TBT協定之規範目的在於確保各國輸出品之品質、保護人類、動植物之生命或健康或環境、防止詐欺行為等目的，確保會員之技術性法規、標準以及符合性評估程序，不致對國際貿易造成不必要之障礙。為促進國際貿易之順暢，調和各國分歧的技術規章或標準有其必要性，TBT協定第2.4條要求會員應以相關國際標準作為其技術性措施之依據，以避免造成不必要之國際貿易障礙，但條文中並未明確定義何謂國際標準。特別是牽涉到人類健康、安全的醫藥產品，因其特殊性，此類產品與其製程向來受到各國政府高度管制，各國在藥品跨國輸入時，所面臨的技術性法規往往不一致，因此便有呼籲發起調和國際間規範落差之國際倡議，國際醫藥法規協合組織的成立便受到重視。
我國衛生福利部食品藥物管理署於2014年12月22日公告一份「國際醫藥法規協合組織（ICH）規範採認清單」，為與國際藥品審查標準接軌，我國爰引ICH之指導原則制定出此份規範採認清單。假若其他WTO會員國對於我國的藥品制度產生合法性爭議時，我國衛生福利部基於ICH所制定的指導原則，是否符合TBT協定下第2.4條的國際標準，更進一步言之，ICH所通過的指導原則是否符合TBT協定下第2.4條的國際標準。本文將從TBT協定相關條文、TBT委員會相關決議、爭端解決機構所通過的小組及上訴機構報告、ICH官方資料等進行研究，分析TBT協定第2.4條下之國際標準之構成要件，以及ICH指導原則與TBT協定下的國際標準之合致性。若未來我國面臨此類議題時，希冀能提供相關建議及參考。　

The purpose of the Agreement on Technical Barriers to Trade is to ensure the quality of its exports, or for the protection of human, animal or plant life or health, of the environment, of for the prevention of deceptive practices and to ensure that technical regulations and standards and procedures of assessment of conformity do not create unnecessary obstacles to international trade. In order to facilitate the conduct of international trade, Articles 2.4 of TBT agreement require WTO members shall use relevant international standard, or the relevant part of them, as a basis for the technical regulations. However, the term "international standard" is not defined under the TBT Agreement.Because the particularity of pharmaceutical products for human use, such products and its process has always been highly regulated by the governments. On account of the divergence in technical requirements of new medicinal products from country to country. The urgent need to rationalise and harmonise regulation was impelled by concerns. Thus, the authorities of various countries discuss a joint regulatory-industry initiative on international harmonisation, and ICH was conceived. The establishment of the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use has received considerable critical attention.
To be more actively involved in ICH’s harmonisation work, our government has developed the specification checklist according to the ICH guidelines in recent years. If one day the member of WTO requested the establishment of a panel, considering the legitimacy of our government’s regulation.Whether our government regulations, according to the ICH guideline, are inconsistent with Article 2.4 of the TBT Agreement. Furthermore, whether the alleged ICH guidelines was indeed a "relevant international standard" within the meaning of Article 2.4. This essay tries to analysis
the elements constitutes a "international standard" for the purposes of Article 2.4 and whether the ICH guidelines are consistent with Article 2.4 of the TBT Agreement, based on the relevant article wording, decision made by TBT committee, DSB decisions , Official report from ICH and so on. Finally, this essay offer suggestions for future directions.

