Executive Yuan Yuan Promoted “Productivity 4.0” to Boost Global Competitiveness
Executive Yuan Yuan Promoted “Productivity 4.0” to Boost Global Competitiveness
1.Executive Yuan held the “Productivity 4.0: Strategy Review Board Meeting” to boost industrial transformation
The Executive Yuan held the “Productivity 4.0: Strategy Review Board Meeting” on June 4-5th , 2015. The GDP per capita of manufacturing and service industries, including machinery, metal processing, transportation vehicles, 3C, food, textile, logistics, health care, and agriculture, are expected to be over 10 million NT dollars by 2024.
This meeting focuses on three topics: Productivity 4.0 industry and technology development strategy, advanced development strategy on advanced manufacturing and innovation application, and strategy on engineering smart tech talents cultivation and Industry-academic Cooperation. The three main themes to be used to put the advanced manufacturing into force are smart automation and robots, sensing and control technologies from Internet of Things (IoT), and technologies used in analyzing the big data. As a result, the digitalization of small- and medium-sized business and smart operation of big business are as the cornerstones to build service-oriented systems and develop advanced manufacturing in R.O.C.. Facing challenges of labor shortages and aging labor forces, the Executive Yuan is planning to implement “Productivity 4.0” to stimulate the process of industry transformation of value-added innovation and provide new products and services in global market.
In implementing the above-mentioned policy goals, the Executive Yuan is planning three directions to be followed. First, global competitiveness is depended upon key technologies. As OEMs, manufacturing industry in R.O.C. is unable to provide products of self-owned brand and is vulnerable while facing challenges from other transnational companies. Second, the Premier, Dr. Mao Chi-kuo, made reference of the bicycle industry’s successful development model as an example for the Productivity 4.0 “A-Team” model. Through combining technologies and organizations, the aim is to build competitive supply chains across all the small- and medium-sized business. Finally, the new skills training and the cultivation of talents are more urgent than ever before. While technical and vocational schools, universities and postgraduate studies are needed to be equipped with sufficient fundamental knowledge, those already in the job market have to learn the skills and knowledge necessary for industrial transformation so that they could contribute their capabilities and wisdom for Ourfuture.
2.Executive Yuan Approved “Productivity 4.0 Initiative” to Promote Industry Innovation and Transformation
The Executive Yuan has approved the Productivity 4.0 Initiative on September 17, 2015. Before its approval, the Office of Science and Technology (OST) gave a presentation on the Draft of the Productivity 4.0 Initiative on July 23, 2015 detailing the underlying motives behind the program. Confronted with the challenges our traditional industries and OEMs meet, including labor shortages (the national laboring population ranging from age 15 to 65 has seen a substantial decrease of 0.18 to 0.2 million annually) and a aging labor force, the the Productivity 4.0 Initiative sets the directions for industrial development tackling these issues through six main strategies: enhancing and fine-tuning flagship industries’ smart-supply-chain ecosystems, encouraging the establishing of startups, localizing production and services, securing autonomy in key technologies, cultivating practical and technical talents and injection of industrial policy tools.
After hearing the presentation on the Initiative, the Premier, Mao Chi-kuo, made reference to the core ideas of the Productivity 4.0 Initiative in his concluding remarks. “The core concept of the Productivity 4.0 Initiative is to propel R.O.C. to a pivotal position in the global manufacturing supply chain by capitalizing on the nation’s core strength in industrial technology, while fostering an outstanding work environment stimulating synergy between employees and automotive systems in order to cope with R.O.C.’s imminent labor shortage,” Mao said
Also focusing on the Productivity 4.0 Initiative, the Premier gave a keynote speech titled ‘Views on the current economic and social issues’ at the Third Wednesday Club. He takes the view that the GDP downslide is of a structural nature and the government is going to guide the economy towards an upward path by assisting industries to innovate and transform. In an effort to remove the three major obstacles to innovation and entrepreneurship— discouraging laws and regulations, difficulty in raising capital and gathering financing as well as lack of international partnerships, the government has been diligently promoting the Third Party Payment Act as well as setting-up R.O.C. Rapid Innovation Prototyping League for Enterprises.
