To analyze the key changes in the 2026 edition of the good clinical practice (GCP) and to explore specific implementation measures.

By interpreting the revised provisions of the new GCP edition and comparing them with the 2020 edition, together with reference to ICH E6 (R3), this study examines the implementation measures necessitated by these key changes.

The provisions regarding the management of trial protocols, investigator’s brochures, and essential documents, as well as most terminology, have been removed; implementation now follows ICH E6 (R3) guidelines, while retaining fundamental requirements and China-specific regulations. The General Provisions incorporate the three core principles of the ICH E6(R3), clarify the ultimate responsibilities of the principal investigator and the sponsor, introduce a separate chapter on data governance, and streamline the safety reporting process.

To implement the new version of GCP and to promote the development of clinical drug trials in China, sponsors should align with international standards to strengthen their sense of responsibility and implement quality management and data governance; principal investigators and clinical trial institutions should enhance their awareness of ultimate responsibility and clarify the boundaries of authorization; and service providers should perform their duties in compliance with contractual obligations.