FDA Update: electronic submissions statistics

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Electronic regulatory submissions sent to the U.S. Food and Drug Administration have increased year-by-year since the electronic system was launched in 2009, the FDA reports.

The agency’s Electronic Submissions Gateway offers a secure entry point for companies and FDA partners to send documents containing premarket and post-market regulatory information on pharmaceuticals and medical products, according to the FDA.

The system has increased regulatory efficiency, reduced paper document submissions and greatly reduced shipping expenses, the FDA said.

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Electronic Submissions Gateway Total Submission Statistics

Submission Types	2009	2010	2011	2012	2013	2014	2015	2016	2017	2018	2019	Totals
Adverse Event Reporting System	300,672	472,142	557,917	717,345	876,475	1,026,314	1,321,114	1,533,378	1,698,094	2,118,827	1,304,627	11,926,905
Center for Drug Evaluation and Research	45,510	69,739	93,503	107,681	124,232	139,322	159,515	165,932	189,141	221,471	136,147	1,452,193
Center for Biologics Evaluation and Research	4,483	5,588	6,397	6,927	8,412	9,506	11,294	20,278	52,197	56,044	39,588	220,714
Center for Devices and Radiological Health	21,296	119,087	280,312	462,316	666,927	812,443	1,478,524	2,032,767	1,921,871	2,247,286	1,470,396	11,513,225
Center of Veterinary Medicine	859	2,083	20,462	37,928	40,978	44,607	52,601	64,197	70,436	70,682	42,802	447,635
Office of the Commissioner	16,275	48,232	55,676	64,285	65,430	68,171	60,943	56,517	71,545	77,353	34,009	618,436
Center for Tobacco Products	5	223	348	642	1,237	324	734	612	23,984	19,142	2,035	49,286
Affordable Care Act				62	207	195	212	228	218	236	264	1,622
Generic Drug User Fee Amendments				2,771	2,926	3,547	2,906	1,644	1,600	1,455	1,113	17,962
Center for Food Safety and Applied Nutrition				458	4,220	2,756	3,761	3,619	2,661	2,421	1,430	21,326
Health Canada					324	5,835	9,366	16,497	23,595	26,927	16,289	98,833
Totals	389,100	717,094	1,014,615	1,400,415	1,791,368	2,113,020	3,100,970	3,895,669	4,055,342	4,841,844	3,048,700	26,368,137

Source: U.S. Food and Drug Administration