Among these measures, Industry 4.0 has been at the core of the Initiative, in which cyber-physical production system (CPS) would be introduced by integrating Cloud-computing and Internet of Things technology to spur industrial transformations, specifically industrial manufacturing, added-value services and agricultural production. The Productivity 4.0 Initiative is an imperative measure in dealing with R.O.C.’s imminent issues of labor shortage, and the aging society, its promising effects are waiting to unfold.
3.Executive Yuan’s Further Addendum to “Productivity 4.0 Plan”: Attainment of Core Technologies and the Cultivation of Domestic Technical Talents
In an continual effort to put in place the most integrated infrastructural setting for the flourishing of its “Productivity 4.0 Plan”, Executive Yuan Premier Mao Chi-Kuo announced on the 22nd October that the overhaul infrastructural set-up will be focused on the development of core technologies and the cultivation of skilled technical labor. To this end, the Executive Yuan is gathering participation and resources from the Ministry of Economic Affairs (hereafter MOEA), Ministry of Education, Ministry of Science and Technology, Ministry of Labor, the Council of Agriculture, among other governmental bodies, collecting experiences and knowledge from academia and researchers, in order to improve the development of pivotal technologies, the training of skilled technical labor and consequently to improve and reform the present education system so as to meet the aforementioned goals.
Premier Mao Chi-Kuo pointed out that Productivity 4.0 is a production concept in which the industry is evolved from mere automation- to intelligent-based manufacturing, shifting towards a “small-volume, large-variety” production paradigm, closing the gaps between production and consumption sides through direct communication, hence allowing industry to push itself further on changing its old efficiency-based production model to an innovation-driven one.
Apart from the Research and Development efforts geared towards key technologies, Premier Mao stressed that the people element, involved in this transformative process, is what dictates Productivity 4.0 Plan’s success. The cross-over or multi-disciplinary capability of the labor force is especially significant. In order to bring up the necessary work force needed for Productivity 4.0, besides raising support for the needed Research and Development, an extensive effort should be placed in reforming and upgrading the current educational system, as well as the technical labor and internal corporate educational structure. Moreover, an efficient platform should be implemented so that opinions and experiences could be pooled out, thus fostering closer ties between industry, academia and research.
The MOEA stated that the fundamental premise behind the Productivity 4.0 strategy is that by way of systematic, brand-orientated formation of technical support groups, constituted by members of industry, academia and research, will we able to develop key sensor, internet and core technologies for our manufacturing, business and agriculture sector. It is estimated that by the end of year 2016, the Executive Yuan will have completed 6 major Productivity 4.0 production lines; supported the development of technical personnel in smart manufacturing, smart business and smart agriculture, amounting to 2,500 persons; established 4 inter-university, inter-disciplinary strategic partnerships in order to prepare much needed labor force for the realization of the Productivity 4.0 Plan. It is estimated that by the year 2020, industry has already developed the key technologies through the Productivity 4.0 platform, aiding to decrease by 50% the time currently needed to for Research and Development, increasing the technological sovereignty by 50% and accrue production efficiency by 15% and above. Furthermore, through the educational reforms, the nation will be able to lay solid foundations for its future labor talents, as well as connecting them to the world at large, effectively making them fit to face the global markets and to upgrade their production model.
