Abstract: OBJECTIVE To further standardize declaration of excipients in the labelling and package leaflet of medicinal products, ensure the public safety and promote rational drug use. METHODS Domestic and foreign relevant rules and regulations were compared, and suggestions to improve declaration of excipients in the labelling and package leaflet of medicinal products were put forward. RESULTS Relevant regulations and technical guidance system still need further perfect in China. CONCLUSION The top-level design and overall planning is required to formulating relevant rules and regulations in China, the definition of excipient and the scope of declaration should be clearer, and corresponding technical guidelines should be formulated.