| In 1950s, the climax of developing new drugs had appeaed all over the world. Because the variety and quantity of the drug was increasing, as well as combination therapy and long-term therapy, the world had focus on the severity of ADR gradually. In 1963, The United Nations recommended to set supervision system adverse drug reaction. In 1984, the "Drug Administration Law of The People's Republic of China" has been included in the re-evaluation of marketed medicines and adverse reaction supervision provisions. In 1998, the former State Drug Administration (SDA) enhanced the supervision of adverse drug reactions. In March of this year, our country joined in the WHO Collaborating Centre for International Drug Supervision formally, becoming the 68th member. However, because of the backwardness of adverse reactions supervision in our country, more than 20 years behind the developed countries, the work of monitore ADR is facing more difficulties.Through analyzing on the status and problems in ADR supervision system, this paper aim to find the negative factors in the implementation of ADR supervision, give concrete solutions about the laws and regulations, explore the ideas and concepts to develop ADR ideas and concepts, optimize the design and construction of the supervision system with drug manufacturers, pharmaceutical trading enterprise and medical organization, improve the pharmacovigilance system of work. In particular, through study on the effects of adverse facters on the ADR supervision system, this paper aim to identify the impact of the implementation factors of ADR, find the effect of drug supervision, raise the requirements. The meaning is to strengthen and standardize the content of Pharmacy Administration, provide suggestions and comments about drug supervision work and improve the rationality and security in drug use. |
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