目錄
第一章 緒論 1
第一節 研究動機與目的 1
第二節 研究方法、範圍 2
第一項 研究方法 2
第二項 研究範圍 2
第三節、論文架構 3
第二章 TBT協定下國際標準組織之構成要件 4
第一節TBT協定下的國際標準 4
第一項 TBT協定下技術性法規、標準及符合性評估程序之概述 5
第二節TBT委員會對於國際標準組織之決議 10
第一項TBT委員會1999年國際標準組織之提案 11
第二項TBT委員會2015年之決議 11
第三項 TBT委員會之決議於WTO DSB案例中之援引或適用 13
第三節TBT協定下國際標準組織之爭端解決案例 14
第一項 以歐盟沙丁魚案為例 14
第二項 以美國鮪魚案II為例 16
第三項 以美國肉品原產地標示案為例 22
第四項 分析 23
第三章 國際醫藥法規協合組織 26
第一節 國際醫藥法規協合組織歷史概述 26
第二節 國際醫藥法規協合組織介紹 30
第一項 國際醫藥法規協合組織簡介 30
第二項 會員種類及資格 31
第三項 觀察員種類及資格 36
第四項 ICH組織架構及職權 40
第三節 國際醫藥法規協合組織調和程序及成果 48
第一項 調和程序 48
第二項ICH調和成果 54
第四章 ICH指導原則與TBT協定下的國際標準之合致性 58
第一節 國際醫藥法規協合組織（ICH）指導原則Q5C 59
第一項 國際醫藥法規協合組織（ICH）指導原則Q5C概述 59
第二項 衛生福利部藥品安全性試驗基準概述 60
第二節 ICH 指導原則Q5C 是否屬於TBT協定下之國際標準 62
第一項 系爭指導原則是否屬於TBT協定第2.4條下的「標準」 62
第二項 系爭指導原則是否由國際標準化組織所通過 64
第三項 系爭指導原則是否公諸於眾 68
第三節 ICH 之調和程序與TBT委員會2015年決議六項原則之合致性 68
第一項 透明性 69
第二項 公開性 70
第三項 公正性和基於共識 70
第四項 有效性與相關性 71
第五項 一致性 72
第六項 發展面向（Development Dimension） 72
第七項 小結 73
第四節 結論 74
第五章 結論 77
論文參考文獻 83 

論文參考文獻
壹、中文
一、專書
1.羅昌發，國際貿易法，2版，2010。
2.林彩瑜，WTO制度與實務，2版，2013。
3.洪德欽，WTO法律與政策專題研究，2版，2002年。

二、期刊論文
1. 牛惠之，WTO技術性貿易障礙（TBT）協定就安全貿易之適用與限制──環保標示、GMO 標示之評析，政大法學評論，第95期，2007年。
2. 倪貴榮，國際食品安全委員會(Codex)在國際貿易體系之地位──探討作為WTO國際標準之正當性，收錄於：歐盟與美國生物科技政策，2013年。
3. 莊涵因，技術性法規?─初步評析TBT協定是否適用於歐盟化妝品動物實驗禁令，貿易政策論叢，20期，2013年。

三、學術論文
1. 陳在方，世界貿易組織爭端解決機制下舉證責任之研究，國立臺灣大學法律學研究所碩士論文（2005）。
2. 陳以昕，TBT協定下「國際標準」之適當解釋與運用─兼論與菸草控制框架公約規範體系之可能連結，國立臺灣大學法律學院法律學系碩士論文（2015）。

四、研究資料（政府報告）
1.行政院衛生福利部食品藥物署，國際醫藥法規協合組織(ICH)規範採認清單公告函文， 2014年12月22日，網址: http://www.fda.gov.tw:8080/tc/siteListContent.aspx?sid=2984&id=9996&chk=b86ef33b-6b6d-4c33-8d34-9a58186c306e¶m=pn%3D2%26sid%3D2984#.WZPtsVUjHX4
2. 行政院衛生福利部食品藥物署，藥品臨床試驗計畫-技術性文件指引，2015年10月，網
址:http://www.ncku.edu.tw/nckuhirb/upload/news_rpt/2015110218111986477.pdf
3. 經濟部中小企業處南港生技育成中心，NBIC 生技法規資料庫。

五、網際網路
1. 懷孕用藥安全，臺大醫院健康電子報，018期，2009年5月，網址:
http://epaper.ntuh.gov.tw/health/200905/health.html
2.美下市普帕西芬 衛署評估，中華民國製藥發展協會，2010年10月20日，，網址: http://www.cpmda.org.tw/news_show_n1.php?news_id=783
3.楊宗樺藥師，Thalidomide，早安台灣專業醫藥諮詢網，2011年2月21日,網址: http://www.ohayoo.com.tw/Thalidomide.htm
4. 林麗文，生物技術產品之上市審查，生物資訊核心實驗室，2003年，網址: http://bc.imb.sinica.edu.tw/images/biotech/31_35.pdf

