Current Background in the EU
The IDMP (Identification of Medicinal Products) is a general term by which the 5 ISO data standards are referenced: ISO 11615 (regulated medicinal product information), ISO 11616 (regulated pharmaceutical product information), ISO 11238 (substances), ISO 11239 (pharmaceutical dose forms, units of presentation, routes of administration and packaging) and ISO 11240 (units of measurement).1 – which are being refined and implemented by regulatory bodies in support of improving pharmacovigilance via the soon-to-be mandatory submission of this data to health authorities.
[ngg src=”galleries” ids=”5″ display=”basic_thumbnail” override_thumbnail_settings=”1″ thumbnail_width=”850″ thumbnail_height=”850″ thumbnail_crop=”0″]To facilitate the phased implementation of the IDMP standards the EMA and the EU Regulatory Network have founded an EU IDMP/SPOR Task Force which comprises of participants for both Human and Veterinary medicinal products from the European Medicines Agency (EMA), Member States, experts nominated by European Pharmaceutical Industry Associations, Software Vendors and interested parties. The task force will be 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.2
The goal of SPOR is to deliver services that will centralize the management of pharmaceutical and regulatory data for Substances, Products, Organizations, and Referential (SPOR master data) and enable a consistent basis for reuse by EMA, NCAs and MAHs. Benefits of SPOR data are expected to be realized incrementally as all phases of SPOR are delivered and data is used by different business processes.
Currently, two out of four SPOR services are implemented by the EMA – the Organizations Management Services (OMS) and Referentials Management Service (RMS). The OMS and RMS are already integrated with Electronic Application Forms (eAF) and supplying organization / referential master data to MAA Human, MAA Vet, Renewal and Variation application forms. Furthermore, the EudraVigilance user registration process also started to make use of organization master data. In future OMS data is expected to support regulatory submissions in Telematics systems such as the Common European Submission Portal (CESP), CT portal and Art.57/xEVMPD.3, 4
Steps in the Right Direction
A significant step forward in the IDPM implementation process was made after the last IDMP/SPOR Task force meeting where the EU Implementation Guide (IG) draft version 1 was introduced. The EU IG is composed of an introduction and eight chapters. Brief descriptions for each chapter were presented and drafts of 4 chapters were presented as a part of version 1 of the IG with the remaining 4 chapters marked as currently out of the scope of the EU IG version 1. 5
However, these drafts were not made available for public consultation. And even if they were, it would not yet be possible to base any future business rules on the draft IG, which is currently mainly focused on technical specifications, data elements and access rights and not on how to actually submit and manage the data. And most likely it will remain as such until the Target Operating Model (TOM) and the Application Programming Interface (API) are finalized. Therefore, it’s safe to say that there is a lot of work in front of the IDMP/SPOR Task force and that there’s much to look forward to.
What’s to Come
When all phases of SPOR will be implemented, and the SPOR master data will be integrated, it will inevitably take up an important place within the business processes of the pharmaceutical industry. The EMA, Member States and dedicated Expert Groups are doing their best to make this happen.
With the deadline for IDMP/SPOR Task Force comments on the version 1 of the EU Implementation Guide already passed in April, the second half of 2019 promises a second consultation on the EU IG within the IDMP/SPOR TF and the final EU IG is planned to be published in 2020.6 Hopefully, a draft for public consultation will be provided within this timeframe providing the industry with enough time to adapt with the already rapidly changing legislative environment.
Even though the IDMP standard implementation will definitely result in a requirement to collect and manage a wider array of data resulting in an increased administrative burden, it’s best to look at this inevitable change as an opportunity to revise the data collection and management processes within a company and to optimize these processes up to a point where it is possible to comfortably collect the various data elements from multiple sources within different departments and affiliates of your company.
To get more information about the ISO IDMP standards implementation process, contact us!
Gediminas Zvicevicius MPharm
Lead Pharmacovigilance Specialist
- European Medicines Agency. Data on medicines (ISO IDMP standards): Overview.
- EMA Information Management. Task Force for the implementation of International Standards on Identification of Medicinal Products in the EU (i.e. EU IDMP/SPOR Task Force). EMA/111947/2015. 1 September 2016.
- EMA Information Management Division. Referentials Management Services (RMS) operating model. EMA/412376/2016 version 2. 25 May 2018.
- EMA Information Management Division. Organisation Management Services (OMS) operating model. EMA/459105/2016 version 6. 30 April 2019.
- EMA Information Management. Minutes of the European Union (EU) International Organization for Standardization (ISO) for the identification of medicinal products (IDMP) / Substance, Product, Organisation and Referential data (SPOR) task force meeting. EMA/881990/2018. 04 December 2018.
- EMA presentation on SPOR data services – update to SPOR TF. 04 December 2018.