About two years ago, in 2015, FDA launched an automated system for importers to submit shipment information for custom and FDA clearance and it has almost tripled the number of shipments that are cleared within minutes of arrival at the US ports allowing inspectors to quickly find the riskier shipments and focus their resources on managing them. The concept of the Automated Commercial Environment/International Trade Data System (ACE/ITDS) is pretty simply; check documentations automatically using software for accuracy, completeness, and authenticity to allow quicker release. Most imports used to get stuck with customs for easily addressable issues such as incorrect entries in forms, missing or invalid entity information or missing or invalid units of measure. The automated system checks for these errors, and flags the documents for the importer of record. This allows timely corrections thereby eliminating most of the reasons for hold and manual inspection. According to the FDA, most shipments are cleared within 2 minutes of arrival and the most of the ones that are flagged are cleared within 72 hours. Over the last few years, FDA has moved to increased electronic automated systems for most import and export issues and the Agency expects to go almost completed paperless by 2020 whereby practically all documents will be submitted to the FDA electronically increasing efficiency of review and improved management of resources.
Real-World Evidence in EMA Drug Approvals
November 13, 2025
