Drug regulation is the most important policy to ensure drug safety.In this article,we analyzed institutional changes and problems in China's drug regulation.In addition,suggestions were provided to enhance the capaci...
Stakeholder analysis was conducted to define stakeholders and their role in clinical trials; a conceptual model and hypotheses regarding the relationship of each stakeholder were then constructed based on pharmaceutic...
This paper presented detailed information about the timeline of development of drug risk management in FDA. The time process was divided into three stages: the launch of laws and regulations of drug risk management, ...
This article explored the definition, dimensions, and building mechanisms of drug regulatory capabilities(DRC) and their relationship with regulatory performance. Based on the theories on organizational capability a...
To evaluate the impact of GMP on Chinese pharmaceutical industry in a quantitative system, we referred to theories on policy evaluation and industrial organization, and conducted literature review, key person intervie...