Since 2010, European Union (EU) Pharmacovigilance legislation is subject to regular and further enhancements because of EudraVigilance (EV), particularly the collection, management, and analysis of suspected adverse reaction reports. This includes the implementation and use of new ISO Individual Case Safety Report (ICSR)/ICH E2B(R3) standards, which deliver better data structures including quality, as well as interoperability with other healthcare systems.
This new EU EudraVigilance guidance specifies the technical requirements and the process of transmission of Individual Case Safety Reports (ICSRs). It is applicable to all stakeholders, which are exchanging ICSRs electronically within the EEA. These technical requirements are an evolution of the ICH E2B(R2) to make reporting more useful and compliant with the new pharmacovigilance (PV) practices.
IDMP: Key Role
The key changes to electronic reporting requirements are:
- Usage of ISO standards in the reporting of ICSRs, ISO ICSR standard 27953-2:2011.
- Usage of ISO IDMP terminologies in the submission of ISO ICSR messages.
Therefore, the synergies between the EudraVigilance and ISO IDMP become essential for the implementation of these new EV systems (see graphic below). That is why the European Medicines Agency (EMA) integrated the future use of the ISO IDMP standards in the context of the new ICH E2B(R3) format. This is elaborated in the EU ICSR Implementation Guide (EMA/51938/2013) and includes the following data elements:
- Medicinal Product Identifier (MPID) (ISO 11615): To define, characterize, and uniquely identify regulated medicinal products during their entire life cycle.
- Pharmaceutical Product Identifier (PhPID) (ISO 11616): Based on the subset of elements that describe the pharmaceutical product. This is the next level of precision down from MPID.
- Product Name Parts: Following the ISO model structure.
- Substance/Specified Substance Identifier (ISO 11238): ID to be used if the two identifiers mentioned above do not exist.
When reporting an adverse event, these IDMP IDs will be referenced in ICSR.
IDMP and E2B(R3) Data Exchange
Additionally, comparing the ICH E2B(R3) requirements with the IDMP requirements, we conclude that a significant number of data fields are shared and will be needed for both IDMP and ICH E2B(R3). This creates additional dependencies between PV systems and IDMP data, which typically reside in regulatory databases or on other systems outside of PV.
Furthermore, standardization and integration between these two initiatives will be beneficial for the upgrade or implementation of an E2B(R3) compliant PV system:
- Product safety information will be collected globally in a common vocabulary, making it possible for data to be exchanged and analyzed on a global scale.
- By using the ISO IDMP standards, we ensure a clear identification of the concerned medicinal products and substances across regions, as well as their related adverse events.
Take Home Message
Leveraging ISO IDMP standards will improve the quality, accuracy, and value of adverse event reports. It offers clear identification of products and ensures the use of uniform, globally standardized controlled terminology, thus leading to the improvement of drug safety across regions. Considering the upcoming ISO IDMP requirements and processes while implementing a new or upgrading your PV system will be a critical success factor. It also will deliver clear synergies.
Would you like to learn more about how to take advantage of ISO IDMP for a successful ICH E2B(R3) implementation? Contact us and meet our IDMP and PV experts who will support and facilitate your company’s journey to IDMP and E2B(R3) compliance.