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Previous Review of Taiwan's Existing Regulations on the Access to Bioloical Resources Next Introducing and analyzing the Scope and Benefits of the Regulation「Statute for Upgrading Industries」in The Biotechnology Industry in Taiwan

Taiwan Recent Regulatory Development- Promoting Biotech and New Pharmaceuticals Industry

Over the past twenty years, the Government has sought to cultivate the biopharmaceutical industry as one of the future major industry in Taiwan. Back in 1982, the Government has begun to regard biotechnology as a key technology in Technology Development Program, demonstrated that biotechnology is a vital technology in pursuit of future economic growth. Subsequently, the Government initiated national programs that incorporated biotechnology as a blueprint for future industrial development. In order to enhance our competitiveness and building an initial framework for the industry, The Executive Yuan has passed the Biotechnology Industry Promotion Plan. As the Government seeks to create future engines of growth by building an environment conducive for enterprise development, the Plan has been amended four times, and implemented measures focused on the following six areas: related law and regulations, R&D and applications, technology transfer and commercialization, personnel training, investment promotion and coordination, marketing information and marketing service.

In 2002, the Executive Yuan approved the Challenge 2008, a six-year national development plan, pointing out biotechnology industry as one of the Two Trillion, Twin Stars industries. The Government planned for future economic growth by benefiting through the attributes of the biotechnology: high-tech, high-reward and less pollution. Thus, since 1997 the Strategic Review Board (SRB) under the Executive Yuan Science and Technology Advisory Panel has taken action in coordinating government policies with industry comments to form a sound policy for the biotechnology industry.

Additionally, a well-established legal system for sufficient protection of intellectual property rights is the perquisite for building the industry, as the Government recognized the significance through amending and executing related laws and regulations. By stipulating data exclusivity and experimental use exception in the Pharmaceutical Affair Act, tax benefits provided in Statute for Upgrading Industries , Incentives for Production and R&D of Rare Disease Medicine, Incentives for Medical Technology Research and Development, provide funding measures in the Guidance of Reviewing Programs for Promoting Biotechnology Investment.

Clearly, the government has great expectation for the industry through establishing a favorable environment by carrying out these policies and revising outdated regulations. Thus, the Legislative Yuan has passed the “Act for The Development of Biotechnology and New Pharmaceuticals Industry” in June, 2007, and immediately took effect in July. The relevant laws and regulations became effective as well, driving the industry in conducting researches on new drugs and manufacturing new products, increasing sales and expanding the industry to meet an international level.

For a biopharmaceutical industry that requires long-term investment and costly R&D, incentive measures is vital to the industry’s survival before the product launches the market. Accordingly, this article will be introducing the recent important regulation that supports the biopharmaceutical industry in Taiwan, and analyzing the government’s policies.

Biotechnology is increasingly gaining global attention for its potential in building future economic growth and generating significant profits. In an effort to support the biotechnology industry in Taiwan, the Government has made a step forward by enacting the “Act for the Development of Biotech and New Pharmaceutical Industry”.

The biopharmaceutical industry is characterized as high-risk and high-reward, strong government support and a well-developed legal system plays a vital role from its establishment throughout the long term development. Therefore, the Act was enacted tailor to the Biotech and New Pharmaceutical Industry, primarily focuses on tax benefits, R&D activities, personnel recruitment and investment funding, in support of start-up companies and attracting a strong flow of funding worldwide.

To pave the way for promoting the biopharmaceutical industry and the Biotech and New Pharmaceutical Company, here the article will be introducing the incentive measures provided in the Act, and supporting development of the industry, demonstrating the efforts made by the Government to build a “Bio-tech Island”.

Reference

“Act for Development of Biotech and New Pharmaceutical Industry”, webpage of Law and Regulations Database of the Republic of China. 4 July, 2007. Ministry of Justice, Taiwan. 5 Nov. 2008 http://law.moj.gov.tw/Eng/Fnews/FnewsContent.asp?msgid=3180&msgType=en&keyword=undefined

※Taiwan Recent Regulatory Development- Promoting Biotech and New Pharmaceuticals Industry,STLI, https://stli.iii.org.tw/en/article-detail.aspx?no=105&tp=2&i=168&d=6136 (Date:2026/04/19)
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Previous Review of Taiwan's Existing Regulations on the Access to Bioloical Resources Next Introducing and analyzing the Scope and Benefits of the Regulation「Statute for Upgrading Industries」in The Biotechnology Industry in Taiwan
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Review of Taiwan's Existing Regulations on the Access to Bioloical Resources

