In spite of a long process of serious and complicated clinical trial during the research course of any drug, the occurrence of ADR is still inevitable. It appears to be normal to discover new dangers associated with a new drug after its delivery to the market, and this problem has become more serious than before. Hence, the WHO is very concerned about the relevant surveillance of ADR effects. In fact, the WHO requires every member country to develop and maintain a set of international standards for all the drugs that have been delivered to the market. It tums out to be true that the safety surveillance of the drugs on the market is more important. In order to enhance the surveillance of ADR. Those supervising departments on drugs in many countries have stepped up the information collecting systems about ADR, as well as modifications of relevant drug supervising regulations. In short, enhancing ADR surveillance has become a main function of the Drug Supervising Department in many countries worldwide. In Hong Kong, a report system on ADR was established in October, 1986. As an international city, Macao has to speed up the process of setting up a well-established ADR report system for the purpose of keeping up pace with the advanced management skills on safety use of drugs. With a thorough understanding of the difficulties and conflicts associated with the ADR report systems being used in the world, this thesis aims at developing applicable methods and strategies suitable for Macao's ADR survillance system. This is by means of taking references to relevant reports and research of the ADR systems adopted by the more advanced countries in this field including U. $. A., China and Europe. By the same token relevant experiences of the adjacent countries and cities of Macao, including Taiwan Singapore and Hong Kong, with regard to ADR concepts are considered and evaluated How to select the most appropriate ADR devices which can fit the needs of this city turns out to be the core of the study, with a hope that the research result can point to the right direction of an effective ADR system of surveillance of Macao. This thesis is divided as four parts as follows:(1)To look into the report system, origins of reports, scope of reports, requirements of reports, report handlings and data feedbacks of the various ADR reporting systems among China, U. S. A., Europe and those countries or cities which are adjacent to Macao, with similar characteristics in order to understand the mechanism differences of each own, and alos comparisons are made. The results show that process of implementing the report system varies due to differences existing among medical systems and the development of production and sales systems of pharmaceutical products in different countries. (2) To look into the problems encountered with ADR reporting system in the world by analyzing relevant articles and making comparison studies. These include studies on limitation of surveillance on voluntary reporting system, a lack of an efficient and systematic method on ADR analysis, and inadequate knowledge of professionals.(3) To understand the problems that the city will encounter while carrying out and ADR reporting system by visiting expert professionals in this regard, along with necessary site visits. At final, conclusions will be drawn by proposing solutions and appropriate strategies on a successful ADR reporting system.(4)To make a conclusion based on all the data and experiences mentioned above, and to come up with an applicable ADR reporting system for the Macao area. Key words: Pharmacovigilance, ADR, Spontaneous reporting

藥物由研發到推出市场，雖然經通了一連串嚴謹及繁複的安全和有效性試驗，但是 ADR 的發生還是無法避免。上市後發現菜物新的危害是常见现象，且有日益嚴重的趨勢。藥物的不良反應監测受到 WHO 的開注。在 WHO 憲章内要求各成员國開展、建立、促進及维持已上市藥物的國際標準，其中藥物上市後的安全監测工作尤為重要。為此ADR監测成為各國藥物監管部門的重要職责，世界各紛纷加快了對藥物不良反應信息收集系统的建立，並進一步完善藥物管理法规。鄰埠香港亦早於1986年10月推行了藥物不良反應通報。澳門作為一先進的國際都市，在藥物安全性管理上不能有所滞後，澳門特區衛生局必须努力，儘快開展有關工作。 本論文主要透過文獻研究，了解及分析際先進國家(包括美、中國及歐盟)以及鄰近與澳門情况相類似之地區(包括臺灣、新加坡及香港)的藥物不良反應監测制度及執行經驗，並從各方面了解國際上 ADR通報制度在執行上存在的困難及冲突，取長補短，探討適合澳門實際情况的不良反感通報制度及方法，從而为澳門物不良反監管提供發展方向及策略。 本論文分為四個部分進行探討: 第一部分，主要從報告制度、報告来源、報告範圍、報告要求、報告處理、信息反饋等方面比较了中國、美國、欧盟及與澳門情况相類似之鄰近地區的物不良反感通報制度，以瞭解各自存在的差異。结果顯示各國及地區因應本身的醫療以及物製造及銷售的發展情况，在制度推行的進程上有一定的異同。 第二部分，透過文献分析、比较研究等方法瞭解目前國際上在執行藥物不良反通報系統普遍所遇到的問题與困難。其主要包括自報告監察方式存在局限性、報告的處理方法未統一、醫務人员認知不足和專業人才的欠缺等。 第二部分,透過專家訪谈和實地考察的辦法探討在澳門推行藥物不良反應通報将會遇到的問题和困難並提出解决方案及策略。 第四部分，綜合前述部份總結的资料和經驗，構建適合澳門地區藥物不良反應通報系统模型。 關鍵詞:藥物安全性監测 藥物不良反愿 自發報告