Problems and Regulatory Measures for the Implementation of Drug Clinical Trials in China
- VernacularTitle:我国药物临床试验实施中的问题及监管对策
- Author:
Yikang SUN
- Publication Type:Journal Article
- Keywords:
Drug clinical trial;
Problem;
Regulatory measures
- From:
China Pharmacy
2007;0(25):-
- CountryChina
- Language:Chinese
-
Abstract:
OBJECTIVE:To put forward suggestions for drug monitoring authorities to effectively supervise drug clinical trials.METHODS:Problems about the implementation of drug clinical trials and the problems faced by authorities were analyzed to propose regulatory measures.RESULTS & CONCLUSIONS:It is suggested that supervision and administration before and after the facts turn into process control,daily supervision and administration should integrate with checking register,rules and regulations should be improved and relevant responsibility should be implemented,the capability of supervisors should be improved.Drug clinical trial results are the key to drug development and evaluation.Strengthened supervision is the best way to improve the overall level of drug clinical trials in China.
