Study On The System Of Adverse Drug Reaction Reporting And Surveillance In Pharmaceutical Manufacture

Drug is a double-edged sword. It plays the treatment effect, while it is also likely to cause adverse drug reaction (ADR) which is harm to the health. ADR reporting system in China was established at the end of the 1980’s. With the 20 years’ development, it has played an important role in protecting the public drug safety. Pharmaceutical manufacture as the first responsibility for the drug safety, ADR reporting and surveillance is the fundamental expression of its society responsibility. It is the need of ensureing the public drug safety and developing the manufacture’s own long-term plan. But the Chinese manufacture has not fully implemented due responsibilities and obligations of ADR reporting and surveillance. It not only restricts the effective propulsion of drug risk manageme, but also potencially causes the threat to the public drug safety. Therefore, to perfect the ADR reporting and surveillance system of pharmaceutical manufacture, it is the important issue need to be urgently resolved in current drug safety supervision areas.In the 1960’s, the European countries and U.S.A continueously established ADR reporting system. After almost half century’s development, they have formed a relatively complete system on ADR reporting and surveillance of pharmaceutical manufacture,and became the reference and model for other countries. So in this paper, it studied the pharmaceutical manufacture’s ADR reporting and surveillance system in the European countries and U.S.A, such as system installation, guideline formulation, specific implement,in order to find the framework on the regulation of pharmaceutical manufacture’s ADR reporting and surveillance system. All these findings will help to discover successful experience and learn the advantageous thinking.The paper also analysed the current situation and problems of pharmaceutical manufacture’s ADR reporting and surveillance in China. According to the system thoughts and risk management theory, the study was begun with the factors that affect the ADR reporting and surveillance of pharmaceutical manufacture and compared with the European countries and U.S.A. It has found the reasons of Chinese pharmaceutical manufacture’s ADR reporting and surveillance system. They are expressed in eight aspects, such as manufacture’s internal management requirements are not comprehensive, reporting requirements details are still lack, analysis and evaluation requirements are too apparent, regulation measures are expressed too simple, the duty of inspection are failed to regularly carry out, pre-marketing and postmarketing activites are still not well coordination, post-marketing surveillance working are not paid more attention in applying for the registration.Based on the analysis of domestic manufacture’s ADR reporting and surveillance system,and also considered national situation and overseas practical experience, some advice on the system was proposed to improve the relevant work. Firstly, according to the current regulations on ADR monitoring and surveillance of domestic manufacture, a series of proposals were put forward to promote the working prommance regularly and effectively,such as established the guidline on organization and reporting for manufacture, issued implement of regulations on intensive monitoring, improved the content and process of signal detection for manufacture, standarded the communication model between manufacture with the health provider and patience on drug safety. Secondly, from the development trend of the manufacture’s ADR reporting and surveillance working, some proposals were put forward to perfect the regulations, such as improved the reporting system on information effective collection, promoted to establish the risk management system and implemented the manufacture’s risk management plan, required the manufacture’s ADR reporting and surveillance system in the application for registration, introduced the qualified person on ADR reporting and surveillance to the regulation in time. Finally, according to the responsibility of authority, the proposals also were put forward to facilitate the compacy improved completely, such as played the regulator and inspection role, established the coordination mechanism in the relative department.The study on the system of domestic ADR reporting and surveillance of pharmaceutical manufacture is still very lack. With the study and discussion in this paper, hope to provide some useful reference on ADR reporting and surveillance in China. As the construction of ADR reporting and surveillance system of pharmaceutical manufacture is a kind of comprehensive work, there are many complicated factors exsited. At the same time the author’s knowledge is relatively limited, so the study also exists the shortcoming on the comprehensiveness and still needs to continuously perfect in the future.