UPDATED August 31, 2015: The FDA has issued the final version of Guidance for Industry #225 (GL 53): Electronic Exchange of Documents: File Format Recommendations.
August 29, 2014
The U.S. Food and Drug Administration issued a draft guidance on August 28, 2014 to help standardize for global exchange the format of electronic veterinary medical product records. Draft GFI #225: Electronic Exchange of Documents: File Format Recommendations is built on a format already used by many in industry and by regulators and would provide a cost-efficient means to help standardize records.
This draft guidance recommends electronic file format specifications for individual documents and collections of multiple related documents that need no subsequent editing and are utilized for electronic exchange between industry and regulators in the context of regulatory approval of veterinary medicinal products. This draft guidance would apply to regulatory documents exchanged electronically, such as applications for initial marketing authorizations, related pre-submission or post-authorization procedures, applications for maximum residue limits, clinical trial applications, drug / active substance master files or requests for regulatory or scientific advice.
GFI #225 supports FDA’s work with the Veterinary International Conference on Harmonization (VICH), an international program aimed at harmonizing technical requirements for veterinary product regulation.
The FDA is accepting public comments on this draft guidance beginning on August 28, 2014. To submit your comments electronically to the docket, go to www.regulations.gov and type FDA-2014-D-1177 in the search box. The comment period will close on October 27, 2014. While comments are welcome at any time, you should submit them by the closing date for the FDA to consider your comments in drafting the final guidance.
To submit your comments to the docket by mail, use the following address. Be sure to include docket number FDA-2014-D-1177 on each page of your written comments.
The Division of Dockets Management
Food and Drug Administration
5630 Fishers Lane, Room 1061
Rockville, MD 20852
Federal Register Notice of Availability; Guidance for Industry: VICH; Electronic Exchange of Documents; Electronic File Format Regulations.gov
- Guidance for Industry 225: Electronic Exchange of Documents: File Format Recommendations (PDF - 113KB)
Veterinary International Conference on Harmonization (VICH) Guidance Documents