In this blog, we explore:
- The definition and significance of “E2B”
- The role that E2B plays in the field of pharmacovigilance.
Table of Contents:
- An Overview of E2B and Its Meaning
- Initial Implementation of E2B
- The Need for Safety Information Exchange
- Role of E2B
- E2B Compliant File Format
- Key takeaways
- Conclusion
- Abbreviation
- References
- FAQ
What is E2B?
In pharmacovigilance, E2B refers to the “Electronic Transmission of Individual Case Safety Reports (ICSRs).” This term does not have a fixed translation and can understand in various ways within the business context.
The closest and most appropriate translation for E2B is “Electronics to Business.“
Initial Implementation of E2B
This is first standard electronic format developed in regulatory submission. The first automation takes place electronically to improve its efficiency and consistency and data accuracy in the standardised format.
According to the International Conference on Harmonization (ICH), E2B is referring as “Efficacy Topics Data Elements for Transmission of Adverse Drug Reactions Reports (ICH).”
📢 Click here to explore more in details and nuances of ICH Guildeines.
Under the ICH guidelines, E2B is an international standard used for transmitting medical information about adverse events from pharmaceutical companies to regulatory authorities and other stakeholders in the healthcare industry.
“Embrace the power of E2B – Effort to Benefit – for it is in our willingness to invest effort that we unlock the true potential of success and growth.”
Maintenance and Evolution
E2B (R3) represents the current standard format for the electronic exchange of pharmacovigilance data related to adverse drug reactions. This format based on the international standard known as HL7.
📢 If you’d like to learn more, click here to explore the significance of HL7 and standardization in pharmacovigilance.
The standardization process initially introduced and upheld by the International Conference on Harmonization (ICH).
Yet, it has evolved over time to involve a collaborative effort between ISO and regulatory bodies to maintain this tool.
The Need for Safety Information Exchange: Who, What, and Why
Due to national and international agreements, regulations, and the imperative to safeguard patient safety, expediting the exchange of safety information (e.g., ICSRs) is essential:
- Between identified reporting sources and regulatory authorities as well as pharmaceutical companies;
- Among regulatory authorities;
- Between pharmaceutical companies and regulatory authorities;
- Among pharmaceutical companies;
- From clinical investigators, facilitated by the clinical trial sponsor, to ethics committees; or
- From authorities to the World Health Organization (WHO) Collaborating Centers for International Drug Monitoring.
Role of E2B
- E2B is primarily utilising for electronically submitting Individual Case Safety Reports (ICSRs).
- It established a structured and consistent format for reporting and exchanging information like suspected ADR, medication errors, and other drug safety data.
- The implementation of the E2B format has facilitated the transition from handwritten reports to fully electronic submissions.
- It ensures that the information is consistently organized, enabling regulatory authorities and other recipients to comprehend and analyze the data.
- E2B has undergone many revisions aimed at improving data quality, enhancing safety analysis, and incorporating advancements in information technology. The latest version, E2B(R3), introduced with significant changes, like MedDRA, and the inclusion of extra data elements.
Overall, E2B plays a crucial role in facilitating the timely and standardized exchange of pharmacovigilance data, enabling better monitoring and evaluation of drug safety profiles and contributing to patient safety.
Advantages of electronic transmission
The ICH ICSR enhances electronic adverse event reporting and analysis by facilitating the efficient reporting of suspected product-related adverse events/reactions. The electronic environment:
- improves the ability to efficiently exchange and process ICSR data;
- facilitates the transfer of information to organisations who need it;
- enables incoming messages to be automatically routed and processed;
- facilitates aggregation of safety data for analysis; and
- allows minimising resources required for data (re-)entry activities.
E2B Compliant File Format
Initially, safety information exchange predominantly relied on paper-based formats such as Yellow Cards, CIOMS I forms, and MedWatch forms, alongside electronic media formats like online access, tape, and CDs.
With the exponential increase in the accumulation of cases worldwide, there emerged a pressing need for faster and more efficient electronic transmission. Consequently, the transition to electronic database-to-database exchange became imperative and continues to evolve.
To electronically submit Individual Case Safety Reports (ICSRs), manufacturers must possess the capability to transmit E2B or E2BM [[SGML File|compliant SGML DTD data files]], as specified by the International Conference on Harmonization (ICH). Detailed guidelines for preparing such files can be accessed at the ICH-M2 ESTRI Guidelines.
However, in spite of this fact, the SGML-based DTD (Document Type Definition) approach is no longer the optimal solution. As a result, the current messaging standard herein now relies upon XML schemas.
Key takeaways
- E2B transmission is specifically designed for transmitting Individual Case Safety Reports (ICSRs).
- E2B is an electronic transmission; and prior to itsintroduction, it was handwritten and physically maintained.
- E2B is intended for rapid data transfer and has evolved through three revisions to date.
- The initial consideration, facilitation, and introduction of E2B were spearheaded by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), now accompanied by regulatory authorities and pharmaceutical representatives.
Conclusion
This article focuses solely on E2B and its significance. It aims to help you gain clarity on any long-standing questions you may have had about it.
There have been several revisions to E2B, with the latest being E2B(R3). We have a section specifically discussing the revisions of E2B which you can explore if interested.
Feel free to comment if you’d like to delve into any specific topics within pharmacovigilance.
Abbreviations:
- ICH – International Conference on Harmonization
- MedDRA – Medical Dictionary for Regulatory Activities
- ADR – Adverse Drug Reactions
- ICSR – Individual Case Safety Reports
- SGML – Standard Generalized Markup Language
References:
FAQ:
What is E2B in pharmacovigilance?
Role of E2B in pharmacovigilance
2. It is a structured and consistent format for reporting and exchanging information.
3. It ensures that the information is consistently organized, enabling regulatory authorities.
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