China Revises Good Clinical Practice Rules

On 1 September 2026, the revised Good Clinical Practice for Drug Trials (the “2026 GCP”) took effect, replacing the previous version issued in 2020. 

The revision follows China’s full implementation, from 31 March 2026, of the International Council for Harmonisation (“ICH”) Guideline for Good Clinical Practice E6(R3) (“ICH E6(R3)”). This marked the full implementation in China of the latest internationally harmonised GCP standard and its principles for the quality management of clinical trials.

Against this background, the 2026 GCP further aligns China’s domestic regulatory framework with ICH E6(R3). Rather than duplicating ICH E6(R3) in full, the 2026 GCP focuses on requirements that need to be established as domestic regulatory rules, while detailed operational guidance and recommended practices continue to be addressed through the implementation of ICH E6(R3).

The 2026 GCP has also been substantially streamlined, from nine chapters and 83 articles to six chapters and 54 articles, while introducing a standalone chapter on data governance and further clarifying the responsibilities of key participants in clinical trials.

1 ICH E6(R3) Principles Embedded in the 2026 GCP

The 2026 GCP incorporates the three core concepts of ICH E6(R3) – quality by design, fit for purpose and proportionality – into its general principles:

• Quality by Design. Quality considerations should be incorporated into a clinical trial from the outset, rather than relying primarily on quality control after the trial has commenced. Article 6 requires critical-to-quality factors and associated risks to be identified and proportionate risk-control measures to be implemented to protect trial participants and ensure the reliability of trial results. Sponsors are also required to incorporate quality by design into the development of clinical trial protocols.
• Fit for Purpose. Systems and processes should be appropriate for their intended purposes. Article 9, for example, requires systems and processes used for data collection, management and analysis to be fit for their intended purposes. This principle allows the nature and extent of controls to be calibrated according to the function and importance of the relevant system or process.
• Proportionality. The extent of controls should be proportionate to the relevant risks. Article 9 links controls over data systems and processes to the risks to trial participants and the importance of the relevant data. Similarly, Article 40 requires sponsor oversight measures to be fit for purpose and proportionate to the complexity and risks of the clinical trial.

2 Clearer Responsibilities

While the 2020 GCP already set out the responsibilities of sponsors, investigators and clinical trial institutions, the 2026 GCP more clearly defines ultimate accountability for the conduct of clinical trials. In particular, it expressly identifies the PI as the person ultimately responsible at the trial site and the sponsor as ultimately responsible for trial-related activities. It also makes clear that delegation or outsourcing does not relieve the relevant party of its ultimate responsibility for the delegated or outsourced activities.

The revised framework therefore draws a clearer distinction between the performance of trial activities and ultimate accountability for those activities. This is particularly relevant where sponsors and trial institutions rely on CROs, SMOs and other service providers: operational activities may be outsourced, but the regulatory responsibility of the relevant sponsor, PI or institution remains.

3 Data Governance Throughout the Data Lifecycle

One of the most significant structural changes is the introduction of a standalone Data Governance chapter. While the 2020 GCP already contained requirements on data reliability, traceability and computerised systems, the 2026 GCP establishes a more comprehensive data governance framework covering the entire clinical trial data lifecycle.

Sponsors, PIs and clinical trial institutions are expressly required to assume data governance responsibilities within their respective areas of responsibility. Data governance must extend throughout the data lifecycle to ensure that clinical trial information can be accurately reported, verified and interpreted.

The 2026 GCP places particular emphasis on metadata and audit trails. Data obtained from any source, including data captured directly in computerised systems, must be accompanied by corresponding metadata, including audit trails. Sponsors, PIs and clinical trial institutions must also establish appropriate methods for using, evaluating, accessing and managing metadata, as well as procedures for reviewing data and metadata. Data corrections must remain traceable, while electronic data transfers between computerised systems must follow validated processes designed to ensure data reliability, traceability and security.

The revised rules also set out more detailed requirements for computerised systems, including system validation, data security and backup, user and access-right management and audit trails. For companies relying on EDC, ePRO and other digital systems, the focus is therefore not only on the accuracy of the final dataset, but also on whether data integrity and the history of the data can be demonstrated throughout its lifecycle.

The 2026 GCP also strengthens requirements for maintaining blinding. The integrity of blinding must be maintained at all applicable stages of a blinded trial, with appropriate measures taken to prevent inadvertent unblinding from introducing bias. Relevant parties must identify and document in advance the roles, responsibilities and processes for accessing unblinded information. Any unblinding or inadvertent unblinding during the trial must be documented, its potential impact on the trial results assessed and appropriate measures taken.

Key Takeaway

The implementation of the 2026 GCP brings domestic requirements into closer alignment with international GCP standards and places greater emphasis on risk-based quality management, clear accountability and lifecycle data governance.

Companies involved in clinical trials in China should review their existing clinical trial governance and compliance frameworks against the revised requirements, including their internal policies and procedures, allocation of responsibilities, oversight of service providers and data management practices. In particular, sponsors should ensure that increased reliance on CROs, technology providers and other third parties is supported by appropriate contractual arrangements and effective oversight, as ultimate responsibility for trial-related activities remains with the sponsor.