Zdrowie i gospodarka · 01/09/2015

International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products; Electronic Exchange of Documents: Electronic File Format; Guidance for Industry; Availability

The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry (GFI #225) entitled "Electronic Exchange of Documents: Electronic File Format" (VICH GL53). This guidance has been developed for veterinary use by the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH). This VICH guidance document is intended 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.