After the European Union's Artificial Intelligence Law, the draft of AI Basic Law is announced in Taiwan. 2024/09/19 Countries around the world are currently seeking to establish AI governance principles. The U.S. currently has only AI executive orders and state bills, and the European Union (EU) first AI law came into effect in August 2024. Taiwan has announced a draft of AI Basic Law for public comments on July 15, 2024, which, if passed by the Legislative Yuan, will become the world's second special legislation on AI. Taiwan's Coming AI Basic Law - Legislative Development and Progress With the successful conclusion of the 2024 Paris Olympics, AI technology has demonstrated its potential on the global stage, bringing new experiences to the public in varied areas, such as sport competition analysis, athlete training, and referee assisting, and showing that AI has also crossed over into the sports industry, in addition to its known applications in areas such as healthcare, finance, transportation, arts and culture fields. As AI will be apply in various industries, it may also bring new risks or impacts to individuals or society. Countries are seeking to establish guidelines and principles for AI governance. The EU’s Artificial Intelligence Act, which was announced to take effect in August 2024. Even in the AI pioneer, the U.S., there are currently only U.S. President’s AI Executive Orders and bills introduced by Congress or state governments. When Taiwan President Lai announced the promotion of the Island of Artificial Intelligence, Taiwan also had a draft of the AI Basic Law announced for public comments by the National Science and Technology Council (NSTC) on July 15, 2024, proposing the principles of basic values for the development of AI in Taiwan. What is the Basic Law in Taiwan? There are 11 basic laws/acts in Taiwan, including the Fundamental Science and Technology Act, and the Ocean Basic Act, etc. A basic law/act is a legislative model of principle, progress, or guideline for a specific important matter. The AI Basic Law serves as a declaration of policy integration, reveals the government's goals and principles, and regulates the executive branch without directly regulating the people, or deriving the rights for substantive claims. Why Taiwan need a Basic Law on Artificial Intelligence? AI is evolving rapidly, and its applications are spreading to a wider range of areas. If all sectors and administrations have different values, there will be no way for a country to develop AI. NSTC has announced a total of 18 articles in the draft, in Article 3 first set out 7 common principles, such as human autonomy, from the AI research and development to the final market application must comply with the basic values; and in the following provisions of Article 4 to declare that the government's 4 major promotional focuses. The most important provision is found in Article 17, which requires that government ministries should review and adjust the functions, businesses and regulations under their scope in accordance with the Basic Law, so as to enable the executive branch to accelerate its response to the changes brought about by AI, and to share a common set of values: the promotion of innovation while taking human rights into consideration. 7 basic principles The draft AI Basic Law in the announcement contains the following 7 basic principles: 1. Sustainable development and well-being: Social equity and environmental sustainability should be taken into account. Appropriate education and training should be provided to minimize the possible digital gap, so that people can adapt to the changes brought about by AI. 2. Human autonomy: It shall support human autonomy, respect for fundamental human rights and cultural values such as the right to personal integrity, and allow for human oversight, thereby implementing a human-based approach that upholds the rule of law and democratic values. 3. Privacy Protection and Data Governance: The privacy of personal data should be properly protected to avoid the risk of data leakage, and the principle of data minimization should be adopted; at the same time, the opening and reuse of non-sensitive data should be promoted. 4. Security and safety: In the process of AI research and development and application, security measures should be established to prevent security threats and attacks and to ensure the robustness and safety of the system. 5. Transparency and explainability: The output of AI should be appropriately disclosed or labeled to facilitate the assessment of possible risks and the understanding of the impact on related rights and interests, thereby enhancing the trustworthiness of AI. 6. Fairness and non-discrimination: In the process of AI research and development and application, the risks of bias and discrimination in algorithms should be avoided as much as possible, and should not lead to discriminatory results for specific groups. 7. Accountability: Ensure the assumption of corresponding responsibilities, including internal governance responsibilities and external social responsibilities. 4 key areas of promotion 1. Innovative Collaboration and Talent Cultivation: Ensuring the resources and talent needed for AI. 2. Risk management and application responsibility: Risks must be identified and managed before AI systems can be safely applied. 3. Protection of rights and access to data: People's basic rights, such as privacy, cannot be compromised. 4. Regulatory Adaptation and Business Review: Policies and regulations must be agile to keep pace with AI development. The AI Basic Law is paving the way for Taiwan's future opportunities and challenges. AI development requires sufficient resources, data and a friendly environment; to ensure the safe application of AI, it is necessary to first identify and plan for different possible risks, and the draft AI Basic Law has initially drawn a blueprint for the above innovative development and safe application. In the future, various government ministries will need to work together to keep up with the wave of AI innovation in terms of business and legal regulations for multiple fields and industries. It is believed that Taiwan can leverage the advantages in the semiconductor industry and talent resources to gain a favorable global strategic position for the development of AI, as well as to help achieve the goal of "AI for good" to enhance the well-being of Taiwan people through a sound legal environment.
