This content applies to human medicines only.
The PMS and SMS will manage two of the four domains of substance, product, organisation and referentials (SPOR) master data in pharmaceutical regulatory processes. SPOR data management services will facilitate the reliable exchange of medicinal product information in a robust and consistent manner.
The SPOR services support the implementation of ISO IDMP standards in the EU / EEA.
The PMS and SMS build on the data foundations of theReferentials Management Service (RMS) andOrganisations Management Service (OMS), which EMA launched in June 2017.
The PMS and SMS implementation process is iterative, in steps. The first iteration covers a subset of ISO IDMP data fields. Later iterations will see the standards fully implemented in the EU.
The first iteration of the SMS, in 2019, enabled users to request the registration of a new substance term or the update of an existing substance term through EMA Service Desk. This allows EMA to manage the substance data. Future iterations of SMS will include synchronising SMS with the European substance reference system (EU-SRS) database and delivering an SMS user interface.
The first iteration of the PMS will cover a subset of the authorised medicinal product part of the ISO IDMP standards. As part of this iteration, the new ISO IDMP compatible data submission format (HL7 FHIR) replaces the current data submission format, the eXtended EudraVigilance Product Report Message (XEVPRM).
Future PMS iterations will implement other product data elements of the authorised medicinal product and the investigational medicinal product part of the ISO IDMP standards.
The draft international messaging standard known as Fast Healthcare Interoperability Resources (FHIR, pronounced “fire”) was endorsed as the basis for the application programming interface (API) for PMS.
FHIR will be the data standard that supports the exchange of information about medicinal products, substances, and related referential data in the European medicines regulatory network.
EMA, the United States Food and Drug Administration (FDA) and the European medicines regulatory network are working with Health Level Seven (HL7) to incorporate the ISO IDMP standards into the FHIR specification.
The target operating model (TOM) shows how product data can be re-used in regulatory processes and applications.
EMA is working to ensure that the technical components and business processes align with regulatory activities in order to ensure data quality and consistency across the PMS, national data systems and pharmaceutical companies’ data systems.
EMA's electronic application forms (eAF) facilitate capturing data for regulatory processes. EMA is updating the electronic application forms to improve the process of entering product data.
Pre-existing authorised product data is retrievable from the PMS database (1).
The relevant medicine regulatory authority assesses and manages the data submitted in the dossier (and application form). Standardised product data facilitates this process (2).
Product data and relevant documents are stored and made available from the PMS. Once fully implemented, PMS data and documentation will fulfil the legal requirements of Article 57 of Regulation 726/2004 (3).
Authorised product data and documents stored in the PMS can be re-used in the further regulatory activities between regulators and pharmaceutical companies.
In 2022, EMA is focussing on replacing the current pdf-based electronic applications forms by web-based forms as part of implementing the TOM.
The first form to be replaced is the variation eAF. Forms supporting other regulatory procedures, such as the initial marketing authorisation, will follow.
The PMS is supporting implementation of the electronic forms by making ISO IDMP-compatible product data available on centrally authorised products (CAPs) and non-centrally authorised products (non-CAPs).
It is also improving the technical components needed to reflect authorised data in the PMS.
Due to the complexity of developing and implementing a data-centric business process that is aligned with regulatory activities and the TOM technical components, EMA has to implement changes iteratively, in several steps. As a result, transition periods when multiple systems are being used in parallel are unavoidable, even though this is inconvenient for regulators and applicants.
EMA is in the process of updating the three-year portfolio objectives as input for the portfolio roadmap. This includes the prioritisation of the ISO IDMP implementation roadmap, including replacing the Article 57 data submission format. EMA is carrying out these activities following an agile approach. It is working closely with industry stakeholders and its partners in the European medicines regulatory network to align strategic priorities and ensure that the portfolio reflects the needs of all stakeholders.
In 2022, EMA excepts to progress the following activities:
Marketing authorisation holders must continue to submit data on authorised medicines in the XEVPRM format in order to comply with their regulatory obligations under Article 57 of Regulation 726/2004.
