Designing a new model for cosmetic adverse reaction monitoring in China.

ABSTRACT

BACKGROUND: The monitoring of cosmetic adverse reactions (CARs) in China has progressed to a new stage of development because of government institutional reforms. OBJECTIVE: To discuss and formulate an appropriate model for CAR monitoring in China. METHODS: The formulation of a new CAR-monitoring model under the administration of the Food and Drug Supervision Department is discussed on the basis of China's current national conditions and with reference to the previous CAR-monitoring and drug-monitoring models of the organization formerly known as the Ministry of Health of the People's Republic of China. RESULTS: The preliminary design of the CAR-monitoring model is considered to be a long-term development goal of CAR monitoring. The monitoring model at this stage was developed on the basis of China's national conditions; specifically, the development of a two-level (national and provincial agencies) monitoring system that relies on CAR-monitoring sentinels, and reports that cover CARs with definite causal associations. CONCLUSION: This model is developed on both theoretical and practical foundations, and can function as a proper monitoring model at the initial stage of current CAR monitoring through an appropriate pilot programme, exploration, and improvement.