貳、英文部分
一、專書
1. GRANDOMICHELLE T., EVIDENCE, PROOF, AND FACT-FINDING IN WTO DISPUTE SETTLEMENT (2009).
2. LUKASZ GRUSZCZYNSKI, REGULATING HEALTH AND ENVIRONMENTAL RISKS UNDER WTO LAW: A CRITICAL ANALYSIS OF THE SPS AGREEMENT, (2010).
3.MITSUO MATSUSHITA, MITSUO MATSUSHITA& PETROS C. MAVROIDIS, THE WORLD TRADE ORGANIZATION: LAW, PRACTICE, AND POLICY, (2003).
4. MICHAEL TREBILCOCK & TRACEY EPPS, RESEARCH HANDBOOK ON THE WTO AND TBT AGREEMENT, (Michael Trebilcock & Tracey Epps, eds, 2013).
5. PALMETER DAVID & PETROS C. MAVROIDIS, DISPUTE SETTLEMENT IN THE WORLD TRADE ORGANIZATION: PRACTICE AND PROCEDURE, (2004).
6. SCHEPEL HARM,THE CONSTITUTION OF PRIVATE GOVERNANCE PRODUCT STANDARDS IN THE REGULATION OF INTEGRATING MARKETS,(2005).
7. Schroder Humberto Zúñiga, HARMONIZATION, EQUIVALENCE AND MUTUAL RECOGNITION OF STANDARDS IN WTO LAW,(2011).
8. WOLFRUM RÜDIGER, PETER-TOBIAS STOLL, ANJA SEIBERT-FOHR&
MARTINUS NIJHOFF PUBLISHERS,WTO: Technical Barriers And Sps Measures,(2007).