The activities of accessing to Taiwan's biological resources can be governed within certain extent described as follows. 1 、 Certain Biological Resources Controlled by Regulations Taiwan's existing regulation empowers the government to control the access to biological resources within certain areas or specific species. The National Park Law, the Forestry Act, and the Cultural Heritage Preservation Act indicate that the management authority can control the access of animals and plants inside the National Park, the National Park Control Area, the recreational area, the historical monuments, special scenic area, or ecological protection area; forbid the logging of plants and resources within the necessary control area for logging and preserved forestry, or control the biological resources inside the natural preserved area. In terms of the scope of controlled resources, according to the guidance of the Wildlife Conservation Act and the Cultural Heritage Preservation Act, governmental management authority is entitled to forbid the public to access the general and protected wild animals and the plant and biological resources that are classified as natural monuments. To analyse the regulation from another viewpoint, any access to resources in areas and of species other than the listed, such as wild plants or microorganism, is not regulated. Therefore, in terms of scope, Taiwan's management of the access to biological resources has not covered the whole scope. 2 、 Access Permit and Entrance Permit Taiwan's current management of biological resources adopts two kinds of schemes: access permit scheme and entrance permit in specific areas. The permit allows management authority to have the power to grant and reject the collection, hunting, or other activities to access resources by people. This scheme is similar to the international standard. The current management system for the access to biological resources promoted by many countries and international organizations does not usually cover the guidance of entrance in specific areas. This is resulting from that the scope of the regulation about access applies for the whole nation. However, since Taiwan has not developed regulations specifically for the access of bio-research resources, the import/export regulations in the existing Wildlife Conservation Act, National Park Law, Forestry Act, and Cultural Heritage Preservation Act may provide certain help if these regulations be properly connected with the principle of access and benefit sharing model, so that they will help to urge people to share the research interests. 3 、 Special Treatments for Academic Research Purpose and Aborigines Comparing to the access for the purpose of business operation, Taiwan's regulations favour the research and development that contains collection and hunting for the purpose of academic researches. The regulation gives permits to the access to biological resources for the activities with nature of academic researches. For instance, the Wildlife Conservation Act, National Park Law, and theCultural Heritage Preservation Act allow the access of regulated biological resources, if the academic research unit obtains the permit, or simply inform the management authority. In addition, the access by the aborigines is also protected by the Forestry Act, Cultural Heritage Preservation Act, and the Aboriginal Basic Act. The aborigines have the right to freely access to biological resources such as plants, animals and fungi. 4 、 The Application of Prior Informed Consent (PIC) In topics of the access to and benefit sharing of biological resources, the PIC between parties of interests has been the focus of international regulation. Similarly, when Taiwan was establishing theAboriginal Basic Act, this regulation was included to protect the aborigines' rights to be consulted, to agree, to participate and to share the interests. This conforms to the objective of access and benefit sharing system. 5 、 To Research and Propose the Draft of Genetic Resources Act The existing Wildlife Conservation Act, National Park Law, Forestry Act,Cultural Heritage Preservation Act, Aboriginal Basic Act provide the regulation guidance to the management of the access to biological resources within certain scope. Comparing to the international system of access and benefit sharing, Taiwan's regulation covers only part of the international guidance. For instance, Taiwan has no regulation for the management of wild plants and micro-organism, so there is no regulation to confine the access to wild plants and microorganism. To enlarge the scope of management in terms of the access to Taiwan's biological resources, the government authority has authorize the related scholars to prepare the draft of Genetic Resources Act. The aim of the Genetic Resources Act is to establish the guidance of the access of genetic resources and the sharing of interests in order to preserve the genetic resources. The draft regulates that the bio-prospecting activity should be classified into business and academic, with the premise of not interfering the traditional usages. After classification, application of the permit should be conducted via either general or express process. During the permit application, the prospector, the management authority, and the owner of the prospected land should conclude an agreement jointly. In the event that the prospector wishes to apply for intellectual property rights, the prospector should disclose the origin of the genetic resources and provide the legally effective documents of obtaining these resources. In addition, a Biodiversity Fund should be established to manage the profits derived from genetic resources. The import/export of genetic resources should also be regulated. Violators should be fined.

Taiwan Planed Major Promoting Program for Biotechnology and Pharmaceutical Industry

