On June 10, 2014, the FDA issued a final ruling modifying submission requirements for Individual Case Safety Reports (ICSR). The modification requires pharmaceutical companies submit the adverse event data electronically through the FDA gateway. Previously companies had the option of electronically filing or generating the necessary documents required by the guidelines and faxing or mailing them to the FDA. This ruling takes effect June 14, 2015.
What is ICSR and this New Guidance Update?
ICSR is the pharmaceutical industry equivalent to electronic medical device recording (eMDR) in the medical device industry. Electronic submissions of eMDR’s have been required for a few years now.
The new requirement is the adverse event must be submitted by an XML file following international HL7 guidelines through the FDA electronic gateway. In a related Draft Guidance Document, FDA stated between now and the effective date they intend to implement a web portal for electronic entry of required data for small companies or those that have only a handful of ICSRs per year.
Guidance Update Implications for Pharmaceutical Companies
The impact on most pharmaceutical companies should be minimal. Companies are already responsible for reporting and tracking these potentially severe adverse events to the FDA. The difference will be felt by companies that currently supply the FDA this information in paper format through fax or mail.
The FDA’s stated goal for this change is to “help the Agency to more rapidly review postmarketing safety reports, identify emerging safety problems, and disseminate safety information in support of FDA's public health mission. In addition, the amendments will be a key element in harmonizing FDA's postmarketing safety reporting regulations with international standards for the electronic submission of safety information”.
Many Pharmaceutical companies already use quality management systems (QMS) to generate the 3500A form required for ICSR reporting. TrackWise by Sparta Systems provides automated electronic submission capabilities, so QMS can be used to meet the new electronic submission requirements. The benefit is that these submissions can be tracked, managed, audit trailed, and reported on directly from the system. When TrackWise is used to manage product complaints, a built in decision tree can determine if an ICSR is required, and will automatically kick off the process for collecting data and generating and transmitting the report in the required time frame. Companies can also relate these ICSR’s to complaint records and related CAPAs and change requests and having analytic capabilities available to quality units to investigate root causes and remediation is a powerful tool to help reduce the number of or eliminate your ICSR reports.
Download this whitepaper to learn more about how Enterprise Quality Management Systems can help your pharmaceutical company.