Shifting AI Governance in East Asia: AI Legislative Progress in Japan, South Korea and TaiwanShifting 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).
Analyzing the Framwork of the Regulation「Act For The Development of Biotech And New Pharmaceuticals Industry」in TaiwanTaiwan Government passed The「Act for the Development of Biotech and New Pharmaceuticals Industry」for supporting the biopharmaceutical industry. The purpose of the Act is solely for biopharmaceutical industry, and building the leading economic force in Taiwan. To fulfill this goal, the Act has enacted regulations concerning funding, taxation and recruitment especially for the biopharmaceutical industry. The Act has been seen as the recent important law in the arena of upgrading industry regulation on the island. It is also a rare case where single legislation took place for particular industry. After the Act came into force, the government has promulgated further regulations to supplement the Act, including Guidance for MOEA-Approved Biotech and New Pharmaceuticals Company Issuing Stock Certificate, Deductions on Investments in R&D and Personnel Training of Biotech and New Pharmaceuticals Company, Guidance for Deduction Applicable to Shareholders of Profit-Seeking Enterprises -Biotech and New Pharmaceuticals Company etc. The following discussions are going to introduce the Act along with related incentive measures from an integrated standpoint. 1 、 Scope of Application According to Article 3 of the Act, 「Biotech and New Pharmaceuticals Industry」 refers to the industry that deals in New Rugs and High-risk Medical devices used by human beings, animals, and plants; 「Biotech and New Pharmaceuticals Company」 refers to a company in the Biotech and New Pharmaceuticals Industry that is organized and incorporated in accordance with the Company Act and engages in the research, development, and manufacture of new drugs and high-risk medical devices. Thus, the Act applies to company that conducts research and manufacture product in new drug or high-risk medical devices for human and animal use. Furthermore, to become a Biotech and New Pharmaceuticals Company stipulated in the Act, the Company must receive letter of approval to establish as a Biotech and New Pharmaceuticals Company valid for five years. Consequently, company must submit application to the authority for approval by meeting the following requirements: (1) Companies that conduct any R&D activities or clinical trials must receive permission, product registration, or proof of manufacture for such activities from a competent authority. However, for those conducted these activities outside the country will not apply. (2) When applied for funding for the previous year or in the same year, the expense on R&D in the previous year exceeds 5% of the total net revenue within the same year; or the expenses exceeds 10% of the total capital of the company. (3) Hired at least five R&D personnel majored in biotechnology. For New Drug and High-Risk Medical Device are confined in specific areas. New Drug provided in the Act refers to a drug that has a new ingredient, a new therapeutic effect or a new administration method as verified by the central competent authorities. And High-Risk Medical Device refers to a type of Class III medical devices implanted into human bodies as verified by the central competent authorities. Therefore, generic drug, raw materials, unimplanted medical device, and medical device are not qualified as type III, are all not within the scope of the Act and are not the subject matter the Act intends to reward. 2 、 Tax Benefits Article 5, 6 and 7 provided in the Act has followed the footsteps of Article 6 and 8 stipulated of the Statute, amending the rules tailored to the biopharmaceutical industry, and provided tax benefits to various entities as 「Biotech and New Pharmaceuticals Company」, 「Investors of Biotech and New Pharmaceuticals Industry」, 「Professionals and Technology Investors」. (1) Biotech and New Pharmaceuticals Company In an effort to advance the biopharmaceutical industry, alleviate financial burden of the companies and strengthen their R&D capacity. The Act has provided favorable incentive measures in the sector of R&D and personnel training. According to Article 5: 「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 profit-seeking enterprise income tax payable, enjoy a reduction in its corporate income tax payable, for up to 35% of the total funds invested in research and development (R&D) and personnel training each year.」 Consequently, company could benefit through tax deduction and relieve from the stress of business operation. Moreover, in supporting Biotech and New Pharmaceutical Company to proceed in R&D and personnel training activities, the Act has set out rewards for those participate in ongoing R&D and training activities. As Article 5 provided 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 pervious two years, 50% of the exceed amount in excess of the average may be used to credit against the amount of profit-seeking enterprise income tax payable. 