Taiwan Government Lauched the “Biotechnology Action Plan” The Taiwan Government has planned to boost the support and develop local industries across the following six major sectors: biotechnology, tourism, health care, green energy, innovative culture and post-modern agriculture. As the biotechnology industry has reached its maturity by the promulgation of "Biotech and New Pharmaceutical Development Act" in July, 2007, it will be the first to take the lead among the above sectors. Thus, the Executive Yuan has launched the Biotechnology Action Plan as the first project in building the leading industry sectors, to upgrade local industries and stimulate future economic growth. Taiwan Government Planed to Promote the Biotechnology and Other newly Industries by Investing Two Hundred Billion To expand every industrial scale, enhance industrial value, increase the value around the main industrial field, and to encourage the industrial development by government investments for creating the civil working opportunities to reach the goal of continuous economic development, the Executive Yuan Economic Establishment commission has expressed that, the government has selected six newly industrials including "Biotechnology", "Green Energy", "Refined Agriculture", "Tourism", "Medicare", and "Culture Originality" on November 19, 2009 to promote our national economic growth. The government will invest two hundred billion NT dollars to support the industrial development aggressively and to enhance the social investments from year 2009 to 2012. According to a Chung-Hua Institution for Economic Research report, the future growth rate will reach 8.16% after the evaluation, Hence, the future of the industries seems to be quite bright. Currently, the government plans to put money into six newly industries through the existing ways for investment. For instance, firstly, in accordance with the "Act For The Development Of Biotech And New Pharmaceuticals Industry" article 5 provision 1 ",for the purpose of promoting the Biotech and New Pharmaceuticals Industry, a Biotech and New Pharmaceuticals Company may, for a period of five years from the time it is subject to corporate income tax, enjoy a reduction in its corporate income tax payable for up to thirty-five percent (35%) of the total funds invested in research and development ("R&D") and personnel training each year; provided, however, that if the R&D expenditure of a particular year exceeds the average R&D expenditure of the previous two years or if the personnel training expenditure of a particular year exceeds the average personnel training expenditure of the previous two years, fifty percent (50%) of the amount in excess of the average may be used to credit against the amount of corporate income tax payable. Secondly, according to same act of the article 6 provision 1 ", in order to encourage the establishment or expansion of Bio tech and New Pharmaceuticals Companies, a profit-seeking enterprise that (i) subscribes for the stock issued by a Biotech and New Pharmaceuticals Company at the time of the latter's establishment or subsequent expansion; and (ii) has been a registered shareholder of the Biotech and New Pharmaceuticals Company for a period of three (3) years or more, may, for a period of five years from the time it is subject to corporate income tax, enjoy a reduction in its corporate income tax payable for up to twenty percent (20%) of the total amount of price paid for the subscription of shares in such Biotech and New Pharmaceuticals Company; provided that such Biotech and New Pharmaceuticals Company has not applied for exemption from corporate income tax or shareholders investment credit based on the subscription price under other applicable laws and regulations. Thirdly, to promote the entire biotechnological industry development, the government has drafted the "Biotechnology Takeoff Package" for subsidizing the startup´s social investment companies which can satisfy the conditions to invest in "Drug discovery", "Medical Device" or other related biotech industries up to 5 billion with the capital invest in domestic industry over 50%, , with operating experience of multinational biotech investment companies with capital over 150 million in related industrial fields, and with the working experiences of doctor accumulated up to 60 years. Additionally, the refined agriculture industry field has not only discovered the gene selected products, but also combined the tourism with farming business for new business model creation. According to the "Guidelines for Preferential Loans for the Upgrading of Tourism Enterprises" point 4 provision 1, the expenditure for spending on machine, instruments, land or repairing can be granted a preferential loan in accordance with the rule of point 6, and government will provide a subsidy of interest for loaning Tourism Enterprises with timely payments. At last, Council for Economic Planning and Development also points out because most of technology industry has been impacted seriously by fluctuation of international prosperity due to conducting the export trade oriented strategy. Furthermore, the aspects of our export trade of technology industry have been impacted by the U.S. financial crisis and the economic decay in EU and US; and the industrial development seems to face the problem caused by over centralization in Taiwan. Hence, the current framework of domestic industry should be rearranged and to make it better by promoting the developmental project of six newly industries. Taiwan Government Had Modifies Rules to Accelerate NDA Process and Facilitate Development of Clinical Studies in Taiwan In July 2007, the "Biotech and New Pharmaceutical Development Act" modified many regulations related to pharmaceutical administration, taxes, and professionals in Taiwan. In addition, in order to facilitate the development of the biotechnology and pharmaceutical industries, the government has attempted to create a friendly environment for research and development by setting up appropriate regulations and application systems. These measures show that the Taiwanese government is keenly aware that these industries have huge potential value. To operate in coordination with the above Act and to better deal with the increasing productivity of pharmaceutical R&D programs in Taiwan, the Executive Yuan simplified the New Drug Application (NDA) process to facilitate the submission that required Certificate of Pharmaceutical Product (CPP) for drugs with new ingredients. The current NDA process requires sponsors to submit documentation as specified by one of the following four options: (1) three CPPs from three of "ten medically-advanced countries," including Germany, the U.S., England, France, Japan, Switzerland, Canada, Australia, Belgium, and Sweden; (2) one CPP from the U.S., Japan, Canada, Australia, or England and one CPP from Germany, France, Switzerland, Sweden, or Belgium; (3) a Free Sale Certificate (FSC) from one of ten medically-advanced countries where the pharmaceuticals are originally produced and one CPP from one of the other nine countries; or (4) a CPP from the European Medicines Agency. Thus, the current NDA process requires sponsors to spend inordinate amounts of time and incur significant costs to acquire two or three FSCs or CPPs from ten medically-advanced countries in order to submit an NDA in Taiwan. According to the new rules, sponsors will not have to submit above CPPs if (1) Phase I clinical studies have been conducted in Taiwan, and Phase III Pivotal Trial clinical studies have been simultaneously conducted both in Taiwan and in another country or (2) Phase II and Phase III Pivotal Trial clinical studies have been simultaneously conducted both in Taiwan and in another country. Besides, the required minimum numbers of patients were evaluated during each above phase. Therefore, sponsors who conduct clinical studies in Taiwan and in another country simultaneously could reduce their costs and shorten the NDA process in Taiwan. The new rules aim to encourage international pharmaceutical companies to conduct clinical studies in Taiwan or to conduct such studies cooperatively with Taiwanese pharmaceutical companies. Such interactions will allow Taiwanese pharmaceutical companies to participate in development and implementation of international clinical studies in addition to benefiting from the shortened NDA process. Therefore, the R&D abilities and the internationalization of the Taiwanese pharmaceutical industry will be improved.

Shifting AI Governance in East Asia: AI Legislative Progress in Japan, South Korea and Taiwan

