Understanding E2b(R3) Compliance
About E2B(R3) compliance
The development of ISO ICSR/ ICH E2B(R3) was initiated in the year 2004 considering the need for an efficient transmission of safety reports in a format that can be generated and processed nearly automatically by a transactional database. The key elements of the new E2B(R3) are Electronic Transmission of Individual Case Safety Reports (ICSRs), Data Element and Message Specification.
Benefits of E2B(R3) Compliance
- Improved ICSR format (~ 10 years of operational excellence)
- Better granularity based on additional data elements
- Alignment with new ISO Identification of Medicinal Products (IDMP) standards
- Improved quality of reports
- Interoperability with healthcare system e.g. electronic health records
- Acceptance beyond ICH regions improving harmonization of data formats
Key differences between E2B(R2) and E2B(R3)
- Change in data structure
- Numbering of data elements
- Improved user guidelines
- Use of Object Identifiers and Null Flavors
Why 4C ?
As we all know that E2B(R2) lacked harmonization in medicinal product information and medicinal product terminology (IDMP), E2B(R3) was brought in as the gold standard.
In order to implement E2B(R3), the pharmaceutical companies will need to upgrade drug safety database or the drug safety vendors will have to redesign their database structure and adhere to E2B(R3) guidelines. Creating an E2B(R3) compatible database itself is not sufficient; the system should be able to convert ICSR and ICSR ACK message back and forth between E2B(R2) and E2B(R3) formats. In other words, the system should have Backwards and Forwards Compatibility (BFC).
Although the revision of E2B(R3) was initiated by EMA in 2004, EMA now has decided to make it mandatory by 22nd of November 2017, therefore making it very crucial for Pharma companies to adopt the change. The cost of upgrading to newer systems and data migration can be tedious and expensive, but not necessarily with us.
4C is a comprehensive healthcare solutions provider company, specializing in Pharmacovigilance, Medical Information Call Center, Regulatory Affairs, Medical Writing, Clinical Data Management and Hosting Solutions