IDMP Implementation with the SAP Life Sciences Cloud Polaris at Klosterfrau

KEY DATA:

• Project objective: Digitisation of IDMP data and other product data
• Initial situation: Mainly manual management of marketing authorisation data in Excel
• Scope: Approximately 270 marketing authorisations
• Software solution: SAP Industry Cloud solution Polaris from Gramont
• Technology: Cloud application on the SAP Business Technology Platform
• Consulting Partner: DHC Dr Herterich & Consultants GmbH
• ERP system: SAP S/4HANA
• Release cycle: biannual major releases with new functionality, monthly updates with product enhancements
• Validation: Fully validated system according to Klosterfrau’s guidelines with change management for monthly releasesProject goal: Digitalisation of IDMP data and further product data

European Medicines Agency = EMA

The EU is making great efforts to harmonise standards. One area of harmonisation is the Identification of Medicinal Products (IDMP) in the European market. The purpose of IDMP is to ensure interoperability of product data in a data flow where all stakeholders can rely on the same dataset for regulatory, pharmacovigilance and supply chain processes. The reporting of IDMP data will replace the existing XEVMPD procedure. The EMA has developed 4 SPOR services for this purpose:

• Substance Management Services (SMS) – productive from 2019
  Harmonised data and definitions to uniquely identify the
  ingredients and substances of medicinal products
• Product Management Services (PMS) – read-only in Q2 2024, write end of 2024 / early 2025
  Harmonised data and definitions for the unique identification
  of medicinal products based on defined information (e.g.
  marketing authorisation, packaging and product information)
• Organisations Management Services (OMS) – productive since 2017
  Data that includes the name and location of organisations such as Marketing Authorisation Holders (MAH), sponsors, regulatory authorities, manufacturers
• Referentials Management Services (RMS) – productive
  since 2017
  List of terms (controlled vocabulary) used to describe characteristics of products, e.g. list of dosage forms, units of measurement, routes of administration

The EMA has published an implementation guide for the PMS which, among other things, defines the data model for the IDMP data to be reported. The values from SMS, OMS and RMS will be used in the product data. As a first step, the EMA will transfer the XEVMPD and SIAMED data to the PMS. This has to be checked and completed by the pharmaceutical companies. Changed and new medicinal product data will then have to be reported directly to the PMS – either manually via a user interface or electronically via a software interface. In addition to the EU, other authorities such as the FDA and local authorities also require this information. This means that there is a global initiative to use harmonised data on an international level for various business use cases, such as clinical trials, medical use and regulatory procedures to ensure patient safety. Other authorities preparing for ISO IDMP include Health Canada, Anvisa Brazil and Swissmedic Switzerland. This will require the establishment of appropriate IT systems and processes within the company.

SAP and Gramont’s Polaris cloud application 

To support these tasks, SAP offers Gramont’s Polaris cloud application in its Life Sciences Industry Cloud. Polaris is an SAP cloud application that integrates with SAP S/4HANA and SAP ECC to consolidate structured and unstructured data for use in the electronic submission of marketing authorisation dossiers. It enables the integration, aggregation and standardisation of this data and its transformation into ISO IDMP standards,
terminology and formats. It offers a flexible architecture to help companies meet additional requirements as they arise. The IDMP SAP Cloud Application Polaris provides the following capabilities:

• Management of product information for medicinal products
  and medical devices
• Regulatory content preparation, submission and tracking
  of market authorisation
• Management of structured and unstructured data
• Controlled vocabulary management
• Product change planning, tracking and integration
• Integrated data quality and data consistency checks
• A flexible framework that supports current and future data
  exchange processes with regulatory authoritiesworldwide

Polaris is an integrated extension to the SAP ECC and S/4HANA products and is SAP’s standard method for managing this part of the business process for submission/registration of product data. Technically, Polaris runs on the SAP Business Technology Platform.

