关键词: font-size:medium, ">药品；事中事后监管；备案；合规性

Abstract: The establishment of drug interim and ex post supervision mechanism is a key condition for the implementation of Drug Administration Law， Vaccine Administration Law， and the preparation of 14th Five-Year Plan of Drug Safety. Based on analyzing of the current system arrangements and regulatory technology status for the drug supervision mechanism， the author summarized the three aspects of the market subject， quality system and product about drug interim an ex post superision. The author analyzed the characteristics of the separation methods of licensing and supervision， technology and administration， and proposed that it is necessary to accelerate the trans formation of drug supervision methods to interim and ex post supervision. At last the author proposed to strengthen and standardized the drug interim and ex post supervision from the government coordination mechanism， credit supervision， big data decision-making， compliance system， and so on. Strengthening the drug entire process and risk management， and focusing on the administrtation science development， which would improved the reforming， safety， quality， and foundation of drug supervision. The drug administration bureau need to continuously improve the regulatory mechanism， innovate regulatory methods， and deepen the implementation of enterprise responsibility. Improveing the scientific， legal， international， and modern level of drug supervision， which would provided an effective decision-making reference for the promotion of the Two Laws and Two Regulations and the formulation of National Drug Safety 14th Five-Year Plan.

Key words: font-size:medium, ">Drug； Interim and ex post supervision； Recording； Compliance