Overview of China’s pediatric drug situation and regulatory policy / 国际药学研究杂志

ABSTRACT

Pediatric drug accessibility has become a global problem, pediatric drug shortages and off-label uses are very serious. In China, lack of suitable varieties, appropriate dosage forms and specifications, weak foundations on clinical trials, irregular prescribing behavior and irrational drug use and other issues on pediatric drugs are still outstanding. To improve pediatric drug accessibility, it may need all aspects work together, that is, cooperation of the national macro-policy support, participation of enterprises and medical institutions, to establish realistic goals and programs to address pediatric drug problem. This paper studies the foreign pediatric regulation measures and policies and by comparing foreign policies to China’s current situation, we can find out the problems and defects, give appropriate advice, in order to provide advice and reference to promote the development of pediatric drug.