The drug registration application.

PURPOSE. This article is used to give a brief overview for people who would like to submit a drug registration application in China, or for those who would like to get a broader international drug registration perspective. METHODS. This paper concretely describes the new items in the current drug registration application through introducing following contents: qualification of the applicant, registration classification or type, the procedures for drug registration application review, the intellectual property rights concerning the pharmaceutical (drug substance and product), the process for submitting a drug registration application and the materials required in application for registration. RESULTS. From the paper, we have a comprehensive knowledge of drug registration application in China. CONCLUSIONS. The current Provision for Drug Registration is more reasonable and suitable for China's entry into WTO and further guarantee that safe and effective drugs are available to Chinese people.