Importers of FDA-Regulated Products Prepare for February Shift to Automated System

Posted 09 December 2015 By Zachary Brennan

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In partnership with Customs and Border Protection (CBP) and 46 other government agencies, the Food and Drug Administration (FDA) has developed and is quickly transitioning to a new portal through which industry can electronically submit all data required by government agencies for international trade.

As of 28 February, 2016, all importers and brokers of FDA-regulated products will have to submit entry data through the new Automated Commercial Environment (ACE). And by the end of 2016, ACE will be the primary system through which the trade industry will report imports and exports and the government will determine admissibility.

Doug Stearn, the director of FDA’s Office of Regulatory Affairs’ Office of Enforcement and Import Operations, told Focus: “Brokers must be licensed by CBP to access ACE, and we estimate that there are approximately 4,300 licensed brokers that file import entries related to FDA commodities.  While importers that do not act as brokers will not be accessing the system directly, importers will be affected and should be familiar with the system.”

As far as how ACE is an improvement on ACS, Stearn explained that the new system “moves certain paper process into an automated format where entries can be processed more quickly, reduces or eliminates redundant reporting, and provides unified messaging on behalf of the government.”

In addition, ACE will be able to validate data at the time of submission “so that there will be fewer processing delays which can slow things down when additional information must be submitted and reviewed.  ACE also will provide more specific messaging at the line level for commodities admitted on this basis, streamlining the process by delinking each product line from other goods during the process,” Stearn added.

And although industry will have to adjust to the changes quickly, Stearn told Focus that CBP and FDA “believe industry is hopeful about the promise of the new system, but has been cautious about participating.  We are asking industry to participate in the pilot and help us realize the vision of the new system.”    

FDA Video on ACE

Automated Commercial Environment/International Trade Data System (ACE/ITDS)

FDA Supplemental Guidance for the Automated Commercial Environment/International Trade Data System (ACE/ITDS) Version 2.4

ACE Mandatory Use Dates

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Categories: Active pharmaceutical ingredients, Biologics and biotechnology, Combination products, Drugs, Medical Devices, Orphan products, Audit, Distribution, Government affairs, Quality, News, US, Canada, Europe, Asia, Latin America and Caribbean, Africa, Middle East, Oceania, FDA

Tags: FDA imports, import alert, ACE, CBP

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