Chinese Pharmaceutical Risk Management Practice Study

Drug risk management has emerged and been developing gradually under the circumstances of accelerating drug approval procedure to speed up the launch of new drugs to market on one hand, while withdrawing drugs from market due to safety problems on the other hand. Along with the continuous improvement of drug administration, the development of drug risk management has shown the unpreventable tendency—the risk of drug need to be evaluated continuously, and risk management plan should be designed according to the result of evaluation; therefore, the known risk of drug could be controlled at the lowest level through the appropriate strategies of risk management while ensuring the effectiveness of drug.The United States of America is one of the leading countries which have applied the theory of risk management in the drug administration sector. The drug risk management in USA has undergone a developing process, which initially relied on the ADR monitoring system. Later the concept of drug risk management has been developed and updated through reinforcing the legislation, restructuring the organization and establishing guidelines under the increasing pressure for drug administration.The drug risk management in USA has been relatively mature nowadays: the drug risk has been managed throughout the whole process from the pre-market evaluation and the post-market reassessment; the decision-making procedure and implementation of measures have been disclosed to the public timely; the responsibilities over drug risk has been shared by FDA, pharmaceutical enterprises, health service providers and patients; the epidemiology research methods have been fully applied to evaluate the drug risk factors; the measures for risk management have been raised after complete evaluations; the measures have been individualized according to the different risks from diversified drugs; and the communication between the doctor and the patient regarding the perception of drug risk has been emphasized, etc.The drug risk management has been introduced late in China and is still at the initial stage. In recent years, there have been many achievements obtained in exploring the drug risk management: the continuous improvement of laws and regulations regarding drug safety administration; the gradual enhancement of the administrative organizations and corresponding responsibilities; the increasing annual amount and quality of ADR case reports; the establishment of routine publication of ADR information; the reinforcement of administrative efficiency from multi-dimensions including the approval of market entry, various certifications and the classified administration. A number of serious drug safety events occured recently have revealed the embarrassing status of passive drug safety administration in China. In this regard, the importance of drug risk management has been realized consequently. Several seminars on drug risk management were held, and the "risk management scheme on high risk drug" was further conducted by the government in 2008. All these imply that the government has been getting conscious to regard the drug risk management as the crucial issue and future direction for drug administration.With the respect of the current issues on drug risk management in China, including the generally inadequate perception about drug risk and risk management, the low responsibility of enterprises which should act as the principal role in implementing risk management, the imperfection of organizational system for drug risk management, the weak capability on post-market surveillance and evaluation, the tendency of simplification through administrative measures for risk management, and the inapt connection between the communication of drug risk information and the drug application status quo, this article suggests several primary strategies in order to enhance and refine the drug risk management in China: to improve the general perception of drug risk throughout the whole society; to emphasis the responsibility of enterprises which should be the primary actor for implementing risk management; to reinforce and amend the organizational system for drug risk management; to refine and optimize the construction of ADR monitoring system; to adopt multi-dimensional and focused measures on drug risk management; to enhance the communication with the public and ensure the transparency of risk information; and to establish a series of guidance on implementing drug risk management; to shape a cooperative drug risk management model.