In 2012, China issued the healthcare programs of the "12th Five-year Plan" in succession, providing the guidance for regulating change of the economic development mode of the medical industry and improvement of the drug quality;and pharmaceutical companies made the effective structural adjustment while the distributors proceeded slowly in structural adjustment, the exciting results were obtained in the innovative drug research and development, and the ability for ensuring drug safety has been improved significantly. We made the detailed analysis on the development condition of the medical industry in China, the medical "12th Five-year Plan", the drug regulatory policies and the condition of drug safety;and proposed to perform the quality conformity of generic drugs, promote the new GMP certification, enhance the international cooperation in drug regulation, improve the professional and technical level of regulations, and conduct and encourage the regular special rectifications and the industrial self-discipline management of companies during the "12th Five-year Plan". <<