Abstract: Objective According to the introduction of American New Drug Application for botanical drug, and the analysis of the characteristics of products which have been approved by FDA and our being declared products, 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. Case analysis was used to study the classic cases. Results The products which have been approved by FDA and our being declared products have the following characteristics: 1)Constituents/active ingredients are simple and clear. 2) Indications are single and mainly for the illness of unmet medical needs or chronic diseases. 3) Dosage forms are topical formulations or oral dosage forms. 4)Those products have a large number of basic researches and use experience. Conclusion Our traditional Chinese medicine enterprises should choose products with simple ingredients, topical formulations or oral dosage forms, and consider to develop international cooperation.

Key words: traditional Chinese medicine, registration, clinical trial application, new drug application