二、期刊論文與研究報告
1. Appleton Arthur E., The Agreement on Technical Barriers to Trade, in THE WORLD TRADE ORGANIZATION: LEGAL, ECONOMIC AND POLITICAL ANALYSIS(2005).
2. Appleton Arthur E., &Veijo Heiskanen, The sardines decision: Fish without chips?, in CHALLENGES AND PROSPECTS FOR THE WTO (2005).
3. Barceló III John J., Burden of Proof, Prima Facie Case and Presumption in WTO Dispute Settlement, 42 CORNELL INTERNATIONAL LAW JOURNAL 1, (2009).
4. Büthe Tim &Walter Mattli, Private Regulator in Global Market : Institutional Structure and Complementary in Product Regulation, in THE NEW GLOBAL RULES :THE PRIVATIZATION OF REGULATION IN THE WORLD ECONOMY, (2001).
5. Delimatsis Panagiotis,‘Relevant International Standards’ and ‘Recognized Standardization Bodies’ under the TBT Agreement, TILEC DISCUSSION PAPER,(2014).
6. Du Michael M., Reducing Product Standards Heterogeneity through International Standards in the WTO: How Far across the River, 44 J. WORLD TRADE 295, (2010).
7. Eakin, M.D David V., The International Conference on Harmonization of Pharmaceutical Regulations, the European Medicines Evaluation Agency, and the FDA: Who's Zooming Who?, 6 TULSA JOURNAL OF COMPARATIVE & INTERNATIONAL LAW, (1999).
8. Erik Wijkström, Devin McDaniels, Improving Regulatory Governance: International Standards and the WTO TBT Agreement, 47 (5) JOURNAL OF WORLD TRADE,(2013).
9. Esber Amelia A., Curing the Drug Lag: A Proposal for International Harmonization of Pharmaceutical Approval,31 ARIZONA JOURNAL OF INTERNATIONAL AND COMPARATIVE LAW,(2014).
10. Fontanelli, Filippo, ISO and Codex Standards and International Trade Law : What Gets Said is Not What's Heard, 60 International and Comparative Law Quarterly
11. Glinski Carola, Private Norms as International Standards?-Regime Collisions in Tuna—Dolphin II, 4, EUR.J.RISK.REG. (2012).
12. Horn Henrik and Joseph H. H. Weiler, European Communities – Trade Description of Sardines: Textualism and its Discontent, in THE WTO CASE LAW OF 2002, (2005).
13. Horn Henrik, Petros C. Mavroidis & Erik Wijkström, In the Shadow of the DSU: Addressing Specific Trade Concerns in the WTO SPS and TBT Committees, COLUMBIA LAW AND ECONOMICS WORKING PAPER NO. 494,(2013).
14. Howse Robert, A new device for creating international legal normativity : the WTO technical barriers to trade agreement and "international standards", CONSTITUTIONALISM, MULTILEVEL TRADE GOVERNANCE AND SOCIAL REGULATION, (2006).
15.Howse Robert& Elisabeth Tuerk, The WTO Impact on Internal. Regulations—A Case Study of the. Canada–EC Asbestos Dispute, in TRADE AND HUMAN HEALTH AND SAFETY 77,(2006).
16. Howse Robert, The Sardines Panel and AB Rulings–Some Preliminary Reactions,29(3) LEAGAL ISSUES OF ECON.INTEGRATION 247,(2002).
17. Howse Robert, A new device for creating international legal normativity : the WTO technical barriers to trade agreement and "international standards, in CONSTITUTIONALISM, MULTILEVEL TRADE GOVERNANCE AND SOCIAL REGULATION,(2006).
18. Joerges Christian, Free Trade with Hazardous Products? The Emergence of Transnational Governance with Eroding State Government, EUI WORKING PAPER LAW NO. 2006/05,(2006).
19.Joshi Manjoi, Are eco-labels consistent with World Trade Organization agreements?, 38(1)JOURNAL OF WORLD TRADE 69,(2004).
20. Kanusky Rosemarie, Harmonizing Pharmaceutical Regulation Among the United States,the European Union, and Japan: The ICH Initiative,HOUSTON JOURNAL OF INTERNATIONAL LAW,(1994).　
21. Kidd Dan, The International Conference on Harmonization of Pharmaceutical Regulations, the European Medicines Evaluation Agency, and the FDA: Who's Zooming Who, Global Legal Studies Journal, Vol. 4, No. 1, (1996).
