Whitepaper

Regulatory environment has become increasingly complex and making drug labeling a highly regulated and closely monitored activity. As some of you are aware, Health authorities are specific to regulatory requirements for medicinal products on labeling requirements such as patient information leaflets, package inserts and prescribing information packaging and artwork.

Industry experts estimate that between 35 to 40 percent of all product recalls are attributed to packaging and labeling errors as well as omissions. In fact, a recent report by AMR Research cited from Food and Drug Administration statistics which includes 455 product recall notices, 51 percent of them are because of mislabeling, and 13 percent are because of faulty packaging. Most of the regulatory inspection findings are associated with labeling issues by Health authorities such as US FDA, EMA, Canada, and others. All of them have a basic expectation “Product labeling must be compliant with the applicable local health authorities’ requirements for content, format, organization and structure. Labels should comprise of information on the safe and effective use of the drug. The label must be informative, accurate, not promotional, false or misleading. No implied claims or suggestions for use if evidence of safety or effective is lacking”. Let us see why this is complex when it comes to implementing the above.