Abstract:This study provides an overview of the latest reforming policies affecting the dilemma faced by Chinese drug evaluations and approvals system. Drawing on the policies and current realities, we found the main problems of the old system were low drug quality, the serious backlog of drug evaluation and approval and the deficient of drug innovation. The latest reforming policies are aiming at these problems, improving drug evaluation and approval standards and optimizing the process, carrying out generic drugs’ quality and efficacy consistency evaluation, self-examing and verifying of drugs’ clinical experiment data, encouraging drug innovation, verifying drug producing techniques, setting up and completing safeguarding measures. These policies have positive roles on not only the supervision departments but also the drug researchers and producers, and the backlog of the evaluation and approval cases decrease significantly. The new problems also emerges from the reform , the professional personnel of drug evaluation and approval is inadequate and drug producing enterprises can hardly be adapted to reforming policies within a short time, what’s more the joint collaboration between each governmental department is not up to the mark. Overall, this study finds the main problems of both old and new Chinese drug evaluation and approval system, also suggests approaches towards improving reforming policies.