Introduction
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:
- Substances (ISO 11238)
- Pharmaceutical dose forms, units of presentation, routes of administration and packaging (ISO 11239)
- Units of measurement (ISO 11240)
- Regulated pharmaceutical product information (ISO 11616)
- Regulated medicinal product information (ISO 11615).
Fig 1. Five ISO IDMP standards
- Substance
- Product
- Organizational
- Regulatory
Why do we need IDMP?
- 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?
What is the impact for Marketing Authorisation Holders (MAHs)?
- 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. www.ema.europe.eu 2. www.calyx.ai
Conclusion
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!
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