FDA Will Continue Inspection Efforts at Foreign Drug-Manufacturing Facilities in FY 2015


From DCAT Value Chain Insights (VCI)

By Regulatory News posted 03-17-2014 18:41

  
In the US Department of Health and Human Services Fiscal Year (FY) 2015 budget request, released earlier this month, FDA outlined its plans for inspections of domestic and foreign drug establishments, which includes pre-approval inspections (PAIs) for new drug applications (NDAs) and abbreviated new drug applications (ANDAs) as well as drug processing (GMP) inspections. Overall, the agency plans to continue inspections at a similar pace in FY 2015 as estimated for FY 2014, which saw an increase in the inspections of foreign drug-manufacturing facilities.

In FY 2013, FDA conducted 1851 domestic inspections, and it is expected that this number will rise slightly to 1856 inspections in FY 2014 (which ends on September 30, 2014), the same level the agency expects to have in FY 2015. This total includes PAI inspections and GMP inspections as well as bioresearch monitoring program inspections, compressed medical gas manufacturers inspections, adverse drug events project inspections, and over-the-counter monograph and health fraud project inspections.

FDA conducted 112 PAIs for NDAs  at domestic manufacturing facilites  in FY 2013, and the number of PAI inspections are expected to  to increase to 171 in FY 2014, which is the same level targeted for FY 2015. There were 117 PAIs for ANDAs for domestic manufacturing facilites in FY 2013, which is projected to rise to 216 in both FY 2014 and FY 2015.

GMP inspections at domestic manufacturing facilities, however, are expected to decline in FY 2014 and FY 2015 compared to FY 2013 levels due to an increase in inspections at foreign drug-manufacturing facilties. GMP inspections of domestic manufacturing facilities equaled 967 in FY 2013, but this level is expected to fall to 591 in FY 2014 and stay at 591 again in FY 2015. At the same time, inspections of GMP inspections at foreign facilties are expected to increase. In FY 2013, FDA made 604 GMP inspections of foreign drug-manufacturing facilities. In FY 2014 and FY 2015, this level is projected to increase to 843 inspections.

Overall, FDA inspections of foreign drug establishments are expected to increase from 827 inspections in FY 2013 to 999 in both FY 2014 and FY 2015, which includes 17 inspections in China and 50 inspections in India. This total number of inspections includes PAI and GMP inspections as well as bioresearch monitoring program inspections and adverse drug events project inspections  

Although GMP inspections will increase at foreign drug-manufacturing facilities, PAI inspections for both NDAs and ANDAs are expected to decrease in FY 2014 and FY 2015 comparative to FY 2013. In FY 2013, FDA conducted 163 PAI inspections for NDAs of foreign drug-manufacturing facilities and is expected to make only 98 in both FY 2014 and FY 2015. In FY 2013, FDA conducted 141 PAI inspections for ANDAs at foreign drug-manufacturing facilities, and this level is expected to decline to 83 PAI inspections in both FY 2014 and FY 2015.

Source: US Department of Health and Human Services
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