Europe And The United States And China's New Drug Registration Approval System

The medicine and health system construction is an important focus of China government with the continuous development endeavor on it. But some deficiencies still exist in the Drug Registration Approval System. EU and US obssess the reputation for their upper-top class of the Drug Registration Approval System. Based on this point, literature retrieval and comparison method have been utilized in this paper, with the purpose to improve marketed drug quality and safety, and China Drug Registration Approval System, with the learning of advanced experience from EU and US, on the perspectives of the legislation system, the organization, the registration and approval procedures, the documents of registration application, etc.As the analysis outcome, the proposals are raised to improve the China Drug Registration Approval Mechanism as the followings:The legislation system basic frame of China Drug Registration Approval Mechanism has established and the system level still has the chance for improvement. And the technical guides is possible for the enrichment. Learning the EU & US management method for the "expert warehouse" could be helpful to resolve the shortage of the full time evaluation resource, and to improve the evaluation quality, which does good to the evaluation procedure of China Drug Registration Approval Mechanism. Learning the EU & US method of the risk management will improve the sponsor’s awareness to prevent the clinical study risk and avoid the drug quality inconsistency in clinical study. And learning the Adverse Event Reporting System from EU & US to establish the requirement that the sponsor shall take the repsonsibility for the adverse event reporting will be benefit to the clinical study safety surveillance. At the same time, learning the document requirement of the US clinical study registration, such as study result disclosure requirement in the China New Drug Manufacture Permit Approval, will enhance the clinical study data reliability.By learning the advanced experience from EU & US Drug Registration & Approval System, China could have the chance to achieve the further development of Drug Registration & Approval System and clinical trial safety, with regarding to legislation system, the organization establishment, the registration and approval procedures, the requiement of registration application documents.