Electronic 'Safety Reporting Portal' launched
May 25, 2010
WASHINGTON –A new web site was launched on May 24 by the Food and Drug Administration (F.D.A.) and the National Institutes of Health (N.I.H.) that when fully developed will provide a mechanism for the reporting of pre- and post-market safety data to the federal government. At present, the web site can be used to report safety problems related to foods, including animal feed and animal drugs, as well as adverse events occurring on human gene transfer trials.
Named the Safety Reporting Portal (S.R.P.), the new site provides greater and easier access to online reporting, according to a news release.
“The portal will be a key detection tool in improving the country’s nationwide surveillance system and will strengthen our ability to protect the nation’s health,” said Margaret Hamburg, commissioner of Food and Drugs. “We will now be able to analyze human and animal safety-related events more quickly and identify those measures needed to protect the public.”
The new Web portal includes different features for different types of reporting:
• Reportable Food Registry -- Industry will have a more user-friendly electronic portal for submitting reportable food reports required by law. This electronic portal collects reports from the food industry and public health officials regarding problems with articles of food, including animal feed, that present a reasonable probability of causing serious adverse health consequences or death to humans or animals.
• Pets – Pet owners and veterinarians will be able to use the portal to report product problems with pet foods and pet treats.
• Animal drugs – Animal drug manufacturers can report adverse drug events associated with animal drugs.
• Clinical Trials – Biomedical researchers involved in human gene transfer clinical trials can report an adverse event, indicating whether it might be an unanticipated consequence of the product being tested. Trial sponsors can use the portal to prepare a report, print it and send it to the agency to satisfy reporting requirements for investigational new drugs.
The system will encompass other types of clinical trials in the future and eventually, safety problems arising from products regulated by a broad array of federal agencies. This is a first step toward a common electronic reporting system that will offer one-stop shopping, allowing an individual to file a single report to multiple agencies that may have an interest in the event, F.D.A. relays.
Equally important, the portal will ultimately enhance the government’s systematic analysis of safety information, which will benefit public health. Meanwhile, the new portal redirects individuals who want to submit reports about other products regulated by F.D.A., the U.S. Department of Agriculture, Environmental Protection Agency or the Consumer Product Safety Commission to the appropriate contact.