新药(化学药品)申报资料中原料药制备工艺存在的问题

DEFECTS IN NEW DRUG (CHEMICAL DRUG) APPLICATION DOCUMENT FOR THE MANUFACTURE OF DRUG SUBSTANCES

总结了近几年在新药申报资料中原料药制备工艺存在的问题 ,并简单介绍了美国FDA在此方面的一些规定。

Defects in new drug(chemical drug)application document for the manufacture of drug substances have been summarized. Some rules in these sections of the FDA have also been introduced.