Shifting AI Governance in East Asia: AI Legislative Progress in Japan, South Korea and Taiwan 2025/09/09 Keywords: artificial intelligence, artificial intelligence regulation I.Introduction The landscape of AI governance in East Asia is changing, with two new AI laws enacted and one on the way. In South Korea, an act titled “the Basic Act on the Development of Artificial Intelligence and the Establishment of Foundation for Trustworthiness“ (“인공지능 발전과 신뢰 기반 조성 등에 관한 기본법”, henceforth referred to as “South Korea’s AI Act” or “SKAIA”)[1]was approved on December 26[2], 2024 and promulgated on January 21, 2025. The AI Basic Act is designed to establish a national AI governance framework and systematically foster the AI industry while preventing potential AI risks.[3]A few months later, Japan’s first law regulating AI was passed by the National Diet on May 28, 2025. The new law is titled "the Act on Promotion of Research and Development, and Utilization of AI-related Technology" (“人工知能関連技術の研究開発及び活用の推進に関する法律”, henceforth referred to as "Japan's AI Act" or "JAIA")[4], which reflects the strong will of the government to catch up in the global AI race.[5] Elsewhere in the region, Taiwan’s Executive Yuan finally passed its draft AI Basic Act (“人工智慧基本法草案”) on August 28[6] [7], which must now be submitted to the Legislative Yuan for deliberation. The government hopes the new law will lay the foundation for establishing Taiwan as an AI island and a key driving force in global AI development.[8] This article will give a quick overview of the key features of the three new AI regulations to illustrate the new landscape these countries are shaping in AI governance. II.Key features of Japan’s AI Act (JAIA) 1.Purpose and principles of JAIA Given Japan's lagging AI development and rising public concerns, JAIA reflects the government's worry about falling behind global peers in AI investment and adoption.[9] It is believed that new laws are needed in addition to existing laws and regulations to promote innovation and address risks.[10] Hence JAIA aims to advance the R&D and application of AI through the formulation of basic principles and plans, and the establishment of an "AI Strategic Headquarters".[11] JAIA establishes basic principles for the promotion of the R&D and application of AI-related technologies[12], including enhancing industry R&D capabilities and competitiveness, systematically promoting AI collaboration from research to application with transparency, and enabling Japan to shape global norms through international cooperation.[13] 2.Industry Development and Promotion JAIA requires the government to develop a National AI Basic Plan, in accordance with the basic principles, to promote the R&D and application of AI. The AI Basic Plan should set out fundamental policy guidelines and measures to comprehensively and systemically advance the R&D and application of AI-related technologies, along with other necessary provisions.[14] JAIA also specifies basic measures to be included in the plan, which cover issues of promotion of R&D, expansion and sharing of facilities and data, human resources and education, international engagement in AI norm setting, and domestic guidelines making. In addition, the government should monitor AI technology trends and analyze cases of rights violations from improper AI use to develop countermeasures and provide guidance accordingly.[15] 3.Governance JAIA stipulates that an AI Strategy Headquarters should be established under the Cabinet, composed of all cabinet members and headed by the Prime Minister.[16] The AI Strategic Headquarters is tasked with comprehensively and systematically advancing AI-related technology R&D and application policies, including the formulation, promotion, and implementation of AI Basic Plans and other related initiatives.[17] The Act also empowers the AI Strategy Headquarters to invite stakeholders to provide information, opinions or explanations, and other necessary assistance.[18] 4.Risk managements and rights protection JAIA does not impose direct compliance obligations, but AI companies and research institutions are required to cooperate with government investigations and follow government guidance in cases involving violations of human rights and interests.[19] 5.Implementation of JAIA and Follow-up Work JAIA came into force in May 2025. The Japanese government is required to develop guidelines that align with international standards and launch the Strategic Headquarters for the preparation and implementation of the National AI Basic Plan. III.Key features of the South Korea’s AI Act (SKAIA) 1.Purpose and principles of SKAIA SKAIA is designed to establish a foundation for AI development and trustworthiness, increasing citizens’ rights and interests protection, quality of life, and the country’s competitiveness.[20] It focuses on advancing national AI collaboration to foster a flourishing AI sector and developing legal frameworks to mitigate risks.[21] Accordingly, the Act establishes basic AI development principles: prioritizing safety and reliability to improve quality of life, and ensuring those affected by AI output receive clear, meaningful explanations within reasonable parameters.[22] 2.Industry development and promotion Supporting AI technology and industry development is a key feature of SKAIA. It establishes comprehensive measures covering technology development, industry revitalization, SME support, industrial foundations, talent cultivation, regulatory adaptation, and international cooperation.[23] 3.Governance SKAIA also strengthens the institutional framework for AI governance. The Ministry of Science and ICT (henceforth referred to as “MSIT”) is mandated to execute an AI Master Plan every three years and empowered to investigate violations, require corrective action, and impose fines on non-compliant entities.[24] The National AI Committee is authorized to review and decide on the AI Master Plan and AI-related matters, making it the highest decision-making body for South Korea's AI policies. It is composed of the heads of central administrative agencies and civilian AI experts appointed by the president.