Regulatory Roundup: Week of July 30, 2012

Aug 01, 2012
By PharmTech Editors

FDA has announced rates for prescription drug user fees for fiscal year (FY) 2013, as authorized by the Prescription Drug User Fee Amendments (PDUFA V) signed into law on July 9, 2012. FDA is required to set fee revenue amounts for applications, establishments, and products each year. The FY 2013 rates, effective Oct. 1, 2012 through Sept. 30, 2013 as listed in the Federal Register, are: application fees for an application requiring clinical data, $1,958,800; an application not requiring clinical data or a supplement requiring clinical data, $979,400; establishment fees, $526,500; and product fees, $98,380. The new fee schedule applies to applications and supplements submitted on or after Oct. 1, 2012.

Cooperation and interaction between Japanese and European pharmaceutical regulators has improved since 2009, according to a report released by the European Medicines Agency (EMA). EMA reports an increase in the exchange of information and interaction between the two regions, including a new Japanese liaison officer and increased conference attendance. According to EMA, the areas of orphan drugs, pediatrics, advanced therapies, pharmacogenomics, and nanomedicines have especially benefited from the new Japan and EMA cooperation.