Substance and product data management services (2024)

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 SMSbuild 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 theSMS, 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 allowsEMA 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 endorsedas 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 referentialdata 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.

Thetarget 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 activitiesin order to ensure data quality and consistency across the PMS, national data systems and pharmaceutical companies’ data systems.

EMA'selectronic application forms (eAF)facilitate capturing data for regulatory processes.EMA is updating the electronic application formsto 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 formsby 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 theTOM technical components, EMA has to implement changes iteratively, in several steps. As a result,transition periods whenmultiple 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 57data 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:

• Make ISO IDMP-compatible product data available on allauthorised medicinal products in the EU, including both centrally authorised productsand non-centrally authorised products. This will result from a data migration and continuous updates from the EMA database (SIAMED) and the xEVMPD (Article 57) database tothe PMS following the ISO IDMP standards;
• Enable pharmaceutical companies to correct and complete PMS product data;
• Enable data approved within a regulatory application to be stored in the PMS;
• Ensure adequate data quality in thePMSso that it can be confidently reused across procedures.

Marketing authorisationholders 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:

• Data submission on authorised medicines (Article 57)

Marketing authorisation holders and national competent authorities should:

• align their systems with the released terminologies for referentials, organisation and substance data;
• request the registration of any new or missing controlled vocabulary required for the submission of medicinal product data;
• start structuring their product data according to the rules described in chapter 2 of the EU IG.

EMA and the European medicines regulatory network agreed toa phased implementation:

• Product data preparatory phase
• PMS implementation - step 1
• PMS implementation - step 2

The product data preparatory phase focuses on gettingthe 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:

• whether it is still relevant tofollow a two-step approach (CAP & Fast Healthcare Interoperability Resources (FHIR)message first; non-CAPs second) and how this impacts the processdescribed inthe EU Implementation Guide’s (EU IG) chapter 3;
• whether replacingthe Art 57 data submission format,the eXtended EudraVigilance Product Report Message (XEVPRM) format, with the new ISO IDMP compatible format (HL7 FHIR) takes place only afterall relevant application forms are released by the Digital Application Dataset Integration (DADI) project.

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 exchangingmedicinal product data in the EU.

Its purpose is to enable stakeholders to prepare for the implementation of ISO IDMP standards in EU.

It providesinformation on the following:

• Timelines
• Requirements
• Process
• Technical specification
• Data elements
• Associated business rules

EMA last updated EU IDMP Implementation Guide (EU IG) in January2023.

Click on the guidanceupdate history below to find out more about the changes introduced by this and previous updates.

Applicants can start applying therules 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, EMAwill release further updates to the guide.

The EU IG is composed of the chapters below.

As of January 2023, EMA hostsand maintainsthe 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:

• providing insight on the characteristics of a substance;
• supporting assessors in the areas of quality, safety and pharmacovigilance;
• helping introduce a structured data approach for regulatory submissions.

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.