「However, the total amount of investment credited against by the payable corporate income tax in each year shall not exceed 50% of the amount of profit-seeking enterprise income tax payable by a Biotech and New Pharmaceuticals Company in a year, yet this restriction shall not apply to the amount to be offset in the last year of the aforementioned five-year period. Lastly, Article 5 of the Act shall not apply to Biotech and New Pharmaceutical Company that set up headquarters or branches outside of Taiwan. Therefore, to be qualified for tax deduction on R&D and personnel training, the headquarters or branches of the company must be located in Taiwan. (2) Investors of Biotech and New Pharmaceuticals Company To raise funding, expand business development, and attract investor continuing making investments, Article 6 of the Act has stated that 「In order to encourage the establishment or expansion of Biotech and New Pharmaceuticals Companies, a profit-seeking enterprise that subscribes for the stock issued by a Biotech and New Pharmaceuticals Company at the time of the latter's establishment or subsequent expansion; and has been a registered shareholder of the Biotech and New Pharmaceuticals Company for a period of 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 profit-seeking enterprise income tax payable for up to 20% of the total amount of the price paid for the subscription of shares in such Biotech and New Pharmaceuticals Company.」 Yet 「If the afore-mentioned profit-seeking enterprise is a venture capital company (「VC」), such VC corporate shareholders may, for a period of five years from the fourth anniversary year of the date on which the VC becomes a registered shareholder of the subject Biotech and New Pharmaceuticals Company, enjoy a reduction in their profit-seeking enterprise income tax payable based on the total deductible amount enjoyed by the VC under Paragraph 1 hereof and the shareholders' respective shareholdings in the VC.」 The government enacted this regulation to encourage corporations and VC to invest in biotech and new pharmaceutical company, and thus provide corporate shareholders with 20% of profit-seeking enterprise income tax payable deduction, and provide VC corporate shareholders tax deduction that proportion to its shareholdings in the VC. (3) Top Executives and Technology Investors Top Executives refer to those with biotechnology background, and has experience in serving as officer of chief executive (CEO) or manager; Technology Investors refer to those acquire shares through exchange of technology. As biopharmaceutical industry possesses a unique business model that demands intensive technology, whether top executives and technology investors are willing to participate in a high risk business and satisfy the needs of industry becomes a critical issue. Consequently, Article 7 of the Act stated that 「In order to encourage top executives and technology investors to participate in the operation of Biotech and New Pharmaceuticals Companies and R&D activities, and to share their achievements, new shares issued by a Biotech and New Pharmaceuticals Company to top executives and technology investors (in return of their knowledge and technology) shall be excluded from the amount of their consolidated income or corporate income of the then current year for taxation purposes; provided, however, that if the title to the aforesaid shares is transferred with or without consideration, or distributed as estate, the total purchase price or the market value of the shares at the time of transfer as a gift or distribution as estate shall be deemed income generated in that tax year and such income less the acquisition cost shall be reported in the relevant income tax return.」 Additionally, 「For the title transfer of shares under the preceding paragraph, the Biotech and New Pharmaceuticals Company concerned shall file a report with the local tax authorities within thirty 30 days from the following day of the title transfer.」 