22. Kurtz Jürgen, A Look Behind the Mirror: Standardisation, Institutions and the WTO SPS and TBT Agreements, 30 (2) UNIVERSITY OF NSW LAW JOURNAL, (2007).
23. Livermore Michael A., Authority and Legitimacy in Global Governance: Deliberation, Institutional Differentiation, and the Codex Alimentarius, 81 NEW YORK UNIVERSITY LAW REVIEW, (2006).
24. Marceau Gabrielle& Joel P. Trachtman,A Map of the World Trade Organization Law of Domestic Regulation of Goods: The Technical Barriers to Trade Agreement, the Sanitary and Phytosanitary Measures Agreement, and the General Agreement on Tariffs and Trade, 48 JOURNAL OF WORLD TRADE, ISSUE 2, (2014).
25. Mathis James H.,The WTO Agreement on Technical Barriers to Trade,16(1) CONSUNER POLICY REVIEW14,(2006).
26. Mattli Walter&Tim Büthe,Setting International Standards : Technical Rationlity or Primacy of Power? , 56(1)WORLD POLITICS1, (2003).
27 Merrill Richard A., Regulation of drugs and devices: An evolution, HEALTH AFFAIRS 13, no. 3 (1994).
28. Mcdonald Jan, Domestic regulation, international standards, and technical barriers to trade,4(2), World Trade Review, (2005).
29. Meltzer Joshua,State Sovereignty and the Legitimacy of the WTO, 26(4) UNIVERSITY OF PENNSYLVANIA JOURNAL OF INTERNATIONAL LAW 693,(2005).
30. Motaal Doaa Abdel, The Agreement on Technical Barriers to Trade, the Committee on Trade and Environment, and Eco-labeling, in TRADE, ENVIRONMENT, AND THE MILLENNIUM (Gary P. Sampson & W. Bradnee Chambers eds., 1999).
4,(2011) .
31. Pauwelyn Joost, The Use of Experts in WTO Dispute Settlement, 51(2) INTERNATIONAL AND COMPARATIVE LAW QUARTERLY,(2006).
32. Pauwelyn Joost, Wessel Ramses, and Wouters Jan, Informal International Lawmaking: An Assessment and Template to Keep It Both Effective and Accountable, in INFORMAL INTERNATIONAL LAWMAKING, (2012).
33. Petros C. Mavroidis & Erik N. Wijkström, Moving out of the shadows: Bringing transparency to standards and regulations in the WTO's TBT Committee, in RESEARCH HANDBOOK ON THE WTO AND TECHNICAL BARRIERS TO TRADE, (2013).
34. Roht-Arriaza Naomi, Shifting the Point of Regulation: The International Organization for Standardization and Global Lawmaking on Trade and the Environment, 22 ECOLOGY LAW QUARTERLY 479, (1995).
35. Rosman Lewis, Public Participation in International Pesticide Regulation: When the Codex Commission Decides, Who Will Listen?, 12 VIRGINIA ENVIRONMENTAL LAW JOURNAL 329,(1993).
36. Schepel, Harm,The Empire's Drains: Sources of Legal Recognition of Private Standardisation under the TBT Agreement, Constitutionalism, in MULTILEVEL TRADE GOVERNANCE AND SOCIAL REGULATION 397,(2006).
37. Scott Joanne, International Trade and Environmental Governance: Relating Rules (and Standards) in the EU and the WTO,15 (2) EUROPEAN JOURNAL OF INTERNATIONAL LAW,(2004).
38.Stewart Richard B.& Michelle Ratton Sanchez Badin, The World Trade Organization and Global Administrative Law, NYU SCHOOL OF LAW, PUBLIC LAW RESEARCH PAPER NO. 09-71, (2009).
39. Tuffs Annette, Thalidomide: the true story? BRITISH MEDICAL JOURNAL, 2007.
40. Veijo Heiskanen, The Regulatory Philosophy of International Trade Law, 38(1)JOURNAL OF WORLD TRADE, (2004).
41. Wagner Markus, International Standards in Research Handbook on the WTO and TBT Agreement, (Michael Trebilcock & Tracey Epps, eds, 2013).
42. Wallach Lori M., Accountable Governance in the Era of Globalization: The WTO, NAFTA, and International Harmonization of Standards, 50 UNIVERSITY OF KANSAS LAW REVIEW 823,(2002).
43. Winn Jane K.,Globalization and Standards: The Logic of Two-Level Games, I/S: JOURNAL OF LAW AND POLICY FOR THE INFORMATION SOCIETY, (2009).



