Abstract:Analysis has been made on the key factors in production processes that have an impact on the safety of marketed traditional Chinese medicinal products based on literature research, current production situation, and practice of reviewing the protected products. It has been found that production process, technology changes, and novel technology all play certain role in safety of marketed traditional Chinese medicinal products. Therefore, the following recommendations have been made: to strengthen the fundamental research, establish in-house quality control with higher quality standards than current national quality standards, strengthen validation of production processes, make better use of the protection system to improve quality of traditional Chinese medicinal products.