Abstract

Developing a drug requires great amount of research work in chemistry, manufacturing, controls (CMC), preclinical science and clinical trials. Drug reviewers in regulatory agencies around the world bear the responsibility of evaluating whether the research data support the safety, effectiveness and quality control of a new drug product to serve the public health. This article provides an overview of the drug evaluation procedure implemented in China’s drug regulatory agency, State Food and Drug Administration (SFDA). Several unique features are discussed in details. This article provides insight into the drug evaluation system and requirements in China. As a developing country, China developed its own unique drug evaluation system along its drug development history while learning from those systems established in developed countries. China uses this system to reach a goal: ensuring safe and effective drug products for patients around the world.

Key words: China, State Food and Drug Administration (SFDA), Center for Drug Evaluation (CDE), drug evaluation system.