The first version of the much-anticipated European Union International Organization for Standardization Identification of Medicinal Products Implementation Guide (EU ISO IDMP IG, hereafter in short EU IG) has been published. The availability of this guidance document makes now the pressing time for industry to better understand the impact of IDMP and set out activities to prepare for its implementation. In this article, the chapters of EU IG are laid out, providing a high-level summary on what is available and what measures to take to be one step closer to IDMP readiness.
The objective of the EU IG is to provide detailed guidance on the expectations on the ISO IDMP data fields within the EU regulatory framework supported by SPOR (Substances, Products, Organisations and Referentials Management Services). The European Medicines Agency (EMA) has set out to implement IDMP through a series of iterations on the four domains of the master data: Substances, Products, Organisations and Referentials (SPOR). In this first version of the EU IG, the focus is on the data requirements for the initial submission of product information, also known as iteration 1. The current version is process agnostic and does not contain information on the process for submission, exchange or validation of medicinal product information. Based on the published EU IG, companies should look into:
- SPOR data availability and mapping of the available data to internal systems
- Data requirements for Iteration 1
- Technical requirements of the SPOR Application Programming Interface (API)
- The rules governing the migration of eXtended Eudravigilance Medicinal Product Dictionary (XEVMPD) data into IDMP PMS database
Chapters of the EU IG and what to do with that information
The EU IG is outlined in 8 chapters, however currently only 4 chapters (chapter 1,2,6 and 7) are made available, as the other chapters are for now out of scope.
Chapter 1 – Registration requirement
This first chapter provides guidance on how to get access to SPOR. For any company required to submit product information to SPOR, this is an essential requirement to fulfil. Follow the instructions set out in this chapter to register for an account for your company if you have not done so yet. Completing this registration will enable your company to utilize the available service within the SPOR database, such as submitting, verifying and maintaining product information. In the meantime, it is important to make sure all the relevant Organisations and Referentials that you use are readily available and/or updated within SPOR for the initial submissions. You may also consider mapping this data from SPOR to your internal systems. In practice, as a preparation for the initial submission of medicinal products, you will need to make sure information of your own company, the Medicines Regulatory Agencies that granted you the marketing and manufacturing authorizations, and the manufacturers of the medicinal products are registered/updated in OMS. Similarly, all the vocabularies that have been used to describe this medicinal product need to be in RMS. This is to make sure that when the times comes to the initial submission, everything is ready within SPOR.
Chapter 2 – Initial submission of medicinal products
When required to submit product information, it is worth knowing what needs to be submitted. Chapter 2 outlines which data elements are required for the initial submission of medicinal products, as well as how that information should be captured in according to ISO IDMP standards. At this time, the sensible next step is to start looking into these required data. Companies need to get familiar with the IDMP data requirements and review internal sources in which data are stored and the processes in which the data is generated, used and updated. To give an example, IDMP requires comorbidity (i.e. concurrent condition) or co-infection that are included in the authorised indication(s) to be captured separately from the ‘Disease/symptoms/procedure’ aspect of the indication. What you need to do is to review how the data is currently captured (if captured at all) and how it can be captured in according to IDMP. To give you a sense of the workload, it is highly recommended to perform an estimate on the effort required to collect this data.
Chapter 3 – Maintenance (Out of Scope)
Chapter 4 – Data quality assurance (Out of Scope)
Chapter 5 – Data access/export (Out of Scope)
Chapter 6 – Technical specifications on structure and format
For industry members that wishes to integrate their local systems to SPOR, chapter 6 provides the technical specifications for the Application Programming Interface (API). The technical mechanism for product information management is a RESTful API known as the SPOR API. The recommendation is to first read the API specifications titled “SPOR API v2 Specification” to get a better understanding of the tools available.
Chapter 7 – XEVMPD – PMS Migration guide
Chapter 7 outlines the rules governing the migration and the approach to be followed by EMA for the migration of data from XEVMPD to PMS (including a back loop from PMS to XEVMPD). This chapter is provided purely for information sharing and transparency, as there is no required action for industry to implement the same approach for their own local systems. However, if you are currently looking to implement a new information management system to capture your product data, you may want to take a similar if not the same approach as EMA to migrate your XEVMPD data to the new system.
Chapter 8 – Examples (Out of Scope)
The actions recommended in this article should take your company to the next steps in getting IDMP ready. If you have any further questions, there is a possibility to raise them during our webinar on 30 March.If you are in need of any assistance in your preparation for IDMP, Iperion Life Sciences Consultancy will be happy to assist you on that. To request for more information on how we can support, contact us at email@example.com.
Author: Lunyan Zhu
Business Analyst at Iperion