Submission of pharmacovigilance obligations of pharmaceutical industry
The pharmaceutical industry also plays an important role in ensuring the safety of medicines being accessed by the public. The obligations of the market authorization holders (MAHs) in terms of pharmacovigilance are stated and discussed in the FDA Circular No. 2020-003 Guideline for Pharmaceutical Industry on Pharmacovigilance.
It is mandatory for the MAHs to submit reports of suspected adverse reactions either using the CIOMS I form or through electronic submission in E2B format. The CIOMS I form should be submitted either through email at [email protected] or via the FDA Action Center (FDAC). The submission of reports are assigned with Document Tracking Number (DTN), which serves as the acknowledgement receipt.
There are two ways to submit individual case safety reports (ICSR) compliant with the ICH E2B format. In the early phase of implementing the E2B submission, MAHs are instructed to send the E2B xml files as an email attachment to [email protected] The xml file is imported in the VigiFlow system manually by the pharmacovigilance team. The acknowledgement log is sent through a reply to the email submission. The following details are necessary for the VigiFlow to recognized the E2B files:
E2B receiver elements
Content of data element
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As part of the continuous effort to improve reporting efficiency, national pharmacovigilance centres together with the Uppsala Monitoring Center have developed a new system of reporting – the eReporting for Industry. This eReporting for Industry tool allows MAHs to submit ICSRs securely to the FDA using their accounts. Having access to their accounts enables MAHs to upload ICSRs directly to the VigiFlow system and the acknowledgement logs are provided upon successful submission of reports. The process is more efficient for both the pharmaceutical industry and the FDA pharmacovigilance team.
If you are interested in submitting E2B xml files through the eReporting for Industry, you may send us an email at [email protected] Our team will guide you and assist in the process.
Note that all MAHs are required to be ICH-E2B compliant before the end of Year 2025.
Last updated: 11 August 2022