For more information, see:
Marketing authorisation holders and national competent authorities should:
EMA and the European medicines regulatory network agreed to a phased implementation:
The product data preparatory phase focuses on getting the target operating model ready. This phase began with the launch of the RMS and the OMS in 2017 and continues throughout 2022 (see PMS contribution to TOM in 2022 above).
EMA is still deciding some aspects of the implementation. These include:
EMA recommends that applicants monitor the EMA website as well as the eSubmission website for updates and announcements.
The EU IDMP Implementation Guide (EU IG) for the submission of data on medicinal products defines the implementation requirements of the ISO IDMPstandards for the EU. The EU IG is the basis for submitting and exchanging medicinal product data in the EU.
Its purpose is to enable stakeholders to prepare for the implementation of ISO IDMP standards in EU.
It provides information on the following:
EMA last updated EU IDMP Implementation Guide (EU IG) in January 2023.
Click on the guidance update history below to find out more about the changes introduced by this and previous updates.
| DATE | GUIDANCE ADDED |
|---|---|
| July 2022 |
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| June 2021 |
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| February 2020 |
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Applicants can start applying the rules in the latest update to structure their product data. This enables them to complete and correct any product data as necessary before the use of the electronic application forms becomes mandatory at the end of a transition period.
During 2023, EMA will release further updates to the guide.
The EU IG is composed of the chapters below.
EMA will update Chapter 3 in due course to capture the impact of the new web-based forms in the data submission process.
This chapter is scheduled for inclusion in subsequent releases of the EU IG.
This chapter is unchanged since the first release of EU IG.
EU IG v2.0 and further minor releases, including EU IG v2.1 and EU IG v2.1.1, mainly support the implementation of PMS Step 1 and data submission on medicinal products authorised through the centralised procedure.
They provide:
This information enables the European medicines regulatory network to prepare for the submission of data on all medicinal products for human use authorised in the EU. It offers a basis for practical preparation activities, such as:
Close collaboration between all stakeholders is crucal in these preparation activities, including industry, software vendors and regulators.
The European medicines regulatory network has agreed a phased release plan for the EU Implementation Guide. EMA is releasing several versions to reflect the details of the latest agreements available and enhance quality.
To minimise the impact on implementation, EU IG v2.1 focuses on enhancing data-related aspects to provide visibility of data elements, business rules, data transformation and required data collection, whereas EU IG v2.2 will focus mostly on process clarifications for the electronic submission of authorised medicinal product data in PMS.
EU IG v2.1 contains minor updates to the data elements that should be reported to PMS, further details on the RMS lists that are needed and more examples. EU IG v2.1 also contains new data elements that required to support the PMS target operating model foreseen in PMS Step 2. These new data elements are part of ISO IDMP standards, have optional or conditional submission and address future integration with eAFs and reporting on marketing status to support the handling medicine shortages.
EU IG v2.1.1. provides:
Although the data fields and specifications presented in EU IG v2.1.1 should remain stable, some business rules may be subject to minor modifications in future releases of the guide.
While no substantial changes are expected to the submission process, further details may be added, in version 2.2, particularly with regards to data migration and enrichment of data.
EMA will publish more chapters as part of the guide's next major release, EU IG v3, to help the European medicines regulatory network prepare for Step 2, the last step of product data implementation.
The specification of the SPOR API reflected in Chapter 6 is subject to development and testing. As with any software, it may evolve over time and will be subject to change control.
Both this guide and the API can be expected to evolve with understanding of business processes and requirements and application of technological improvements, although no significant changes are expected.
As of January 2023, EMA hosts and maintains the EU Substance Registration System(EU-SRS) that gathers scientifically sound data on substances used in medicines.
These data include defining characteristics of substances, molecular structures, and amino acid sequences and relationships.
The EU-SRS covers a variety of use cases, such as:
The Substances Validation Group maintains the actual substance data. This group brings together experts from national competent authorities in EU countries.
The German Federal Institute for Drugs and Medical Devices (BfArM) previously maintained the EU-SRS.