Minister without Portfolio Shih Chung Chen stated that the National Infectious Disease Biobank (NIDB) will be completed next year, enabling the systematic collection of biological specimens, provision of preservation technology services, and facilitation of preclinical animal testing. Together with the Human Biobank and the National Health Insurance Database, these three pillars will form the “three arrows” driving the progress of Taiwan’s biotechnology industry, expediting its global expansion and paving the way for another “national champion” industry.

Chen noted that the government’s Healthy Taiwan Vision reflects its strong confidence in the future of the biotechnology sector. He emphasized that Taiwan must vigorously promote this development, as the country already excels in medical sciences and is further supported by its powerful AI and semiconductor industries. Under the National Hope Project, biotechnology and medical innovation are key focuses. In terms of regulation, the six subsidiary acts under the Regenerative Medicine Act are nearing completion, while the human biobank system continues to mature. With the government taking the lead, Chen expressed optimism for the industry’s long-term prospects.

He added that the Ministry of Health and Welfare (MOHW) will continue to enhance review efficiency and strengthen alignment with international standards. The upcoming completion of the NIDB will allow Taiwan to systematically collect and store specimens, offer technical preservation services, and conduct animal testing—working in synergy with the Human Biobank and National Health Insurance Database to accelerate biotech advancement, global positioning, and industrial growth.

Director-General Chih-Kang Chiang of the Taiwan Food and Drug Administration (TFDA) delivered a keynote speech titled “New Trends in Biomedical Product Development and Regulation under the Healthy Taiwan Vision.” He said that from the perspective of a regulatory authority, TFDA will ensure the safety, efficacy, and quality consistency of medical and pharmaceutical products while also facilitating industrial growth through special project guidance and diversified certification mechanisms, helping to advance Taiwan’s biomedical products into the international market.

Chiang highlighted that one of the major goals of the Healthy Taiwan for All 4.0 initiative is to enable “Taiwan’s biotech industry to contribute to the world.” To achieve this, the government has been actively promoting the integration of smart healthcare and wellness, introducing regulatory frameworks such as the Regenerative Medicine Act, the Regenerative Medicinal Products Act, the National Health Insurance Data Management Act, and the Human Biobank Management Act, providing robust legal support for biotech and healthcare innovation.

He also shared the latest developments from TFDA, including smart drug lifecycle management, project-based consultation services, regulations for regenerative medicinal product manufacturing and aseptic management, accelerated medical device certification for international market entry, optimization of medical device review and guidance mechanisms, promotion of smart medical device transformation and international alignment, multi-certification mechanisms for laboratory-developed tests (LDTs), and enhanced international engagement and regulatory harmonization.

Dr. Chien-Chuan Wang, Vice President of the Chung-Hua Institution for Economic Research, discussed Taiwan’s economic and trade opportunities and challenges amid fluctuating tariffs and exchange rates. He described the U.S. President Donald Trump’s tariff policy as “more volatile than the economy itself,” characterizing Trump’s political style as “one-man rule, Gemini temperament, and a trio of advisers.” Wang noted that Trump’s so-called “reciprocal tariffs” are a bargaining tool aimed at reducing U.S. debt and forcing concessions from trading partners. Thus, when engaging with Trump’s administration, nations must rely on leverage, not democratic ideals.

Wang further predicted that Taiwan is entering its third wave of investment expansion—following the first wave of industrial migration to China in the 1990s and the second wave of New Southbound investments in 2018. He suggested that if Taiwan can transfer complete industrial chains—such as semiconductors, pharmaceuticals, and food production—to the U.S., effectively creating an “extended science park” there, it would not only secure early access to key markets but also strengthen Taiwan’s strategic role in the global technology and manufacturing network.

He concluded by emphasizing that in dealing with Trump’s “high asking, low settling” negotiation style, Taiwan must adopt a proactive strategy and secure its position in the U.S. market in advance, so as to find opportunities amid adversity in the ongoing global trade realignment.

Resource: 政委陳時中：「國家感染性疾病資源庫」明年完工 完善生技產業進步的三支箭