International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH); VICH GL11 Draft Guidance on Impurities in New Veterinary Medicinal Products; Availability; Request for Comments

摘要

The Food and Drug Administration (FDA) is announcing the availability for comment of a draft guidance developed by the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH). This VICH GL11 draft guidance for industry entitled ``Impurities in New Veterinary Medicinal Products'' provides guidance recommendations for applications for marketing authorizations on the content and qualification of impurities in new veterinary medicinal products produced from chemically synthesized new active substances not previously registered in a member state.