International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH); VICH GL18 Draft Guidance on ``Impurities: Residual Solvents;'' Availability; Request for Comments

摘要

The Food and Drug Administration (FDA) is announcing the availability for comment of the following VICH GL18 draft guidance for industry entitled ``Impurities: Residual Solvents.'' This draft guidance has been adapted for veterinary use by the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH) from an identically titled guidance regarding pharmaceuticals for human use, which was adopted by the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). This draft guidance is intended to recommend acceptable amounts of residual solvents in new animal drugs (referred to as pharmaceuticals or veterinary medicinal products in the draft guidance) for the safety of the target animal as well as for the safety of residues in products derived from treated food-producing animals. It is intended to assist in developing new animal drug applications (referred to as marketing applications in the draft guidance) submitted to the European Union, Japan, and the United States.