关键词: 临床试验, 药物评价, 规范, 评论

Abstract:

The 2026 version of Good Clinical Practice (GCP, hereinafter referred to as the 2026 GCP) has been officially released and is pending implementation. Fully aligned with E6(R3): Guideline for Good Clinical Practice issued by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) in January 2025, this revision structurally reconstructs the institutional framework based on the current development status and existing pain points of China’s clinical trial industry. The 2026 GCP streamlines redundant provisions from previous editions and adds an independent chapter on data governance. It establishes three core philosophies, namely “quality by design”, “proportionate risk management” and “fit-for-purpose”, and further clarifies the lifelong shared liabilities of sponsors and principal investigators. Combining the original text of the 2026 GCP, international regulatory updates and industrial statistical data, this paper systematically sorts out the policy background of this revision and provides an in-depth interpretation of all core revisions. It also analyzes the impacts of the 2026 GCP on industrial landscape, compliance systems and internationalization. Furthermore, adaptive suggestions are proposed from the perspectives of pharmaceutical enterprises, clinical trial institutions and industrial regulators, so as to provide references for domestic clinical trial stakeholders to achieve compliant transformation and advance high-quality development of the industry.

Key words: Clinical trial, Drug evaluation, Benchmarking, Comment