Research on american regulations of drug manufacturing site changes / 中国药学杂志

ABSTRACT

OBJECTIVE: To put forward some suggestions on drug manufacturing site changes for our country. METHODS: By studying American regulations of drug manufacturing site changes, analyze its advantages in regulations. RESULTS AND CONCLUSION: It's suggested that We should apply the risk-based approach to classify drug manufacturing site changes, focus more on high-risk manufacturing site change to lighten the burden of the agency and corporations, and liberalize drug manufacturing site changes to promote smooth implementation of the marketing authorization system.