Distribution to the US: quicker Import Decisions

The US Food and Drug Administration FDA is using a new automated system to assist in making import decisions for FDA-regulated products, called Automated Commercial Environment/International Trade Data System (ACE/ITDS). ACE is one of many tools FDA uses "to determine the admissibility of imports" (like for example inspections of manufacturing plants abroad, physical inspection of goods, and import alerts).

This system was developed in collaboration with the U.S. Customs and Border Protection (CBP) and 46 other U.S. government agencies. It serves a "single access point" for industry to submit data which is needed for import and international trade activities. After a pilot phase, put forward via a Federal Register Notice by CBP, the system became mandatory in July 2016 for everyone seeking to import FDA-regulated goods into the U.S.

According to FDA, the new system "has brought benefits to both government and the import community":

  • Less manual reviews of imports by FDA employees
  • Less requests for additional information from the importers
  • Less average processing time

However the system is still developing and will be further improved, based on feedback from the users but also on studies performed by FDA.

What leads to rejections?

  • An initial decision is made by CBP before transmitting shipments to FDA. The "most common errors" that lead to a rejection are:
  • Incorrect syntax or omission of required affirmations of compliance
  • Missing or invalid entity information, which identifies companies involved in the manufacture and importation of the product
  • Missing or invalid units of measure

The Authority itself has created an FDA Error Guide detailing the reject messages for incorrect or missing data entries.

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