Regulation of Decentralized Clinical Trial Models in China

1. Introduction

Decentralized Clinical Trials (DCTs) are clinical studies in which certain trial activities, such as patient recruitment, informed consent, medical consultations, delivery of investigational products, and collection of clinical data, take place outside traditional hospital or research-centre settings. These activities may occur at participants’ homes, local healthcare facilities, or through digital platforms and telemedicine.

In China, decentralized clinical trials are governed by a combination of pharmaceutical legislation, clinical-trial regulations, Good Clinical Practice (GCP) requirements, personal information protection laws, and rules governing medical institutions and online healthcare. China does not have a single comprehensive statute exclusively regulating every aspect of DCTs. Instead, the legality of a decentralized model depends on whether its individual activities comply with the applicable regulatory framework.

The principal objective is to facilitate clinical research and digital healthcare while protecting participants’ safety, ensuring the reliability of clinical data, and preserving regulatory oversight.

2. Principal Legal and Regulatory Framework

A. Drug Administration Law of the People's Republic of China

The Drug Administration Law, revised in 2019, establishes the fundamental legal framework for pharmaceutical research, clinical trials, drug registration, and regulatory supervision. The National Medical Products Administration (NMPA) is the principal authority responsible for regulating drugs and their clinical development.

For decentralized trials, its significance lies in the requirement that clinical research be conducted under appropriate authorization, quality-control procedures, and participant-protection standards. Conducting trial activities remotely does not exempt a sponsor from the applicable clinical-trial requirements.

Where a decentralized model involves investigational drugs being shipped directly to participants, the sponsor must ensure appropriate storage, transportation, dispensing, accountability, and traceability. Remote distribution cannot be used to circumvent applicable pharmaceutical controls.

B. Good Clinical Practice (GCP)

China's revised Good Clinical Practice for Drug Trials, issued by the NMPA and the National Health Commission (NHC) in 2020 and effective from 1 July 2020, provides the central operational framework for drug clinical trials.

Its requirements are particularly relevant to DCTs in the following areas:

Sponsor responsibility: The sponsor retains responsibility for trial quality, participant protection, monitoring, and reliable data, even when activities are delegated to third-party service providers.

Investigator responsibility: The investigator must ensure appropriate medical supervision, evaluate adverse events, and maintain oversight of trial-related activities.

Informed consent: Participants must receive understandable information about trial procedures, foreseeable risks, alternatives, and their rights.

Data integrity: Electronic records must be reliable, traceable, appropriately protected, and capable of verification.

Safety reporting: Adverse events and serious adverse events must be documented, evaluated, and reported according to the applicable requirements.

Accordingly, telemedicine, electronic diaries, wearable devices, and remote monitoring may support trial conduct, but they cannot eliminate the responsibilities imposed on sponsors, investigators, and research institutions.

C. Good Clinical Practice for Drug Clinical Trials No. 50 of 2026

An important recent development is the revised Chinese GCP, issued in 2026 and effective from 1 September 2026, replacing the 2020 version. It incorporates principles from ICH E6(R3), including a more risk-proportionate approach to clinical-trial quality management. This is particularly relevant to decentralized models because sponsors must assess risks associated with remote procedures, technology, service providers, and data collection.

ClinRegs

D. Technical Guideline for Decentralized Clinical Trials in Rare Disease Drug Development (2024)

China made a significant policy advance by issuing the Technical Guideline for Applying Decentralized Clinical Trials in Rare Disease Drug Development in May 2024. The guideline took effect upon publication.

It recognizes that rare-disease patients may face mobility limitations, geographic barriers, and difficulties repeatedly attending specialist hospitals. It therefore addresses fully remote and hybrid trial models and the use of digital health technologies.

Its main regulatory implications include:

Selecting decentralized procedures according to the characteristics of the disease and investigational drug.

Evaluating whether remote assessments can produce scientifically reliable evidence.

Ensuring that digital devices and platforms are appropriate for the intended clinical purpose.

Protecting informed consent, privacy, and participant safety throughout the trial.

Maintaining appropriate medical supervision and contingency arrangements.

