APCER comments on FDA's decision regarding electronic submission of reports

Sep 9 2009

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.”

Barton Cobert, MD, Pharmacovigilance Strategy & Client Services Advisor for APCER, commented, “This is a very satisfactory decision that aligns FDA with global standards that the EU, Japan and others have been following for quite some time. This is a logical outcome since FDA, along with the EU and Japanese regulators and industry, myself included, designed the electronic standards in the International Conference on Harmonization. This should make safety reporting easier and more consistent globally - ultimately improving patient safety at lower cost. A win-win. Those companies not doing this already now have to move quickly to set up a validated electronic reporting system either in-house or externally."

“This is where APCER steps in,” said Suneet Walia. “We have a team with significant experience to do the actual electronic reporting on behalf of our clients. We use one of the leading adverse events reporting systems on a hosted platform to handle these requirements at virtually a fraction of the cost of what it would normally cost a company to implement its own system. The system provides complete visibility and control to our clients while our trained team does the day to day safety case processing and reporting.”

The FDA news release is available at http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm179596.htm