What reference material/guidance documents are available for the preparation of a disinfectant drug application?
When preparing a disinfectant drug application, applicants should familiarize themselves with the following reference material: • Health Canada’s Guidance Document: Disinfectant Drugs; • Health Canada’s Guidance to Industry: Management of Drug Submissions; • Canadian General Standards Board’s Document: CGSB-2.161-97, which refers to the microbicidal efficacy test standards; and Health Canada’s Health Products and Food Branch Inspectorate’s Guide-0049: Standard for the Fabrication, Control, and Distribution of Antimicrobial Agents for Use on Environmental Surfaces and Certain Medical Devices.