[25] SKAIA also establishes the AI Policy Center to support MSIT on AI policy formulation, and the AI Safety Institute for AI safety matters.[26] 4.Risk management and rights protection SKAIA imposes specific obligations on operators of high-impact AI and generative AI systems. All operators must ensure system transparency and safety, while high-impact AI operators face additional responsibilities including conducting fundamental rights impact assessments.[27] High-impact AI systems are defined as AI systems that have a significant impact on or may pose a risk to human life, safety, and fundamental rights and are mainly utilized in critical infrastructure sectors and human rights-sensitive areas, or other areas specified by presidential decree.[28] The procedure for determining whether an AI system qualifies as high-impact AI will be established through subordinate legislation.[29] 5.Implementation of SKAIA and Follow-up Work SKAIA will come into effect on January 1, 2026 and the formulation of subordinate statutes that detail enforcement mechanisms and guidelines should be expedited. However, domestic critics argue that corporate obligation provisions may hinder AI development and advocate for postponing their implementation.[30] Actually, an amendment to the Act was proposed in April 2025, seeking such a postponement along with a three-year grace period.[31] IV. Key features of Taiwan’s draft AI Basic Act 1.Purpose and Principles of the draft AI Basic Act[32] Taiwan adopts a relatively conservative approach to AI policy and measures to boost industrial development have long occupied the agenda of AI governance. Given that AI is a crucial technology for national development, the draft AI Basic Act (henceforth referred to as "the draft Act") seeks to ensure that AI technology develops vigorously in a human-centered approach, encourage innovation while considering human rights, and safeguard Taiwan’s national sovereignty and cultural values.[33] Hence, the draft Act establishes seven guiding principles in line with international norms, which are sustainability, human autonomy, privacy protection and data governance, security, transparency and explainability, fairness and accountability.[34] 2.Industry Development and Promotion It is the government’s responsibility to promote the R&D and application of AI and construct the infrastructure needed.[35] In order to facilitate AI innovations, competent authorities may provide a controlled environment for testing and validating AI innovation products and services before they are released to the market or put into use.[36] Considering the wide scope of AI application and development, the government is encouraged to collaborate with the private sector, including through public-private partnerships, and should promote international cooperation on AI matters.[37] The government should also continue to comprehensively promote AI education at all levels to enhance the public's AI literacy.[38] Data is crucial for AI development, so the draft Act mandates the government to establish mechanisms to enhance data availability, and measures to facilitate AI outputs that maintain the country's multicultural values, and protect intellectual property rights.[39] 3.Risk Management and Rights Protection (1) Risk Management The draft Act includes several provisions addressing AI risks. The government should take steps to prevent AI from being used for illegal purposes. For example, Ministry of Digital Affairs (MODA) and other relevant agencies may provide or recommend tools or methods for AI evaluation and verification to avoid misuse of AI.[40] Secondly, MODA is mandated to foster an AI risk classification framework, based on which sectoral competent authorities should establish risk-based tiered management standards.[41] Thirdly, the government may, through binding regulations or non-binding administrative guidance, promote safety standards, verification, transparent and explainable traceability, or accountability mechanisms to enhance the trustworthiness of AI development and application.[42] Lastly, the government should clarify the ownership and conditions of liability for high-risk AI applications and establish relevant mechanisms for relief, compensation or insurance to protect affected parties.[43] However, AI application responsibility norms would not apply to pre-release activities in order to support technological innovation.[44] [45] (2) Rights Protection The draft Act concerns not only the privacy rights of individuals but also labor rights. The government should ensure the protection of personal data used throughout the AI lifecycle on the one hand[46] , and also protect workers' rights and provide necessary assistance to help them adapt to technological changes, especially those who have lost their jobs due to AI use.[47] 4.Governance and Implementation Despite the heated debate regarding the designation of a dedicated AI regulatory authority in the country, the Executive Yuan decided against establishing such an authority, given AI's cross-ministerial nature. Relevant competent authorities will be responsible for formulating implementing regulations and guidelines and the Executive Yuan will continue to guide relevant agencies and departments at all levels through the existing Digital Legal Coordination Meeting to facilitate the development of AI.[48] V.Analysis and conclusion Japan, South Korea and Taiwan all seek to maintain the countries' momentum in promoting AI development through AI legislation. The three parties all emphasize trustworthy AI, though they actually place greater emphasis on AI development. They share considerable common ground in the policies to foster AI industry development, such as promoting AI R&D and application and supporting infrastructure-building, and diverge in their approaches to addressing potential AI-related risks and governance structure. Japan adopts a ‘light touch’ regulatory approach to AI regulation, maintaining coherent policy coordination that responds to domestic imperatives and global trends without imposing regulatory burdens on industries.