Research On The Construction Of Chinese Pharmacovigilance System

Through the efforts of nearly 20 years in China's ADR monitoring work, China has established a basic framework of ADR monitoring system which is in a rapid development stage. However, there are still many weaknesses in China's ADR Monitoring. What's more, drugs safety issues include not only the ADR, but also drug abuse, misuse, overdose use, counterfeit and substandard drugs, and so on. Drug safety monitoring can't only remain in the ADR Monitoring stage. In order to ensure safety of drug use in public, we should establish a perfect pharmacovigilance system on the basis of current ADR monitoring system. Based on the background above, the paper is designed to establish a framework of phannacovigilance system which suits to China's situation.First, the paper introduced the theoretical knowledge of phannacovigilance, and the meaning of pharmacovigilance system, elaborated the origin of pharmacovigilance and the development of international pharmacovigilance, pointed out great significance of establishing a pharmacovigilance system. Then, the paper analyzed the current situation of pharmacovigilance work in China. At present, pharmacovigilance work in China is primarily ADR monitoring and it has established the basic framework of ADR monitoring system. Although China's ADR monitoring has made significant progress, but there are still many problems.This paper also described two models of pharmacovigilance system, that is the United States model on behalf of the central system and the French model on behalf of the local system, and did a systematic study on the pharmacovigilance system in this two countries including phannacovigilance legal system, organizational system, information collection systems, information evaluation system and information service system, and then draw some helpful inspirations in constructing a pharmacovigilance system.On this basis, the paper put forward strategies on how to establish a phannacovigilance system. The basic idea is to bring pharmacovigilance system into ADR monitoring System. Under the concept of pharmacovigilance, we should further improve the relevant technology system, and establish pharmacovigilance system in all directions, including establishing a perfect pharmacovigilance legal system, establishing a sound organizational system, establishing a pharmacovigilance data collection system, establishing a scientific pharmacovigilance data evaluation system and an open, transparent drug information service system.