IDMP Advisory Update: The latest on DADI-based EMA submissions

by The fme Team |
Mar 29, 2023 |

The Identification of Medicinal Products (IDMP) is a set of global standards for the identification and description of medicinal products developed by the International Organization for Standardization (ISO). It facilitates information exchange between regulatory authorities, pharmaceutical companies, and other stakeholders in the healthcare industry to improve patient safety.

The official launch date for the standard has not been defined, and the expected dates have shifted several times in the past years. The short guide below recaps the latest advice on important milestones and deadlines, and offers a useful action plan as companies strive to make their data-first regulatory initiatives count – both now and for the longer term.

“This information was reviewed and valid in Q4-2022. Due to EMA’s agile development approach there may be additional updates or changes. Please contact us to discuss how the most recent changes impact you.”

IDMP in Europe and the US

The European Medicines Agency (EMA) has mandated the use of IDMP for pharmaceutical companies operating in the European Union (EU) by 1 July 2022. That date has been revised, and as of this writing an official launch date has not been defined–the expected dates have also shifted several times. This has relieved some of the immediate pressure on pharmaceutical companies adapting existing systems and data as it takes a significant investment of time and resources to implement the standard.

The US Food and Drug Administration (FDA) has proposed the use of IDMP, but implementation dates are yet to be determined. fme recommends that all pharmaceutical companies across the globe be prepared to comply with the IDMP standard as it continues to increase in acceptance.

In this paper

After the most recent updates to EMA requirements, fme put together a summary and handy action plan to help guide Life Sciences companies toward the most effective and efficient system migration. In this eBook we’ve included:

• DADI Human Form Timeline
• A summary of how the latest developments could affect you
• Elements of the requirement that have not yet been defined
• 4 benefits of IDMP to exploit
• 5 things pharmaceutical companies should do next

Moving forward with IDMP

The latest guidance encourages all Life Science companies to become more data-centric in their mindsets and everyday activities to become more efficient and effective. Any foundational digital transformation work done now will ensure companies are well positioned when other regions across the world implement their own approach to IDMP.

Don’t fall behind. Download fme’s IDMP Advisory Update eBook now, and ensure that your team stays aligned with the coming requirements.


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Tracey King
Technology Success Manager