[49] The country favors a soft approach with governmental guidance. In contrast, South Korea incorporates regulatory provisions specifically targeting high-impact AI systems in its AI Basic Act, seeking to balance between enhancing national competitiveness through AI and mitigating potential risks stemming from AI misuse, though this approach actually faces some domestic opposition currently. Taiwan adopts an approach similar to Japan's. The draft AI Basic Act avoids imposing regulatory obligations, and the government will prioritize AI verification and evaluation mechanisms to ensure trustworthy AI development. Regarding governance approaches, both Japan and South Korea seek to strengthen governmental AI governance functions through legislation, with Japan establishing an AI Strategic Headquarters and South Korea creating an AI Committee, both operating under their respective Cabinets. In contrast, Taiwan's draft AI Basic Act does not address governance structural matters. Given the profound societal transformations that AI technology may bring, all three East Asian countries recognize the importance of sustained AI advancement while acknowledging the critical need to ensure AI safety and trustworthiness to protect human rights. In an era of intense global AI competition, it seems to be the best policy for governments to carefully design AI policies that strike a balance between fostering innovation and safeguarding human rights. This cautious approach is essential as significant challenges remain and AI risks demand comprehensive solutions. Reference: [1] 인공지능 발전과 신뢰 기반 조성 등에 관한 기본법（법률 제20676호, 2025. 1. 21, 제정），법제처 국가법령정보센터，https://www.law.go.kr/%EB%B2%95%EB%A0%B9/%EC%9D%B8%EA%B3%B5%EC%A7%80%EB%8A%A5%20%EB%B0% 9C%EC%A0%84%EA%B3%BC%20%EC%8B%A0%EB%A2%B0%20%EA%B8%B0%EB%B0%98%20%EC%A1%B0%EC% 84%B1%20%EB%93%B1%EC%97%90%20%EA%B4%80%ED%95%9C%20%EA%B8%B0%EB%B3%B8%EB%B2%95/(206 76,20250121) （最後瀏覽日：2025/09/11）。 [2] A New Chapter in the Age of AI: Basic Act on AI Passed at the National Assembly‘s Plenary Session, Ministry of Science and ICT, https://www.msit.go.kr/eng/bbs/view.do?sCode=eng&mId=4&mPid=2&pageIndex=&bbsSeqNo=42&nttSeqNo=1071&searchOpt=ALL&searchTxt= (last visited Sept. 11, 2025). [3] A New Chapter in the Age of AI: Basic Act on AI Passed at the National Assembly‘s Plenary Session, Ministry of Science and ICT, https://www.msit.go.kr/eng/bbs/view.do?sCode=eng&mId=4&mPid=2&pageIndex=&bbsSeqNo=42&nttSeqNo=1071&searchOpt=ALL&searchTxt= (last visited Sept. 11, 2025). [4] 人工知能関連技術の研究開発及び活用の推進に関する法律（令和7年法律第53号），e-Gov法令検索，https://laws.e-gov.go.jp/law/507AC0000000053（最後瀏覽日：2025/09/11）。 [5] CABINET OFFICE, GOVERNMENT OF JAPAN, Outline of the Act on Promotion of Research and Development, and Utilization of AI-related Technology (AI Act), https://www8.cao.go.jp/cstp/ai/ai_hou_gaiyou_en.pdf (last visited Sept. 11, 2025). [6] 〈政院通過「人工智慧基本法」草案 建構AI發展與應用良善環境 打造臺灣成為AI人工智慧島〉，行政院，https://www.ey.gov.tw/Page/9277F759E41CCD91/5d673d1e-f418-47dc-ab35-a06600f77f07（最後瀏覽日：2025/09/09）。 [7] There are other AI bills brought up by legislators in the Legislative Yuan. The purpose of this article is to analyze the AI governance priorities of the governments of Japan, South Korea, and Taiwan; therefore, other AI bills proposed by legislators are not included in the discussion. [8] 蘇文彬，〈行政院通過AI基本法草案，將不設立AI專責機關〉，iThome，2025/08/28，https://www.ithome.com.tw/news/170874 (最後瀏覽日：2025/09/09)。 [9] Japan’s AI Bill Advances Toward Enactment, Connect on Tech (May 27, 2025), https://connectontech.bakermckenzie.com/japans-ai-bill-advances-toward-enactment/ (last visited Sept. 9, 2025). [10] 松尾剛行，〈【2025年施行】AI新法とは？AIの研究開発・利活用を推進する法律を分かりやすく解説！〉，Keiyaku-Watch，https://keiyaku-watch.jp/media/hourei/2025-ai-law/（最後瀏覽日：2025/09/11）。 [11] 人工知能関連技術の研究開発及び活用の推進に関する法律（令和7年法律第53号）第1条。 [12] 人工知能関連技術の研究開発及び活用の推進に関する法律（令和7年法律第53号）第3条。 [13] Japan Enacts AI Promotion Act: Overview and Implications for Businesses, Zelo Law Square (May, 2025), https://zelojapan.com/en/lawsquare/56899 (last visited Sept. 9, 2025). [14] 人工知能関連技術の研究開発及び活用の推進に関する法律（令和7年法律第53号）第18条。 [15] 人工知能関連技術の研究開発及び活用の推進に関する法律（令和7年法律第53号）第11-17条。 [16] 人工知能関連技術の研究開発及び活用の推進に関する法律（令和7年法律第53号）第19、21-24条。 [17] 人工知能関連技術の研究開発及び活用の推進に関する法律（令和7年法律第53号）第20条。 [18] 人工知能関連技術の研究開発及び活用の推進に関する法律（令和7年法律第53号）第25条。 [19] 人工知能関連技術の研究開発及び活用の推進に関する法律（令和7年法律第53号）第16条。 [20] 인공지능 발전과 신뢰 기반 조성 등에 관한 기본법，제1조。 [21] The Korean AI Basic Act: Asia’s First Comprehensive Framework on AI, Lexology (Mar. 17, 2025), https://www.lexology.com/library/detail.aspx?g=f91ff0fb-94ed-4aa9-b667-65d6206a7227 (last visited Sept. 9, 2025). [22] 인공지능 발전과 신뢰 기반 조성 등에 관한 기본법，제3조。 [23] 인공지능 발전과 신뢰 기반 조성 등에 관한 기본법，제13-26조。 [24] 인공지능 발전과 신뢰 기반 조성 등에 관한 기본법，제40조。 [25] 인공지능 발전과 신뢰 기반 조성 등에 관한 기본법，제7조。 [26] 인공지능 발전과 신뢰 기반 조성 등에 관한 기본법，제6-12조。 [27] 인공지능 발전과 신뢰 기반 조성 등에 관한 기본법，제31-32조。 [28] 인공지능 발전과 신뢰 기반 조성 등에 관한 기본법，제4조。 [29] 인공지능 발전과 신뢰 기반 조성 등에 관한 기본법，제33조。 [30] Seungmin (Helen) Lee, South Korea’s Evolving AI Regulations, Stimson (June 12, 2025), https://www.stimson.org/2025/south-koreas-evolving-ai-regulations/ (last visited Sept. 9, 2025). [31] 〈인공지능 발전과 신뢰 기반 조성 등에 관한 기본법 일부개정법률안〉，대한민국국회，https://likms.assembly.go.kr/bill/bi/billDetailPage.do?billId=PRC_N2M5K0S3R2R0Q1O3X5X1W1U1T7P3Q6&currMenuNo=2600044（最後瀏覽日：2025/09/09）。 [32] 〈政院通過「人工智慧基本法」草案 建構AI發展與應用良善環境 打造臺灣成為AI人工智慧島〉，行政院，https://www.ey.gov.tw/Page/9277F759E41CCD91/5d673d1e-f418-47dc-ab35-a06600f77f07（最後瀏覽日：2025/09/09）。 [33] 人工智慧基本法草案第1條。 [34] 人工智慧基本法草案第3條。 [35] 人工智慧基本法草案第4條。 [36] 人工智慧基本法草案第5條。 [37] 人工智慧基本法草案第6條。 [38] 人工智慧基本法草案第7條。 [39] 人工智慧基本法草案第14條。 [40] 人工智慧基本法草案第8條。 [41] 人工智慧基本法草案第9條。 [42] 人工智慧基本法草案第10條。 [43] 人工智慧基本法草案第11條。 [44] 人工智慧基本法草案第11條。 [45] See also: Taiwan Rolls Out Draft Artificial Intelligence Law, OCACNEWS, July 18, 2024, https://ocacnews.net/article/374412 (last visited Sept. 3, 2025). [46] 人工智慧基本法草案第14條。 [47] 人工智慧基本法草案第12條。 [48] 蘇文彬，〈行政院通過AI基本法草案，將不設立AI專責機關〉，iThome，2025/08/28，https://www.ithome.com.tw/news/170874 (最後瀏覽日：2025/09/09)。 [49] Sun Ryung Park, Less Regulation, More Innovation in Japan’s AI Governance, East Asia Forum (May 21, 2025), https://eastasiaforum.org/2025/05/21/less-regulation-more-innovation-in-japans-ai-governance/ (last visited July 4, 2025).

