-boarding webinar – Industry Change Liaisons’, 21st July 2016
3) TRAC Services + Marr Consultancy, ‘IDMP – Identification of Medicinal Products’, presented 17th June 2015