How do I proceed to commercialize a disinfectant drug product that has been identified as a “New Drug”?
When a disinfectant drug product is determined to meet the requirements of a “new drug”, as defined in Division 8 of the Food and Drug Regulations, an applicant must submit a New Drug Submission instead of a DIN application. Prior to submitting an application, applicants could request for a pre-submission meeting to better understand the submission and evidence requirements necessary to support such a submission. For information on pre-submission meetings and package requirements, please consult the Guidance to Industry: Management of Drug Submissions.
