Macao is a miniature economic city with a terrestrial area of 27.3km' and a population of 448.000. Current pharmaceutical laws and regulations of Macao have been inherited from its colonial Portuguese past for over 400 years. As a consequence of limited financial and professional human resources, Macao currently encounters a great obstacle regarding implementation of a comprehensive drug regulatory system similar to such a kind adopted by most other advanced countries. Certain loopholes within the drug administration in Macao were identified due to imperfections in drug legislation. After handover of the Macao government to China in 1999, the situation became even more complicated and consecutively aggravated long existing problems in drug regulation. Presently, Macao’s government is in a transition period of healthcare reformation including amendments of relevant laws applicable to pharmaceuticals, changes that are gradually being performed in order to establish a more mature drug regulatory system. Since imported drugs have covered 98% of the drug supply in Macao, strengthening of import drug regulatory control is one of the most important measures to be taken in order to guarantee safe use of drugs by the public. Having considered technical limitations on one hand as well as assuring consistent drug supply for the local market on the other hand, Macao's government not only had difficulties in implementing a sophisticated drug registration system, as it has been in effect in advanced countries, but also seemed not to be capable of performing comprehensive evaluation on safety and efficacy of imported drugs Quality,. safety, and efficacy are three major components of the pharmaceutical entity. Among them, quality is the prerequisite of the other two. To Macao, where imported drugs dominate the majority of the local market, strengthening of the drug quality assurance system becomes extremely important and absolutely necessary. For many years, World Health Organization(WHO) has developed a series of guidelines in assisting governments, especially those in developing countries with limited resources, to promote an effective functioning of national regulatory and control mechanisms. By studying relevant guidelines, Macao's government has to find a way to establish its own drug regulatory and legislative model that best suits to its current situation and future development. Major aspects of the first chapter of this thesis cover background, objective, and methodology of the study. Moreover, interpretation and limitations of the relevant terminology is also included. It has been stated that study of current drug regulatory and quality assurance systems is essential and should be commenced without any delay. Additionally, WHO guidelines are an invaluable source for development of these systems. The second chapter mainly discusses current drug legislation and regulatory authority in Macao by retrospective review of the available literature. The result indicates that Macao’s government has preliminarily developed a particular framework for its own drug regulation over a decade of experiments. However, present pharmaceutical laws need to be re-evaluated, modified, and enhanced because of their current limitations and some additional historical factors. The third chapter discusses and analyzes three aspects involved in Macao's drug regulation: pre-marketing drug quality assurance, drug quality assurance of post-marketing supply, and quality assurance of drug manufacturing in Macao. Analysis shows that Macao's drug quality assurance and monitoring systems have their own distinctive characteristics and have achieved a certain level of satisfaction. By comparison, the fourth chapter of the thesis compares the current situation of Macao's drug regulation with “WHO Guidelines for Developing National Drug Policy, Guiding Principles for Small National Drug Regulatory Authorities, and Regulation of Pharmaceuticals in Developing Countries Legal Issues and Approaches.” The results indicate that Macao has actually established a particular drug quality assurance system governed by relevant laws, basically complying with WHO guidelines. However, there is still lack of some essential elements to “immaculate” those relevant pharmaceutical laws. At the same time, there is an ongoing need to introduce new policies strengthening relevant drug regulatory activities. The fifth chapter mainly deals with existing problems encountered in the current drug quality assurance system by aspects on pharmaceutical laws, drug registration, quality analysis, professional pharmaceutical management, and measures on combating counterfeit drugs. By using SWOT analysis, we have finally come up with six suggestions to consolidate several current issues for future development of Macao's drug regulation, i.e. enhancement of pharmaceutical laws, introduction of a drug registration system, participating on “WHO Certification Scheme on the Quality of Pharmaceutical Products Moving in International Commerce,” establishment of drug quality control laboratories, setting up standards for drug analysis, and improving the quality of practice by the pharmaceutical profession, All these factors will act as essential components to provide necessary directions for future drug policy reformation. Key words: Macao, Drug Regulation, Pharmaceutical Laws, Drug, Quality Assurance

澳門是微型經濟地區，總面積共 27.3 平方公里，約 44.8萬人口。由於有 400 多年的殖民地歷史，使得現行的藥政管理法規带有葡萄牙殖民地色彩。由於财政资源和專業人員的缺乏，澳門末能全面實施大型國家所宣導的藥政管理模式，現行的藥政法規不健全導致監管上存有一定的漏洞。1999年澳門回歸中國後，形勢的改變使得問題越來越突出。目前澳門正處於醫療改革的過渡時期，澳門政府正在逐步推行對藥政相關法律法規的修改，不断求變以期建立一個完善的藥政監管系統。澳門的藥品 98%依賴於進口，所以加強進口藥品的管理是保證澳門市民用藥安全的重要手段。由於技術的限制以及爲了充分保證澳門地藥品的供應，使得行政當局目前難以採取大型國家所實施的全面的藥品註册制度，更不可能開展详細的藥品安全評價和藥效學評價。藥品的安全性、有效性和品質是藥品的三大屬性，其中品質更是安全性和有效性的前提，對於澳門這樣非常依賴藥品進口的地區來說，加强藥品的品質保證系統顯得尤爲重要，並且切合實際。 世界衛生組織(World Health Organization, WHO)多年來發佈了一系列藥政管理指引以幫助政府尤其是資源不足的發展中國家成立一個有效的藥品管理系統。参考這些指引，澳門必須根據自身情况和特點建立一套適合自身發展的藥政管理和立法體系。本論文的第一章，主要是介紹研究的背景、目的和方法，並對相關的術語做出闡述和規範，結果表明探討澳門的藥政管理體制及藥品品質保證系統是有必要且合時宜，WHO 的指引對澳門藥政管理的發展有参考價值。 本論文的第二章，主要是通過文獻研究的方法探討澳門現行的藥政管理法律系和機構設置，結果表明澳門藥政管理經過十餘年的發展，已經初步建立了有自身特色的管理體制，但是由於歷史的原因，加上澳門本身的局限性，相藥政法规需要進一步的完善和改良。 本論文的第三章，綜述和分析澳門藥政管理涉及的三個範疇：藥品上市前品質管制、市場藥品供應品質管制和藥品生產品質管制，結果表明澳門的藥品品質保系統具有自身的特殊性，已經取得了一定的成果。 本論文的第四章，主要通過比較研究的方法，將澳門的藥政管理現状與 WHO“國家藥物政策指引、小型國家藥政管理機構指引、發展中國家藥政監管的法律問题和措施”進行比较，結果表明澳門已經建立了自身的藥政管理體制，制訂了相關的藥政法規，基本上符合 WHO 指引的要求，但現有的藥物政策及立法仍然缺少必要的元素，需要進一步完善相關的法律法規，同時亦要引入新的政策，加強品監管活動。本論文第五章，主要探討澳門現行的藥品品質保系統中存在的問题，分別法律法規、藥品註冊制度、藥品檢驗、從業人員管理和打擊偽藥的措施五個方面進行探討。透過 SWOT 分釋方法，最終澳門末來的政展提出六項策略:完善藥政法律法規、引入藥品註冊制度、參與 WHO 國際貿易藥物製劑品質認證計劃、組建藥品檢驗所、建立藥品檢测標準和提升從業人員的業務水平，進一步加強澳門的藥品品質保證系統。 關鍵字：澳門 藥政管理蘖政法規 藥品 品質保證