Purpose of this regulation is to attract top executives and technology personnel for the company in long-term through defer taxation. Moreover, the Biotech and New Pharmaceutical Company usually caught in a prolong period of losses, and has trouble financing through issuing new shares, as stipulated par value of each share cannot be less than NTD $10.Thus, in order to offer top executive and technology investors incentives and benefits under such circumstances, Article 8 has further provided that」Biotech and New Pharmaceutical Companies may issue subscription warrants to its top executives and technology investors, provided that the proposal for the issuance of the aforesaid subscription warrants shall pass resolution adopted by a majority votes of directors attended by at least two-thirds (2/3) of all the directors of the company; and be approved by the competent authorities. Holders of the subscription warrants may subscribe a specific number of shares at the stipulated price. The amount of stipulated price shall not be subject to the minimum requirement, i.e. par value of the shares, as prescribed under Article 140 of the Company Act. Subscription of the shares by exercising the subscription warrant shall be subject to income tax in accordance with Article 7 hereof. if a Biotech and New Pharmaceutical Company issue new shares pursuant to Article 7 hereof, Article 267 of the Company Act shall not apply. The top executives and technology investors shall not transfer the subscription warrant acquired to pursuant to this Article.」 These three types of tax benefits are detailed incentive measures tailor to the biopharmaceutical industry. However, what is noteworthy is the start date of the benefits provided in the Act. Different from the Statue, the Act allows company to enjoy these benefits when it begins to generate profits, while the Statute provides company tax benefits once the authority approved its application in the current year. Thus, Biotech and New Pharmaceuticals Company enjoys tax benefits as the company starts to make profit. Such approach reflects the actual business operation of the industry, and resolves the issue of tax benefits provided in the Statue is inapplicable to the biopharmaceutical industry. 3 、 Technical Assistance and Capital Investment Due to the R&D capacity and research personnel largely remains in the academic circle, in order to encourage these researchers to convert R&D efforts into commercial practice, the government intends to enhance the collaboration among industrial players, public institutions, and the research and academic sectors, to bolster the development of Biotech and New Pharmaceuticals Company. However, Article 13 of Civil Servants Service Act prohibits officials from engaging in business operation, the Act lifts the restriction on civil servants. According to Article 10 of the Act provided that」For a newly established Biotech and New Pharmaceuticals Company, if the person providing a major technology is a research member of the government research organization, such person may, with the consent of the government research organization, acquired 10% or more of the shares in the Biotech and New Pharmaceuticals Company at the time of its establishment, and act as founder, director, or technical adviser thereof. In such case, Article 13 of the Civil Servants Service Act shall not apply. And the research organization and research member referred to thereof shall be defined and identified by the Executive Yuan, in consultation with the Examination Yuan.」 This regulation was enacted because of the Civil Servants Services Act provided that public officials are not allowed to be corporate shareholders. However, under certain regulations, civil servants are allowed to be corporate shareholders in the sector of agriculture, mining, transportation or publication, as value of the shares cannot exceed 10% of the total value of the company, and the civil servant does not served in the institution. In Taiwan, official and unofficial research institution encompasses most of the biotechnology R&D capacity and research personnel. If a researcher is working for a government research institution, he would be qualified as a public servant and shall be governed by the Civil Servants Service Act. As a result of such restriction, the Act has lifted the restriction and encouraged these researchers to infuse new technologies into the industry. At last, for advancing the development of the industry, Article 11 also provided that 」R&D personnel of the academic and research sectors may, subject to the consent of their employers, served as advisors or consultants for a Biotech and New Pharmaceuticals Company.」 4 、 Other Regulations For introducing and transferring advanced technology in support of the biopharmaceutical industry, Article 9 stated that 「Organization formed with government funds to provide technical assistance shall provide appropriate technical assistance as may be necessary.」 Besides technical assistance, government streamlines the review process taken by various regulatory authorities, in order to achieve an improved product launch process result in faster time-to-market and time-to profit. As Article 12 provided that 「the review and approval of field test, clinical trials, product registration, and others, the central competent authorities shall establish an open and transparent procedure that unifies the review system.」
Taiwan Planed Major Promoting Program for Biotechnology and Pharmaceutical IndustryTaiwan 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.
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