Abstract: Objective According to the introduction of American OTC Drug Monograph, practical advice and help were put forward to provide the example and reference for our traditional Chinese medicine enterprises. Methods Literature study was used to analyze the foreign and domestic materials. Results The applicants can bring new active ingredients which are contained in their products into the existing monographs or make new monographs for them. Conclusion Our traditional Chinese medicine enterprises should choose products whose active ingredients have been contained in the existing monographs and have knowledge of all the discussion papers related to the targeted monographs. In Addition, the applicants should also pay attention to standardizing the labellings of botanical drugs, especially the readability requirements.

Key words: botanical drug, OTC Drug Monograph, citizen petition, time and extent application