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GUIDANCE DOCUMENT

CVM GFI #225 (VICH GL53) Electronic Exchange of Documents: File Format Recommendations September 2015

Download the Final Guidance Document Read the Federal Register Notice
Final
Docket Number:
FDA-2014-D-1177
Issued by:
Guidance Issuing Office
Center for Veterinary Medicine

The electronic exchange of regulatory documents concerning veterinary medicinal products between industry and regulatory authorities is commonplace. Global harmonization of the specifications for the electronic file format of documents is seen as a fundamental starting point to realizing the potential benefits.

The scope of this guidance is to cover the electronic file format specifications for individual documents and collections of multiple related documents that do not need subsequent modification during the regulatory procedure and are utilized for electronic exchange between industry and regulatory authorities in the context of regulatory approval of veterinary medicinal products. It applies to communication or data exchanged as documents in the context of all regulatory procedures where regulatory authorities accept electronic transfer of such documents. This may include but is not limited to 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, etc. (depending on a regional legislative situation).

This guidance provides different options and specific recommendations related to the electronic format of exchanged files. Following the recommendations outlined in this guidance will help ensure that electronic files are suitable and appropriate for regulatory review but will also involve complying with specific IT requirements.

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You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2014-D-1177.

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