三、官方文件
1. United States Trade Representative ,TPP Full Text, (Nov. 5, 2015
2. U.S. Food and Drug Administration, Volume IV - 3.2 Historical Background and Law,http://www.fda.gov/scienceresearch/fieldscience/laboratorymanual/ucm171972.htm；
3. The International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use, Articles of Association. (May. 31, 2017).
4. ICH Harmonised Tripartite Guideline, Quality of Biotechnological Products: Stability Testing of Biotechnological/ Biological Products Q5C, (Nov. 30, 1995).
5. Council Regulation (EEC) No.2136/89, (adoped on 21 Jun.1989).
6. European Medicines Agency, Note for Guidance on Quality of Biotechnological Products: Viral Safety Evaluation of Biotechnological Products Derived from Cell Lines of Human or Animal Origin, (CPMP/ICH/295/95) (Oct, 1997).

四、網路資料
1.U.S Introduction to Proposed TBT Annexes on Medical Devices,
Pharmaceutical Products and Cosmetic Products, from http://www.citizenstrade.org/ctc/wp-content/uploads/2011/10/TransPacificTBTwMedicalAnnexes.pdf
2. U.S. FOOD AND DRUG ADMINISTRATION, This Week in FDA History, from http://www.fda.gov/aboutfda/whatwedo/history/thisweek/ucm117836.htm
3. The International Council for Harmonisation(ICH) ,The Need to Harmonise, from http://www.ich.org/about/history.html.
4. The International Council for Harmonisation(ICH) , Initiation of ICH, from http://www.ich.org/about/history.html
5. The International Council for Harmonisation(ICH) ,The Evolution of ICH,from http://www.ich.org/about/history.html
6. The International Council for Harmonisation(ICH) ,Organisational-Changes, from http://www.ich.org/about/organisational-changes.html
7. The International Council for Harmonisation(ICH) ,Organisation, from http://www.ich.org/about/organisation-of-ich/assembly/pandrh/organisation.html
8. The International Council for Harmonisation(ICH) ,Membership, from http://www.ich.org/about/membership.html
9. The International Council for Harmonisation(ICH),The revised ICH Articles of Association, Rules of Procedure and Standard Operating Procedures are now available on ICH, from http://www.ich.org/ichnews/newsroom/read/article/the-revised-ich-articles-of-association-rules-of-procedure-and-standard-operating-procedures-are-no.html
10. The International Council for Harmonisation(ICH), Organisation of ICH, from http://www.ich.org/about/organisation-of-ich.html
11. The International Council for Harmonisation(ICH), Assembly, from http://www.ich.org/about/organisation-of-ich/assembly.html
12. The International Council for Harmonisation(ICH), MedDRA Management Committee, from
http://www.ich.org/about/organisation-of-ich/meddra.html
13. The International Council for Harmonisation(ICH) ,Secretariat, from http://www.ich.org/about/organisation-of-ich/secretariat.html
14. . The International Council for Harmonisation(ICH) ,Working-Groups, from
http://www.ich.org/about/organisation-of-ich/working-groups.html
15. The International Council for Harmonisation(ICH) ,Auditors, from http://www.ich.org/about/organisation-of-ich/auditors.html
16. The International Council for Harmonisation(ICH) ,Process of Harmonisation, from
http://www.ich.org/products/process-of-harmonisation.html
17. The International Council for Harmonisation(ICH) , Formal ICH Procedure, from
http://www.ich.org/products/process-of-harmonisation/formalproc.html#step-1.
18. The International Council for Harmonisation(ICH), Q&A Procedure, , from
http://www.ich.org/products/process-of-harmonisation/qa-procedure.html.
19. The International Council for Harmonisation(ICH), Revision Procedure, from http://www.ich.org/products/process-of-harmonisation/revision-procedure.html
20. The International Council for Harmonisation(ICH),Maintenance Procedure, from HARMONISATION(ICH),http://www.ich.org/products/process-of-harmonisation/maintenance-procedure.html.
21. The International Council for Harmonisation(ICH), Quality Guidelines, from http://www.ich.org/products/guidelines/quality/article/quality-guidelines.html
22. The International Council for Harmonisation(ICH), Efficacy Guidelines, from http://www.ich.org/products/guidelines/efficacy/article/efficacy-guidelines.html
23 The International Council for Harmonisation(ICH),Safety Guidelines, from http://www.ich.org/products/guidelines/safety/article/safety-guidelines.html
24. The International Council for Harmonisation(ICH),Multidisciplinary Guidelines, from
http://www.ich.org/products/guidelines/multidisciplinary/article/multidisciplinary-guidelines.html
25. The International Council for Harmonisation(ICH), ICH Steering Committee, Minneapoli, MN, USA, June. 2014, July.8, 2014, from
http://www.ich.org/ichnews/newsroom/read/article/ich-steering-committee-minneapolis-mn-usa-june-2014.html

五、WTO小組報告
1. Panel Reports, European Communities — Measures Affecting the Approval and Marketing of Biotech Products, WT/DS291/R, WT/DS292/R, WT/DS293/R (Sep. 29, 2006).
2. Panel Report, European Communities — Trade Description of Sardines, WT/DS231/R (May 29, 2002).
3. Panel Reports, India — Quantitative Restrictions on Imports of Agricultural, Textile and Industrial Products,WT/DS90/R (Apr. 6, 1999).
4. Panel Reports, United States－Certain Country of Origin Labelling (COOL) Requirements, WT/DS384/R, WT/DS386/R (Nov. 18, 2011).
5. Panel Report, United States — Measures Concerning the Importation, Marketing and Sale of Tuna and Tuna Product), WT/DS381/R (Sept.15, 2011).
6. Panel Reports, United States — Section 110(5) of US Copyright Act,WT/DS160/R (June. 15, 2000).

