Study on the Implementation of American Post-marketing Re-evaluation of Drugs Legal System and Its Enlightenment to China
- VernacularTitle:美国药品上市后再评价法律制度实施的研究及其对我国的启示
- Author:
Qi ZHANG
1
;
Jianzhou YAN
1
;
Xufeng MA
1
;
Rong SHAO
1
Author Information
1. National Drug Policy and Medical Industry Economy Research Center of China Pharm aceutical University，Nanjing 211198，China
- Publication Type:Journal Article
- Keywords:
Post-marketing re-evaluation of drugs;
Legal system;
American FDA;
Enlightenment
- From:
China Pharmacy
2019;30(15):2017-2022
- CountryChina
- Language:Chinese
-
Abstract:
OBJECTIVE： To provide reference for the establishment and improvement of the post-marketing re-evaluation of drugs （shorted for re-evaluation） legal system in China. METHODS： Through sorting out American re-evaluation system， this paper focused on the current situation and procedures of the implementation of American re-evaluation system and put forward the suggestions for improving drug re-evaluation system in China. RESULTS & CONCLUSIONS： American re-evaluation system takes enterprises as the main body of execution and the government as the main body of supervision. It has the characteristics of highly informatized and transparent process. The work includes the report of ADR implementation of monitoring systems， the periodic reporting system and the post-listing clinical trials and research systems. The implementation process is to find clues， FDA preliminary review and notification， enterprise further self-examination and review， corporate actions and accept FDA supervision. It is suggested that when establishing the legal system of re-evaluation system in China， the main role of patients should be highlighted， and risk communication should be guided by the public. For example， the Medwatch voluntary reporting system of FDA can be imitated. The unified data collection， storage system and scientific data processing methods can be established. Continuously strengthen the main responsibility consciousness of pharmaceutical enterprises in testing and reporting， and constantly reduce the risk of drug use of patients.
