我國實施中藥優良藥品製造標準政策之研究

Abstract

本研究以原創概念將我國實施中藥優良藥品製造標準(GMP)政策之經驗以濃縮製劑（1982-1988）、傳統製劑（1989-2005）及原料藥（2006-2009）分為三階段，描述其由來與變遷並以系統理論模型加以評析，強調各階段之系統所面臨的環境以及決策者所為之政策因應。在論文結構上，本論文第一章為緒論，分節說明研究背景與研究目的、研究途徑及研究方法、相關文獻探討、章節安排。論文主體首先介紹我國藥政大要及衛生署建構中藥用藥安全環境計畫（第二章），然後針對政策的現況詳為說明（第三章）。然後則是關注變遷中之政經所帶來的影響，尤其全球化及兩岸恢復制度化協商對我國實施中藥優良藥品製造標準的影響，其中也包括外國的發展（第四章）。之後將藉由不同階段推動實施中藥GMP經驗之歸納與整理，提出我國的制度興革意見（第五章），最後則是結論與建議（第六章）。本研究認為：（一）我國在中藥濃縮製劑及中藥傳統製劑廠成功地全面實施GMP及後續管理119家GMP中藥廠之經驗，可供世界參考；至於中藥原料藥之管理雖已有初步成果，包括：中藥材包裝標示及公告限量標準，以及對單味中藥粉末進行查驗登記之管理；惟應加強源頭管理，並對中藥材（飲片）製備實施GMP管理才能事半功倍。（二）以系統理論研究我國實施中藥優良藥品製造標準之公共政策應屬可行，惟歷任衛生署署長及衛生署中醫藥委員會主任委員之領導風格及人格特質亦十分關鍵，學者可就中藥之重要公共政策決策模式進一步探討。本研究建議：（一）完備中藥材之源頭管理機制，包括進口產品文書認證及相關品質查核等，需透過兩岸共同合作。（二）宜在已建立『國外藥廠查核機制』及『衛生署受理國外藥廠實地查核申請作業事宜』的基礎上，研議及協商赴大陸進行藥廠實地稽查作業的方式。（三）我國應在確保中藥產業權益之前題下，就兩岸中藥相關法規協和化及相互認證機制等議題加以協商，並研議簽訂兩岸中藥用藥安全協議。

This study focuses on the creative concept of the implementation for Chinese medicine GMP in Taiwan through three stages: concentrated preparations (1982-1988), traditional preparations (1989-2005), medicine ingredients (2006-2009). We describe the origin and changes of the policy and systematically analyses it, emphasizing the environment present at each stage of the system and the corresponding policy response of the policymaker. As for the structure of this paper, the first Chapter is an introduction separately explaining the background, objectives, path and methodology of the study, investigating related documents, and laying out the different parts of the paper. The body of the paper then introduces the main points of the medicinal policy in Taiwan and the planning of the safety environment for the use of Chinese medicine within the structure of the Department of Health (Chapter 2), then follows a detailed explanation of the present state of the policy (Chapter 3). We then focus on the impact brought on by the political and economic changes, particularly the impact of globalization and the restoration of normalized relations across the Taiwan Strait on the implementation in Taiwan of the GMP standard policy for Chinese medicine, including developments overseas (Chapter 4). Thereafter, using induction and collation of experiences resulting from the promotion and implementation of various stages of GMP for Chinese medicine, we provide opinions from Taiwan on this system and reform (Chapter 5), we then conclude and make recommendations (Chapter 6). In this study, we believe that (1) the successful experience of Taiwan in the total implementation of GMP for Chinese medicine concentrated preparations and traditional preparations and the subsequent management of 119 GMP Chinese medicine factories can serve as a reference worldwide, as for the management of Chinese medicine raw materials, although there already are some results, including standards for labeling packages and publishing maximal quantities as well as management of single ingredient Chinese medicine powder not subject to inspection and registration, upstream management needs to be strengthened and manufacturing equipment for Chinese medicine ingredients must be managed under the GMP program in order to increase its effectiveness. (2) It is possible the systematically analyze the public policies used in Taiwan to implement standards for Chinese medicine GMP, the personalities and leadership styles of past and present Directors of the Department of Health and of the Committee on Chinese Medicine and Pharmacy were key to this success, scholars can further discuss the modus operandi for important public policy decisions concerning Chinese medicine. The recommendations of this study are as follows: (1) Completing the upstream management system for Chinese medicine ingredients, including certification of imported product documentation and related quality checks, cooperation between both sides of the Taiwan Strait is necessary. (2) Studying and discussing the methods for onsite inspections of medicine factories in China, on the basis of the already-existing 'Mechanism for inspection of foreign-based medicine factories' and 'Regulations concerning the acceptance by the DOH of applications for inspection of foreign-based medicine factories'. (3) Under the precondition of preserving the rights of the domestic drug industry, agreements between the two sides of the Strait must be looked for on subjects such harmonization of medicine-related regulations and mechanisms for mutual certification, and the signing of a cross-trait agreement on Chinese medicine drug safety must be discussed.