六、WTO上訴機構報告
1. Appellate Body Report, European Communities — Measures Affecting Asbestos and Products Containing Asbestos, WT/DS135/AB/R (Mar. 12, 2001).
2. Appellate Body Report, European Communities — Measures Prohibiting the Importation and Marketing of Seal Products, WT/DS400/AB/R, WT/DS401/AB/R (May. 22, 2014).
3. Appellate Body Report, European Communities — Trade Description of Sardines, WT/DS231/AB/R (Sep 26, 2002).
4. Appellate Body Report, Japan — Taxes on Alcoholic Beverages, WT/DS10/AB/R, WT/DS11/AB/R (Oct. 4, 1996).
5.Appellate Body Report, United States－Certain Country of Origin Labelling (COOL) Requirements, WT/DS384/AB/R, WT/DS386/R (June. 29, 2012).
6. Appellate Body Report, United States — Import Prohibition of Certain Shrimp and Shrimp Products, WT/DS58/AB/R (Oct. 12, 1998).
7. Appellate Body Report, United States — Measures Affecting the Production and Sale of Clove Cigarettes, WT/DS406/AB/R (Apr. 4, 2012).
8. Appellate Body Report, United States — Measures Concerning the Importation, Marketing and Sale of Tuna and Tuna Product), WT/DS381/AB/R (May. 16, 2012).

七、WTO其他文件
1.Codex, Codex Members and Observers, CODEX,(Aug.18, 2016)
2. International Organization for Standardization and International Electrotechnical Commission, ISO/ IEC Directives, Part 1(2015).
3. International Organization for Standardization and International Electrotechnical Commission, ISO/ IEC Guide 2:1991 Standardization and related activities General Vocabulary, (1991).
4. International Organization for Standardization and International Electrotechnical Commission, ISO/ IEC Guide 2:2004 Standardization and related activities General Vocabulary, (2004).
5. World Health Organization, The Impact of Implementation of ICH Guidelines in Non-ICH Countries, WHO/EDM/QSM/2002.3 (Sept.13-15, 2001).
6. WTO, Committee on Trade and Environment & Committee on Technical Barriers to Trade, Communication from Canada, WT/CTE/W/21, G/TBT/W/21 (Feb. 21, 1996).
7.WTO, Committee on Technical Barriers to Trade, Decisions and Recommendations Adopted by the WTO Committee on Technical Barriers to Trade Since 1 January 1995, G/TBT/1/Rev.12 (Jan. 21, 2015).
8.WTO, Committee on Technical Barriers to Trade, List of International Standardizing Bodies for Purposes of Article10.4 and 13.3 of the Agreement, TBT/w/8 (June. 5, 1980).
9. WTO, Committee on Trade and Environment & Committee on Technical Barriers to Trade, Marking and Labelling Requirements, WT/CTE/W/192, G/TBT/W/162 (June. 19, 2001).
10. WTO, Committee on Technical Barriers to Trade, Minutes of the Meeting of 2 November 2005, G/TBT/M/37(Dec. 22, 2005).
11.WTO, Committee on Trade and Environment & Committee on Technical Barriersto Trade, Negotiating History of the Coverage of the Agreement on Technical Barriers to Trade with Regard to Labeling Reguirements,Voluntary Standards, and Processes and Production Methods Unrelated to Product Characteristics, WT/CTE/W/10,G/TBT/W/11 (Aug. 29, 1995).
12. WTO, Committee on Technical Barriers to Trade, On the Conditions for Acceptance and Use of International Standards in the Context of the WTO Technical Barriers to Trade Agreement, G/TBT/W/87 (Sept. 14, 1998).
13.WTO, Committee on Technical Barriers to Trade, On the Conditions for Acceptance and Use of International Standards in the Context of the WTO Technical Barriers to Trade Agreement, G/TBT/W/87/Rev.1 (Sep. 30, 1999).
14.WTO, Committee on Technical Barriers to Trade, Second Triennial Review of the Operation and Implementation of the Agreement on Technical Barriers to Trade, G/TBT/9 (Nov. 13, 2000).