• Last updated：2026-01-21
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Driving "Healthy Taiwan" through Science-Based Governance
Established in 1998, the Center for Drug Evaluation (CDE) has long served as a core professional pillar of Taiwan’s public health governance system. Supporting the nation’s scientific review and evaluation of pharmaceuticals, medical devices, and health technologies, CDE helps ensure consistent standards of quality, safety, and efficacy across the healthcare system. Building on three decades of accumulated professional expertise, CDE is entering a critical phase of transformation. Aligned with the national vision of "Healthy Taiwan," CDE will continue to support its role as a patient-centered, innovation-accelerating, and highly efficient regulatory science platform. By deepening international engagement and professional trust, and by working closely with domestic and global partners, CDE aims to strengthen the sound development of health policies and enhance the resilience of Taiwan’s pharmaceutical and medical device system.

Patient-Centered Approach: Enhancing Medicines and Medical Devices Accessibility and Health Benefits
Under the framework of public health governance, access to medicines and medical devices is not only a key health policy priority but also a fundamental cornerstone of universal health and social equity. CDE places patient needs at its core, leveraging regulatory science expertise to ensure quality and safety while employing flexible and efficient evaluation models. This includes the appropriate use of real-world data (RWD) and post-marketing evidence to support the timely integration of clinically significant drugs and medical devices into the healthcare system. This approach assists the government in making decisions that reflect actual clinical needs, translating innovative achievements into tangible health benefits for the public.

Integrating Consultation and HTA: Accelerating Innovation Delivery
To accelerate the transition of innovation from R&D to clinical application, CDE will continue to strengthen early-stage regulatory consultation while deepening its integration with Health Technology Assessment (HTA). This alignment enhances the consistency and usability of clinical evidence required for healthcare decision-making, shortens the timeline from development to application, and supports subsequent reimbursement and policy evaluations—ensuring that innovative technologies become accessible treatment options for patients more quickly.

Digital and AI-Assisted Review: Building a New Generation of Scientific Oversight
In response to global trends in regulatory digitalization and the rapid growth of data, CDE is progressively implementing artificial intelligence (AI) and digital tools to support technical analysis and data synthesis. While maintaining professional judgment as the foundation of regulatory decision-making, these tools will enhance the efficiency, transparency, and predictability of regulatory reviews. Together, these efforts support CDE’s goal of developing a next-generation scientific review system that balances quality, speed, and governance credibility, ensuring the long-term stability and sustainable operation of the regulatory framework.

Strengthening Pharmaceutical and Medical Device Supply Resilience: Deepening International Responsibility and Collaboration
A stable supply of pharmaceuticals and medical devices is fundamental to national healthcare system readiness and public health security. In alignment with national policies priorities, CDE draws on international regulatory science experience to advance reliance-based cooperation models. By promoting international reciprocity, reducing redundancy, and supporting cross-regional mutual assistance mechanisms under appropriate frameworks, Taiwan is positioned to play a more responsible and trusted role within the global health product supply network, further strengthening the sustainability and resilience of pharmaceutical and medical device supply.

Anchored in International Standards: Advancing a Trusted "Taiwan Approval"
As it approaches its 30th anniversary, CDE remains committed to advancing regulatory science and technical excellence by integrating international best practices with local implementation. With WHO Listed Authority (WLA) designation serving as a key international benchmark, CDE continues to deepen global collaboration and professional mutual trust. Through these efforts, "Taiwan Approval" is evolving beyond regulatory compliance to represent internationally recognized standards of quality, safety, and scientific rigor—supporting the sustainable development of a Healthy Taiwan and strengthening Taiwan’s role and influence in global public health governance.