APCER Pharma Solutions, Inc. (“APCER”) President and CEO Suneet Walia commented on the US Food and Drug Administration’s (FDA) proposed rules to amend postmarket safety reporting regulations for three of its centers, to require manufacturers and other facilities subject to current reporting requirements to submit their reports electronically.
APCER is a leading provider of comprehensive drug safety, regulatory services and risk management programs for pharmaceutical, biotechnology, medical device and consumer products companies.
In response to these proposed changes, Mr. Walia commented, “This is a significant and ultimately a positive step that gives the Regulator the ability to timely monitor certain specific safety data of marketed products. Manufacturers shall still carry the primary responsibility to timely analyze safety data and signals and take actions based upon such analysis.
“The new rules will place some additional burden on companies that do not have validated solutions or resources to handle these processes. Manufacturers who can completely integrate their safety database and the electronic filing process stand to benefit the most.”