Executive Yuan roll-out The Policy of “The Free Economic Pilot Zones”

Executive Yuan roll-out The Policy of “The Free Economic Pilot Zones”1.Executive Yuan approved a Bill titled “The Free Economic Pilot Zones Special Act”The “Free Economic Demonstration Zones” (hereinafter as FEDZs) is a critical part to improve the liberalization and internationalization of the economy of Republic of China (R.O.C). By deregulation, FEDZs was conceived as trial zones. Once the results of the program were promising, it would be expanded to the entire country. In order to engage in the regional economic and trade integration, the Executive Yuan approved a Bill titled “The Free Economic Pilot Zones Special Act” (hereinafter as Bill) on April 26th, 2013.On Mar 6th, 2014, the Joint Economic, Internal Administration , and Finance Committee of the Legislation Yuan (the Congress) discussed the Bill for reports and questions. By the end of the March, 2014, the Congress will hold five public hearings. Not until the discussion of the Bill item by item and the passage in the Congress, the second stage of the FEDZ program would not be initiated. There are five main points, including the treatments on foreigners and people from mainland China, tax incentives for Taiwanese businessman, foreign professionals and foreign companies, regulations on untaxed goods and labor, regulations on industrial development, such as the agriculture and the medical, and certain new items on education and professional services.For the reason that the government considered the need of human resources to sustain the operation of the industries, the Executive Yuan is trying to promote innovative education in FEPZs. Since the education requirements for both of public and private universities are unified in local, colleges and universities were restrained and missed some great opportunities to discover their own niches in education. Hence, innovative education in FEPZs is trying to help higher education system to introduce foreign education resources and foresight concepts, and to attract more international students. The innovative educational projects within FEPZs will also facilitate the cooperations among domestic and foreign universities, and set up experimental branch campuses, colleges, degree programs or professional courses. Besides, the financial service sector is also included. Since FEDZs is an important pusher for R.O.C to move forward in regional economic integration, accordingly, the most significant liberate item for the financial industry in the FEPZs is to allow offshore banking units and offshore security units to provide financial products and service (e.g. OSU and OBU). Meanwhile, the financial industry is predicted to receive an NTD$140 billion or more in revenues over the next five year.In summary, FEPZs is regarded as a engine propelling liberalization and internationalization. To gain the international competitiveness, the government will continue to promote policies and measures. By establishing the free economic demonstration zone, it is expected to create innovative effects into the education system and to create more job opportunities.2.Legislation Yuan has reviewd “The Free Ecomonic Pilot Zones Special Act”The Republic of China (R.O.C) have been carried out “free economic” recent years, by promoting “Free Economic Pilot Zone” (hereinafter as FEPZs) to encourage every industrial and foreign investment. Besides, FEPZs will not only keep talents and technologies in R.O.C but also liberalize and internationalize our economic.The Executive Yuan had approved a Bill titled “The Free Economic Pilot Zones Special Act” (hereinafter as the Bill) on Dec. 26th, 2013. At the end of May, the Joint Economic, Internal Administration, and Finance Committee of the Legislation Yuan (the Congress) have taken five public hearings for the Bill, and amended the Bill according to the advices proposed by specialists. Not until the deliberation of the Bill item by item and its passage in the Congress, the second stage of the FEDZ program would not be initiated. There are five main points, including the treatments on foreigners, tax incentives for R.O.C businessman, foreign professionals and foreign companies, regulations on untaxed goods and labor, regulations on industrial development, such as the agriculture and the medical service, and certain new items on education and professional services.The government considers that there have to be enough human resource to sustain the opened industries, so Executive Yuan is trying to promote innovative education in FEPZs. The core concept of FEPZs is foresight, liberalization and internationalization, the premier said, and the higher education systems belong to high-end service and have much more marketability and variability compared to other education systems. Through innovative and efficient way to manage the school could let University being much more liberalized. Furthermore, the higher education systems in R.O.C. have to connect with international education to avoid being marginalized. Our first stage of education innovation will promote to set up “degree programs” and “professional courses”. The first phase for the Ministry of Education is going to found “degree programs” or “professional courses” through collaboration way. The Ministry of Education will also draw up related regulations or guidance on standards for school cooperation, co-regulation, setup conditions, supervision, enrolling new student, and recruiting staff.? Once the Bills pass, The Ministry of Education plans to establish “branch school” and “independence campus” helping R.O.C. higher education goes internationalized.On the other hand, Our medical service also has strong international competitiveness. R.O.C is engage in developing international medical and health industry. The premier said, the Ministry of Health and Welfare have proposed some measures, such as limitation to the number of medical centre, medical personnel working hours, and NHI is not allow to use in the zones.The premier added, on the extemporaneous sittings, “The Free Economic Pilot Zones Special Act” will be the priority bills and be deliberated in the end of June By establishing the free economic demonstration zone, it is expected to propel R.O.C take part in Trans-Pacific Partnership (TPP) and the Regional Comprehensive Economic Partnership (RCEP).3.Executive Yuan’s rapid roll-out of “The Free Economic Pilot Zones”, and has published a report concerning the legal and economic implications of its the BillThe “Free Economic Pilot Zones” (hereinafter as FEPZs) plays a pivotal role in promoting market liberalization, especially at an international level. Premier of the Executive