US FDA's new measures for strengthening drug safety administration
- Author:
Ruo-Ming ZHANG
1
Author Information
- Publication Type:Journal Article
- Keywords: Drug; Risk management; Safety regulation
- From: Chinese Pharmaceutical Journal 2015;50(10):913-915
- CountryChina
- Language:Chinese
- Abstract: OBJECTIVE: US FDA's drug safety regulatory new initiatives was interpreted and analyzed to provide lessons for China's drug administration. METHODS: By interpreting US FDA's relevant guidelines on drug safety administration, the measures on strengthening the safety administration, risk assessment and post-market surveillance were introduced and discussed. RESULTS: Lessons was learned by analyzing the successful experiences of FDA drug safety administration and risk management. CONCLUSION: China's drug administration need to take steps to keep focus narrow, attach importance to administrative methodology and innovate policies based on the lessons from US FDA and China's current drug regulatory conditions.
