Policy research on the implementation of Good Manufacturing Practice for Chinese Medicine in Taiwan
Date Issued
2009
Date
2009
Author(s)
Lin, I-Hsin
Abstract
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.
Subjects
CHINESE MEDICINE
GOOD MANUFACTURING PRACTICE
SYSTEM THEORY
MID-TERM PROGRAM
PREPARATION
MEDICINE INGREDIENT
Type
thesis
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