Guidance for Industry
In response to the needs for clinical trial design and regulatory consultation in Taiwan, as well as to enhance clinical trial capabilities, the CDE has published the “Guidance for Industry”. The CDE aims to improve the consistency, predictability, and transparency of clinical trial review and management as well as strives to align with international standards to assist domestic industries in planning clinical trial design and executing strategies, ultimately increasing the quality and effectiveness of clinical trials.
Each year, the CDE actively studies international and domestic clinical trial regulations to deeply understand their review criteria and details. To strengthen interaction with industry, the CDE analyzes international regulatory and scientific review documentation and integrates it into Guidance for Industry for domestic R&D teams to reference and follow in order to safeguard patient safety and promote industrial development.
Since 2018, the CDE has been publishing new Guidance for Industry annually, focusing on innovative breakthrough therapies, items that meet domestic public health needs, and topics required for R&D. These publications combine the professional knowledge and rich experience of senior reviewers and reference opinions from experts in industry, government, and academia. The contents of the Guidance for Industry cover various aspects, including quality, pharmacology/toxicology, pharmacokinetics/pharmacodynamics, statistics, and clinical topics. The CDE also proactively reviews previously published Guidance for Industry to determine if updates are needed. This aims to provide regulatory adjustments necessary for review and continually update regulatory science with technological progress, promoting the synchronization of domestic regulations with international standards to aid reference and application in academia and industry.