Investigation and analysis on the factors affecting the quality of chemical generic drugs in China
CHEN Zhen
YANG Jian-hong
ZHANG Yan-yan
HAN Peng
Abstract：A questionnaire survey was carried out to investigate the factors affecting the quality of chemical generic drugs in China,and most of the subjects confirmed the progress of the quality of chemical generic drugs in the past 10 years.The results showed that the R&D concept of chemical generic drugs in China has been changing,the international advanced R&D concepts and quality concepts have been gradually accepted by the industry.The results also showed that there are some issues affecting the quality of chemical generic drugs need to be further improved,with respect to the R&D capability,data integrity,registration management,technology requirements as well as market access policies.
Keywords：chemical druggeneric drugqualityquestionnaire survey
Publication Date：2017-01-01
Online Publishing Date：2026-08-14(First online date of this platform, not the publication date of the document)
Pages：7( 1477-1483 )