How does E2B improve stakeholders access to ICSR data electronically?
The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) has published a short training video on the electronic transmission of ICSRs in E2B (R3) format. This video explains why this format was developed, and its advantages in the exchange of pharmacovigilance data between different stakeholders worldwide.
Individual Key Safety Reports (ICSRs) have a significant role in the regulation of pharmaceutical products and the communication of adverse events worldwide. With the rise of globalisation and new drug discoveries, many stakeholders around the world need to communicate or receive this information quickly and efficiently.
Processing large volumes of safety information and communicating it to other stakeholders can be complex and difficult. Thus, in order to make data transmission easy and efficient, the E2Bs guidelines standardise the formats for storing and transmitting digital data, so that, regardless of the source and destination, the database can be transmitted directly without conversion or re-entry, allowing for better signal detection.
This enhances the stakeholder’s ability to:
- Collect and analyse safety reports
- Review safety reports more quickly
- Identify and assess emerging safety issues
- Disseminate safety information in support of public health missions
- Reduce costs by enabling easy aggregation of safety data for analysis and minimizing the resources necessary for data entry.
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