The Research Of Government Regulation For The Post-marketing Risk Management Of Pharmaceutical Companies

With the rapid development of China’s economy, as the life and health standards yearly enhancement, the drug safety paid more and more attention.2006" Houttuynia incident,"2007" methotrexate incident",2012," Roche incident " and drug safety incidents reflected two issues, firstly, The awareness of risk management of the pharmaceutical companies is not enough, It is not take the responsibility of the " primary responsibility for drug safety ". Secondly, the drug regulatory department supervision for the risk management is not in place, it is necessary to study on the government regulation for the drug post-marketing risk of enterprises and in-depth analysis and to provide reference for China’s drug safety supervision after the listing.We can get the following results from the above research. Firstly, the social regulation to the drug post-marketing risk management of production enterprise is scarce in our country. Such as regulations of inspection, certification and information disclosure. Secondly, the ADR information collection and analysis(evaluation) is seriously flawed.thirdly the information and relevant laws of regulation is the important factor for the effect of regulation.The fourth point is Government regulation for the post-marketing risk management of pharmaceutical companies existence the appropriateness.The fifth is the economic regulation can be taken to encourage to improve the efficiency of goverrnment regulation.The suggestion for the government regulation to pharmaceutical companies is pefect measures of social regulation. Such as establishing drug safety information disclosure system and ADR reporting and monitoring and inspection system; It should be clear the violations of enterprise and increase the penalties. For the administrative regulations, We should establish regulatory system of performance evaluation.and complete a good interface between the supervisory regulations and technical guidelines. The economic regulation ways to drug regulatory authorities is establish the incentive contract with the manufacturer.According to the contract, the drug regulatory authorities can take some some incentive and punishment to the enterprises. Realize the efficient and low cost regulation.The work of the government regulation for the drug post-marketing risk of enterprises is a long-term work, and need sum up the experience. Through the research and discussion in this paper, It is able to provide some useful reference for government regulation to drug post-marketing risk management in China.