The guideline is specifically directed at rare-disease drug development and should not be mistaken for a universal authorization for every type of decentralized clinical trial.

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3. Approval and Ethics Review

China's Drug Registration Provisions require drug clinical trials to be conducted through qualified, registered clinical-trial institutions and to undergo ethics review. The protocol must receive the required regulatory authorization and ethics approval before the trial proceeds.

A decentralized model must therefore distinguish between the institution responsible for the trial and the locations or service providers used to perform individual activities. Conducting visits at a participant's home does not automatically transform that home into an authorized clinical-trial institution.

Sponsors should document which activities occur remotely, which require qualified medical personnel, and which must take place at an appropriately equipped institution. Material changes to the protocol, consent arrangements, or safety-monitoring procedures must be assessed for the necessary ethics review and regulatory notifications or approvals.

National Medical Products Administration

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4. Data Protection and Digital Health Technologies

DCTs commonly generate sensitive information through electronic consent systems, wearable devices, video consultations, mobile applications, and remote monitoring platforms.

Three legal considerations are particularly important:

1. Personal Information Protection Law (PIPL): Health information generally qualifies as sensitive personal information. Processing must satisfy applicable necessity, purpose, security, and consent requirements. Cross-border transfers of clinical data may trigger additional regulatory obligations.

2. Data Security Law: Sponsors and service providers must assess data-security risks, control access, and implement appropriate safeguards for clinical databases and digital systems.

3. Medical-device regulation: Wearables, diagnostic devices, and software may be subject to medical-device requirements depending on their intended purpose and regulatory classification. A device's use in a trial does not remove applicable product-control obligations.

These rules mean that a sponsor should establish data-access controls, audit trails, identity verification, secure transmission, retention procedures, and documented vendor responsibilities before adopting a decentralized design.

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5. Relevant Case Law and Judicial Principles

As of October 2026, no clearly established, publicly reported Chinese court judgment specifically resolving the legality of a decentralized clinical trial model was identified in the sources reviewed. Consequently, it would be inaccurate to present ordinary medical-negligence decisions as direct DCT precedents. The following legal authorities nevertheless establish principles relevant to disputes involving decentralized research.

A. Drug Administration Law: Clinical-trial safety and consent

Articles 20–22 of the Drug Administration Law address ethics review, informed consent, and the response to safety concerns during clinical trials.

Legal significance: If a participant suffers injury following a remote consultation or home-based administration of an investigational drug, the fact that the activity occurred outside a hospital does not automatically relieve the sponsor or investigator of applicable duties. Liability would depend on the facts, the relevant obligations, causation, and the applicable legal provisions.

National Medical Products Administration

B. Drug Registration Provisions: Institutional and ethics oversight

Articles 22, 25, and 26 of the Drug Registration Provisions address qualified trial institutions, ethics review, and approved trial protocols.

Legal significance: A decentralized arrangement must remain within the applicable authorization and institutional framework. Failure to secure required ethics approval or to comply with the approved protocol may expose responsible parties to regulatory consequences, even if the digital technology itself operates correctly.

National Medical Products Administration

C. Human genetic resources and cross-border research

Where a DCT collects Chinese human genetic resources, including relevant biological samples or genetic information, the applicable human genetic resources regime must also be considered. Cross-border collaboration, access, or provision of such resources can raise additional compliance requirements.

Legal significance: Cloud-based research platforms and overseas sponsors should not assume that remote collection or electronic transmission removes the need to comply with Chinese human-genetic-resource and data-transfer rules.

These are applications of statutory and regulatory principles, rather than findings from DCT-specific court judgments.

6. Conclusion

China regulates decentralized clinical trials through a combination of drug law, GCP, ethics review, digital-data protection, medical-device regulation, and specialized guidance for rare-disease research. The 2024 rare-disease DCT guideline and the revised 2026 GCP are particularly significant developments.

The central legal principle is that decentralization changes where trial activities occur, but does not eliminate the sponsor's, investigator's, or institution's regulatory responsibilities. Compliance therefore requires an appropriate trial design, valid informed consent, qualified medical oversight, reliable digital records, adequate safety monitoring, and effective protection of participant information.