我國藥品管制架構之初探

Abstract

快速的生技發展，與社會對健康照護的需求提高，使藥品產業成為新世紀中的重要產業。政府對於藥品的管制，主要目標是：安全、實效和效率。目前國內缺乏藥品管制的系統性學術研究，本文希望作為未來相關研究的起點，嘗試系統性的勾勒出我國目前的藥品管制架構，討論目前系統缺失，探究我國的管制哲學，使與國際研究接軌，並對未來發展提出建議。 首先，本文探討我國藥品管制機關的工作劃分，以及管制機關的權能。行政院衛生署的藥政處是目前主要的管制機關，中醫藥委員會、藥物食品檢驗局、財團法人醫藥品查驗中心、藥害救濟基金會等，都在不同的管制任務中負責部分業務。 本文以藥品進入市場的時間為軸，分為三大部分討論藥品管制：上市前管制、製造與販賣管制、上市後監督管制。上市前管制包括：新藥、學名藥、中草藥的上市前審查機制，以及對臨床試驗的規範。製造與販賣管制包括：優良藥品製造規範的推動，和藥商、藥局的管理。上市後監督管制包含：藥品不良反應通報機制、藥害救濟基金、廣告與促銷的管制和藥品品質檢驗。 對於未來藥品管制的發展，本文建議：應尋求國際合作，尤其是區域性的合作，以節省管制成本；進而提昇上市後管制的資源比重，使藥品管制更具效率。關於將來藥品管制機關的重構，不應僅以美國為師，應考量我國的醫療文化，並改革目前科學領導的科技政策決策機制，引入審議民主參與的機制。

As the fast development of biotechnology and the increasing demand of health care have made the drug industry a promising one in the new century, the governmental interests in building a drug regulatory system grow. For the government, the goals of drug regulation are safety, efficacy, and efficiency. Due to the lack of related studies in Taiwan, this thesis aims to systematically draw the picture of current regulation, point out potential problems, and make suggestions. First, the thesis glances at the structure and capacity of drug regulatory agency (DRA) in Taiwan. The main DRA is the Bureau of Pharmaceutical Affairs, the Department of Health. In addition, the Committee of Chinese Herbal Medicine, the Bureau of Food and Drug Analysis, the Center For Drug Evaluation, and Taiwan Drug Relief Foundation all contribute in different stage of regulation. The thesis introduces the regulation by the timely order of how a drug enters the market. In the first part, pre-market regulation, the registration of new drugs, generic drugs, and Chinese herbal medicine are discussed as well as the regulation of clinical trials. Followed is the analysis of regulation of manufacturing and distribution, including good manufacturing practice and the management of dealers and pharmacy. In the third part, the Adverse Drug Reaction System, the Drug Relief Funds, the regulation of promotion and advertising, and quality control are summarized as the part of post-market surveillance. To the future of regulation, the author argues that the international harmonization and regional cooperation should be considered and the weight of post-market surveillance shall be raised. During the reconstruction of the DRA, the local therapeutic culture should be concerned as an important factor instead of merely copying foreign structures. And a more deliberate decision process should be introduced to mix with current science-leading process.