On July 9, 2012, the President signed into law the Food and Drug Administration Safety and Innovation Act (FDASIA) (Public Law 112-144). FDASIA enables FDA to require standardized, fully electronic submissions for certain applications in an effort to facilitate FDA’s review.  To that end, the Agency is evaluating the use of electronic data exchange standards for receiving stability and other quality (chemistry, manufacturing and controls) data in eCTD submissions.  Also, we are investigating the efficiencies of standardizing other pharmaceutical quality data.

 

FDA is assessing the current HL7 eStability standard. The HL7 Version 3 Implementation Guide: Drug Stability Reporting (eStability) R2, Release 3, published in February 2012, provides technical conformance criteria for eStability files based on some of the same business rules and vocabularies used by the drug establishment, registration and listing process at the FDA.  The eStability R2 version implements, in electronic form, a model that is currently used for submission of stability data in paper and eCTD format.

 

FDA is also considering the feasibility of HL7’s FHIR technology for possible future use. 

 

For additional information on the current eStability data model, please see below.