Yuan, Mr. Jiang Yi-Hua has stated that the “market economy” and “innovation economy” allows for tremendous economic prosperity to be embraced by the Republic of China (hereinafter as R.O.C). The seizing of such opportunity has been the goal of government efforts, which can be attested by the recent proposal of the “The Free Economic Pilot Zones Special Act” (hereinafter as the Bill), currently undergoing review and consultation proceedings. The Premier further stressed that the national economy should not be left excluded from international commerce, on the other hand, it is imperative that closer economic bonds with other nations are forged, therefore allowing itself open up to wider scope of opportunities for growth. The key in rendering this possible is through the enactment of laws. At a time, when Trans-Pacific nations, including the United States of America, Japan and countries from Southeast Asia, are working towards regional economic cooperation, if R.O.C. is to be left out, it is feared that its position in the global market would further be marginalized.The core innovative strengths of the FEPZs include “Smart Logistics”, “International healthcare services”, “Value added agriculture”, “Financial Services”, “Education Innovation”, all of which are implemented by employing R.O.C.’s finest workforce, knowledge, information and communications technology (ICT), geographical position and cross-strait relationship advantages, leading way for an advantageous basis for pioneering economic development. The first stage of development will be based on 6 locations proximal to the sea (including Keelung Port, Taipei Port, Kaohsiung Port, Suao Harbor, Anping Port, Taichung Port) and Taoyuan Aerotropolis and Pingtung Agricultural Biotech Park. The second stage of development would only commence after the Bill have been approved by the legislative Yuan, which would attract much capital investment, hence boosting high employment rates. Presently, besides the aforementioned regions opened up for the FEPZs, other cities and industrial sites (including those from offshore islands), are striving to gain membership of the FEPZs, or applying for empirical research of the FEPZs.The Executive Yuan has published a report concerning the legal and economic implications of its the Bill on May 2014. The report largely consists of assessments made by varying governing bodies, such as Ministry of Home Affairs, Financial Supervisory Commission etc., on the implications of the draft concerning real estate, employment, fiscal income, logistics, conditions for medical care, agriculture, higher education, social environment and social wealth redistribution etc.Furthermore, international attention has been closely centered on the progress of FEPZs. During the “The third review of the trade policies and practices of Chinese Taipei” after R.O.C accession to the World Trade Organization (WTO) held on the 17th of September 2014 in Geneva, each member state has demonstrated expectations arising out of the direction and planning undertaken for the FEPZs. National economic and international commercial reforms are under way and have seen much progress in further promoting the overall strength of the economic system, in an effort to respond to the rapid global political and economic developments, for example, through the signing of Economic Cooperation Framework Agreement (ECFA), and the implementation of FEPZs policies. In the future, it will be expected that R.O.C. will strive for a more integral international commercial system, allowing much capital investment inflows as well as the cultivating of high-caliber human resources.To promote more liberal and internationalized development of Taiwan economy, government of Republic of China (R.O.C) approved the “Free Economic Pilot Zone (FEPZ) Plan,” which the Bill is currently censored in Legislation Yuan and the measures would be implemented in two phases. The first phase of FEPZs would be initiated within six free trade ports, Taoyuan airport free trade zone, and Pingtung Agricultural Biotechnology Park; other industries that match up with the idea of liberalization, internationalization and foresight can all be incorporated into FEPZ through continuing examination under Execution Yuan. After this special legislation is passed, the set-ups of demonstration zones can be applied by authorities either of central or of local government and the related promotion works of the second phase will be unfolded immediately.Heading to the target of becoming Kin-Xiao (Kinmen and Xiaomen) Free Trade Zone, Kinmen government planned to apply to be one of the FEPZs and thus cooperated with Taiwan Institute of Economic Research (TIER) on December 11, for a commissioned research (which was later released on the conference of accelerating Kin-Xia FTZ on December 19) on evaluating if Kinmen is qualified for an application of FEPZs. Kinmen’s critical location and the featured industries have composed a perfect environment complying with the ideas such as value-added agriculture, international healthcare and innovative education for FEPZ. For instance, the white liquor industry in Kinmen represents the international management and promotion of agricultural products, and is the best example for value-added agriculture. “Long-term Healthcare Village in Kinmen,” which is currently developing in Kinmen, would also be a drive for international healthcare industry. Based on the Taiwan-featured culture, “International Education City” could be developed with a liberal and innovative atmosphere, which would attract famous schools in world to set up their branch school in Kinmen. Above all, Kinmen County vice Mayor, Wu Yo-Chin, indicated that Kinmen would be the first choice for FEPZ and would hold the key to open a new gate for the Cross-Strait. The vice Mayor emphasized that Kinmen government has well budgeting and financial management, which needn’t the extra aids from central government, yet Kinmen was excluded in the first phase of FEPZs. Although Kinmen would apply to be a FEPZ in the second phase after the special legislation passed, Kinmen still strived for taking part in the first phase of FEPZs due to the uncertain schedule for implementation of regulations on FEPZs.National Development Council (NDC), however, gave an opinion on issue of Kinmen applying to be in the first phase of FEPZs, which declared again the original plan for the first phase only included six free trade ports, Taoyuan airport free trade zone, and Pingtung Agricultural Biotechnology Park. NDC also suggested Kinmen could still follow after the first phase and apply to be a FEPZ in the second phase.
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