EU’s Status on IDMP

September 1, 2018

Applied Clinical Trials

Volume 27, Issue 9

Insights into the implementation of IDMP in the EU.

The European CRO Federation, or EUCROF, recently posted Pharmacovigilance in 2020: Boldly Shaping the Future, an overview, Part 2: Identification of Medicinal Products (IDMP) Implementation (https://www.eucrof.eu/images/Documents/18-08-17-idmp-implementation_eucrof_pv_wg.pdf) developed by its Pharmacovigilance Working Group.

This paper follows another released last year, that offered insight into the increasing challenges of pharmacovigilance (PV) in the European Union (https://bit.ly/2MUDAlc). This paper addresses the worldwide effort of IDMP to harmonize medicinal product specifications across regulators and industry, and covers the whole lifecycle of a product from the lab onwards. Because the EU is the first region in the world to start implementing IDMP, this paper offers insights into the current state of IDMP in that region.

The authors first offer the explanation of IDMP as “the set of five ISO standards that are based on the HL7 standards for data elements, formats, and terminologies to uniquely identify and exchange information on medicines. Each standard describes different distinct elements of a pharmaceutical product.” They offer a definition for each elements, as well as a helpful schematic to understand those elements.

The reason the IDMP falls under the PV domain is that it began as a tool to improve their safety activities, but the authors maintain that the scope has widened based on additional benefits expected with internationally harmonized IDMP adoption. Those benefits include, but are not limited to:

• Facilitating the identification and exchange of product and substance information globally, across regulators.

• Improving data integrity and reliability.

• Enabling reuse of data across different procedures and regulators.

• Faster product identification in case of withdrawal of products with the same active substance.

• Quicker and more efficient response to findings on manufacturing sites that have impact on the quality of products.

• Minimize incidences of repeat information submission to authorities in the context of regulatory applications.

The European Medicines Agency’s (EMA) approach to implementing the ISO IDMP standards is based on four domains of master data in pharmaceutical regulatory processes: Substance, Product, Organization and Referential data (SPOR). Although there is no direct mapping between the four SPOR domains and the five IDMP ISO standards, SPOR data elements will cover all requirements of IDMP. The authors describe the four domains in the paper, as well as industry’s role in regard to the four domains.

While the EMA has issued its intentions around IDMP, industry is not without its duties, as just mentioned. For example, “all the data available to an organization that are associated with medicinal products should be identified, restructured, organized, and finally streamlined with the standard definitions, as they become available/published.” The working group authors lay out a series of general steps that companies should follow in order to implement IDMP, noting that “a key element for a successful IDMP project is a comprehensive data source identification.”

As far as timing for global implementation, in the EU, submissions of IDMP data will become mandatory most likely by the end of 2018 or beginning 2019.

 

-The EUCROF Pharmacovigilance Working Group.

 

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