Posted 30 November 2016
By Michael Mezher
The US Food and Drug Administration (FDA) on Tuesday issued a final rule requiring companies to submit data for FDA-regulated products via a new electronic system intended to serve as a "single access point" for imported products.
Specifically, the final rule, which takes effect on 29 December 2016, will require companies to submit the data through the Automated Commercial Environment (ACE), which was developed in collaboration with US Customs and Border Protection (CBP) and 46 other government agencies.
According to FDA, the ACE system will help it meet the growing challenge of overseeing FDA-regulated imports into the US, which the agency says have increased nearly six-fold since 2002.
"As a result of the more streamlined import process for FDA-regulated products provided by ACE, the rule is expected to lead to an efficient use of FDA and importer resources, and more effective enforcement of laws and regulations enforced by FDA," said FDA Deputy Commissioner for Global Regulatory Operations and Policy Howard Sklamberg.
Under the final rule, importers will be required to submit the following information for food contact substances, drugs, biological products, HCT/Ps (human cells, tissues, and cellular and tissue-based products), medical devices, radiation-emitting electronic products, cosmetics and tobacco products:
- Product identifying information for the article that is being imported or offered for import:
- FDA Country of Production
- The complete FDA Product Code
- The full Intended Use Code
- Importer of record contact information.
The rule also describes specific requirements for each product type. For instance, for human drugs, importers are required to include registration and listing information, the drug application number and the investigational new drug application number.
FDA, Final Rule