At the 2026 Bio Taiwan Committee (BTC) meeting held on August 24, Liu Lee-Cheng (劉理成), President of the Taiwan Bio Industry Organization, addressed the session on “Driving the Implementation of Cross-Sector Applications.” He noted that although the government has established clear policy directions in areas such as the Healthy Taiwan initiative, drug supply resilience, domestically produced biosimilars, orphan drugs, and innovative medicines, the industry continues to face challenges involving health data, cross-sector integration, regulatory expertise, clinical trials, National Health Insurance (NHI) market access, and supply resilience.

Liu called for the establishment of an independent third-party health data platform and a data sandbox, as well as the standardization of health data through FHIR APIs. He also recommended developing comprehensive rules for AI training, data de-identification, and data exchange to facilitate the commercialization of Taiwan’s medical data and expand its international applications.

Regarding cross-sector integration, Liu proposed leveraging Taiwan’s established strengths in the chemical, textile, machinery, electronics, and automation industries to build an industrial ecosystem encompassing biotechnology, advanced manufacturing, and supply-chain resilience.

On the regulatory front, Liu recommended strengthening the international alignment of the Center for Drug Evaluation (CDE), enhancing the recruitment and development of experienced regulatory reviewers, and harmonizing the criteria used by the Taiwan Food and Drug Administration (TFDA) and the National Health Insurance Administration (NHIA) to define and evaluate new drugs.

For new drug development, he advocated establishing a national one-stop organization responsible for clinical trial strategy and implementation, together with a translational fund, to accelerate the commercialization of R&D outcomes.

Regarding NHI market access, Liu proposed parallel reviews by the TFDA and NHIA to shorten the time between regulatory approval and inclusion in the NHI reimbursement system. He also called for the establishment of a more reasonable drug-pricing mechanism.

To strengthen pharmaceutical supply resilience, Liu recommended creating an inter-ministerial coordination mechanism and a dedicated fund to promote the contract manufacturing and domestic production of critical medicines. He further proposed developing regional supply-chain partnerships with Japan, Australia, Singapore, and other countries to reduce the risks associated with dependence on a single source of supply.

【2026-08-24/Giobal Bio&Investment】