ABSTRACT
OBJECTIVE： To provide reference for further improving China’s Good Manufacturing Practice （GMP） compliance inspection information and the construction of related database. METHODS： The relevant information on drug GMP compliance inspections from the websites of drug administration departments in China and America were collected， compared and analyzed from the aspects of the format and content of inspection report， annual report and database construction. The suggestions were put forward for the improvement of China’s drug inspection information and related databases. RESULTS & CONCLUSIONS： There was a large gap in the compliance inspection information and database functions between China NMPA and US FDA. For the drug GMP compliance inspection information， US FDA had established a special database to facilitate the public to use the search information， and had advanced search capabilities. At present， the database in China was not perfect and not a true meaningful database. It can only be browsed in order， and had almost no search function. In the content of drug GMP compliance inspection information， US FDA had made scientific and humanized measures for the description of defects， the advice or assistance provided to enterprises， and the confidentiality of key data， and the publication was timely. The details of the flight/tracking inspection notifications related to drug GMP compliance inspection issued by China CFDI were slightly poorer， and the classification of defects was not clear. The period from the end of the inspection to the release of the notification was longer. It is suggested that China’s drug GMP compliance inspection information and database functions should be improved from expanding the types and scope of GMP inspection information， improving the search function， and providing database instruction manual and refining the report content.