eCTD ANDA Submission Statistics
FY 2009
•859 ANDAs submitted in FY 2009
•263 PIV submissions
409 eCTD submissions
242 CTD submissions
30 paper CTD submissions
178 Gateway submissions
8 ANDA's RTR's (Refuse to Review) in FY 2009
FY 2010
•813 ANDAs submitted in FY 2010
•262 PIV submissions
119 CTD submissions
271 eCTD submissions
12 paper CTD submissions
411 Gateway submissions
13 ANDA's RTR'd in FY 2010
FY 2011
•853 ANDAs submitted (as of 9/26/2011)
•211 PIV submissions
60 CTD submissions
177 eCTD submissions
5 paper CTD submissions
611 Gateway submissions
•48 ANDAs RTR’d (as of 9/26/2011)
Relevance of numbers
100% of Original ANDAs being submitted are in CTD format (eCTD+paper CTD+Gateway)
Approximately 95% (or more) of original submissions are now electronic
Gateway submissions have continued to surge tremendously
58=(2008) 178=(2009) 411=(2010) 611=(2011)
RTR's as a percent of submissions is about 17% (data is incomplete as all of FY 2011 submissions have not been reviewed) FY 2008=15%, FY 2009=9%, FY 2010=14%
FDA currently has approximately 2500 ANDA's under review
FDA currently has approximately 4900 CMC Supplements under review
*All information above from GPhA Technical Conference held in Bethesda, MD - Oct 3-5 Kwadwo Awuah, Pharm D., R.Ph,. Regulatory Support Management Officer, Office of Generic Drugs, FDA
Industry average ANDA approval times are approximately 33 months, industry has done an excellent job converting to electronic ANDA filings from paper.
The focus for industry remains to provide the FDA 'well written' ANDA applications, this will assist the FDA with more efficient review times.
Custopharm filed the 1st eCTD ANDA in 2004, have filed over 100 since. Custopharm assists companies by through Regulatory assistance, when we fully write eCTD ESG ANDA's the average approval time is significantly faster than the industry average.
Best,
Dave McCleary
dmccleary@custopharm.com