KLOSTERFRAU

Klosterfrau has 1,700 employees and sells more than 220 products both nationally and internationally. SAP S/4HANA is used as the ERP system. COI’s PharmaSuite software is used for the management of regulatory data, publishing and the management and reporting of EVMPD data. Klosterfrau evaluated the software market in a selection process for IDMP software. The decision was then made to develop a new IDMP-compliant product database as an SAP cloud application from SAP software partner Gramont. A key factor in the decision was integration with the existing SAP S/4HANA system, providing a technical basis for harmonising master data. The implementation and further development took place as part of a co-innovation with Gramont.

THE SOLUTION

The SAP Industry Cloud solution Polaris has been implemented at Klosterfrau to manage IDMP and other Klosterfrau-specific approval data. For integration with SAP S/4HANA, an interface to the material master and business partners (for manufacturers) is available. This enables harmonisation with the central SAP ERP master data. The IDMP data is captured, approved and released in Polaris. The data model conforms to the specifications of the EMA Implementation Guide and is continuously adapted to changes. In Polaris, it comprises a total of 7 data types:

• Marketing Authorisation:
  Contains the description of the marketing authorisation for a medicinal product.
• Medicinal Product:
  All authorised products within the scope of Article 57(2) of Regulation (EC) No 726/2004
• Packaged Medicinal Product:
  Information relating to the packaging/containers of a medicinal product and all associated medical devices.
• Manufactured Items:
  A medicinal product may contain one or more items. In many cases, the manufactured item corresponds to the pharmaceutical product.
• Medical Device:
  Medical devices that are marketed in combination with the medicinal product (e.g. measuring cups).
• Pharmaceutical Product:
  The “pharmaceutical product” data record describes the qualitative and quantitative composition of a pharmaceutical product in the pharmaceutical form authorised for administration to the patient in accordance with the prescribed product information.
• Substances:
  Information on the ingredients of a manufactured product and the pharmaceutical product.
• Manufacturer Information:
  Information on the manufacturer of the medicinal product.

When the data is saved, it is checked for accuracy. Data from SMS, OMS and RMS is always entered via selection fields to ensure that it matches the SPOR database. A workflow controls the approval and release of records by other staff. In addition to the input function, the comprehensive query of the product database is an important function. For example, it is possible to search for all products containing a certain substance from a certain manufacturer.
The data is initially stored as a company record (with the status in process, released). Once the interface to the PMS has been finalised by the EMA, the functionality to transfer the data to an agency record and electronic reporting to the EMA Product Management Service will be introduced.

THE PROJECT

After an extensive proof of concept together with SAP and DHC Dr. Herterich & Consultants GmbH, Klosterfrau’s RA and IT departments decided to implement the SAP IDMP Cloud solution. A project team consisting of RA, IT and validation specialists as well as DHC consultants and the Polaris product owner from Gramont was set up. A steering committee with stakeholders from IT, RA, DHC and Gramont supported the project from the beginning. As the system was classified as GxP critical, the implementation was carried out in accordance with Klosterfrau’s validation guidelines. A Polaris system landscape was provided from the start of the project. Initially, a development system was used to set up the sample IDMP data, then a test system for validation and finally a production system. User requirements were defined and subjected to a risk analysis. In addition to the IDMP objects, further information had to be collected for the complete digitisation of the regulatory data. The implementation was then described in functional specifications. At the same time, the data sources for the IDMP data within Klosterfrau were identified. To illustrate the transition to a digital platform, the IDMP data for selected products were collected in the development system as an example from the outset. This allowed the RA department to gain an early understanding of digitisation, but also to test the Polaris functions throughout the project. For software validation, the complete IDMP data set for 20 products was collected and stored in the Polaris test system. With this test data and extensive test plans, all system functions were finally validated and the production system was released. The next step is to build and release data for 270 product authorisations in the Polaris production system. In parallel, the EMA is working on the release of the API (Application Programming Interface) for its PMS. Once this is available, the IDMP data transfer of the marketing authorisations will be done electronically via Polaris.

«I had the opportunity to work with experienced and inspired colleagues as well as very competent and committed partners at DHC and Gramont. … Together we have created something completely new and innovative».
Ulrike Werdün
Project Manager at Klosterfrau

Contact Germany

DHC GmbH | Matthias Bothe
Landwehrplatz 6-7 | D – 66111 Saarbrücken
P +49 681 93666-0
matthias.bothe@dhc-gmbh.com