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IDMP (Identification of Medicinal Product) is a set of five standards developed by the ISO to enable the unique identification of a medicinal product using a standard language across their entire lifecycle – from development to authorisation and marketing. This is ensured through the consistent documentation and terminologies to describe the medicinal product and the exchange of product information between global regulators, manufacturers, suppliers, and distributors.

The unique identification helps to improve product and patient safety for medicinal products across a range of life sciences organisations, such as CROs, biopharma companies and global regulators.

These five IDMP standards provide data elements and structures to uniquely identify and exchange information on:

  1. Substances (ISO 11238)
  2. Pharmaceutical dose forms, units of presentation, routes of administration and packaging (ISO 11239)
  3. Units of measurement (ISO 11240)
  4. Regulated pharmaceutical product information (ISO 11616)
  5. Regulated medicinal product information (ISO 11615).

Fig 1. Five ISO IDMP standards

The EMA (European Medicines Agency) is in the process of implementing these standards in a phased program based on four domains of master data. This is called SPOR.
  • Substance
  • Product
  • Organizational
  • Regulatory
These data management services help  to centralise the management of master data that complies with the ISO IDMP standards. Since July 2012, the submission and maintenance of data on authorised human medicines has already been compulsory. This has been based on a format called Extended EudraVigilance Product Report Message (xEVPRM), which will be mandatorily replaced by the ISO IDMP compatible format from 2023.

Why do we need IDMP?

Implementing the ISO IDMP standards will simplify the exchange of information between regulatory authorities and healthcare communities, thus ensuring wide interoperability. They affect every aspect of life sciences organisations from discovery to post-marketing.
  • Pharmacovigilance: The quality of data used for reporting adverse events will be improved, thereby speeding up communication, decision-making and regulatory actions;
  • Regulatory submissions: will use a consistent standard to capture and manage data, allowing information on medicinal products to be shared and re-used across different procedures and among various regulators;
  • Clinical trials: Stakeholders will access clinical trial data using well-supported standards, improving the assessment and scientific evaluation of medicines as well as communication and transparency;
  • GMP: Inspections of manufacturing sites can be streamlined, particularly for urgent situations involving defects. Faster detection of falsified medicines can also be supported as a result of these consistent data standards.

How are the documents submitted to regulatory authorities?

If the data is already present in xEVMPD system for marketed products, then this information will be migrated into the PMS (Product Management System). The product information will need to be quality controlled and enriched via an API submission to PMS prior to any submission to regulatory authorities.
According to the new IDMP submission system, when an application is made for marketing approval and for any subsequent variations via EU centralised procedure, all the unstructured data coming from different sources needs to be converted into a structured format according to the IDMP guidelines. This structured data is then submitted to the regulatory authorities through an interactive web form. This form generates a human readable PDF rendition as well as a machine-readable FHIR rendition (Fast Healthcare Interoperability Resources), which will be attached to the working documents folder of the application form (eCTD) sent to the regulatory authorities.
Marketing Authorisation Holders (MAHs) need to ensure their Regulatory Information Management (RIM) system is up to date at all times as most of the data for submission comes through this system.

What is the impact for Marketing Authorisation Holders (MAHs)?

MAHs need to check their IDMP readiness.
  • As maintaining structured data is a crucial part of IDMP, data governance forms an important step in the IDMP adoption process. All the sources of data should be identified and compliance with IDMP needs to be checked.
  • The technology that helps in mining, collection, cleansing and enrichment of data should be studied. RIM system should be adapted to accommodate the IDMP changes. Product Lifecycle Management Systems, Master Data Management systems, Data Lakes and Enterprise Architectures are some of the areas that need to be adapted to IDMP.
  • All the business processes that are impacted due to these changes should be studied and an initial gap analysis needs to be done. All the focus areas that need to be concentrated on for the next steps should be identified. In certain areas, a change may be required in the business process to maintain and capture relevant data as per IDMP standards.
  • Leaders, sponsors and stakeholders should be aligned for the change. Communications should be made with the employees regarding the changes and training should be given to support them.

References: 1.  2.


IDMP ensures consistent documentation and terminologies to describe the medicinal product and the exchange of product information between global regulators, manufacturers, suppliers, and distributors.

Here at Helixr, we work with our partners to ensure compliance through their product lifecycles. Over the coming months, we will be issuing further guidance as well as developing tools to assist with the preparation for IDMP compliance. Watch this space!

Our experts

To speak to one of our experts and find out more about this topic and how Helixr can help your business, please get in touch via our Contact form. 

Manju Sabnivisu

Scientific advisor

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HELIXR is a business restructuring and ERP services consultancy, based in the UK, with a global reach, expertise and experience that focuses on the Life Sciences sector.

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