China NMPA Releases GCP for Drugs (2025) Draft Revision: Key Changes and 2020 GCP Comparison

On October 27, 2025, the National Medical Products Administration (NMPA) General Affairs Department issued the "Good Clinical Practice for Drugs (2025) (Revised Draft for Comments)", proposing a significant modernization of China’s clinical trial governance framework. The draft aims to strengthen trial participant protection, improve data integrity, and clarify sponsor and investigator responsibilities across a streamlined structure of six chapters covering the full trial lifecycle.

Public feedback is open until November 27, 2025. For support interpreting the draft or preparing formal comments for NMPA submission, contact Cisema.

Regulatory Background

The existing Good Clinical Practice (2020) framework provides the regulatory foundation for drug clinical trials in China. The 2025 draft revision reflects China’s ongoing shift toward internationally aligned, risk-based, quality-focused clinical trial oversight, incorporating principles from global GCP updates such as Quality by Design (QbD) principles and proportionate risk management.

The draft also incorporates the "Measures for the Administration of Drug Registration", strengthening legal consistency across China’s drug regulatory system and improving alignment with ongoing reforms.

Overview of Key Revisions in the 2025 GCP Draft

The draft consolidates eight chapters into six,introduces a new standalone “Data Governance” chapter, and redefines accountability by designating the sponsor as the ultimate responsible entity. The Principal Investigator (PI) is explicitly defined as the responsible person at the site level.

Comparison Area2020 GCP2025 Draft (for Public Comment)Regulatory BasisBased on the Drug Administration Law, Vaccine Administration Law, and Implementation Regulations of the Drug Administration Law.Adds Measures for the Administration of Drug Registration to enhance legal coherenceCore Principles“Ethical Priority,” “Scientific Basis”, “Risk–Benefit Balance,” “Conflict of Interest Avoidance”Adds principles of “Quality by Design”, “Risk Proportionate Oversight”, “Fit for Purpose Design”, and “Appropriate Use of New Technologies”Structure8 chapters, 84 articles6 chapters, 54 articles; including a new “Data Governance chapter”Responsibility DefinitionUnclear final accountabilitySponsor designated as ultimately responsible; PI defined as the site-level responsible personEthics ReviewNo mandated review interval, limited detail on vulnerable populations.Annual ethics review required; added safeguards for minors, individuals without civil capacity, and emergency research scenarios.Investigational Product ManagementNo BE sample retention requirementMandates BE sample retention at BE study sites for two years post-marketing approval; enhances vaccine oversight provisions.Data ManagementBasic data authenticity requirementsAdds system validation, metadata requirements, audit trails, and dataset confirmation procedures, and tracking of blinded/unblinded data events.Safety ReportingLimited detail on SUSAR and DSURStrenghtens SUSAR rapid reporting obligations to the CDE and requires shared DSUR reporting to investigators and ethics committees.New TechnologiesNot addressedPermits use if scientifically justified, ethicalcompliant, and aligned with regulatory standards.

2025 GCP Draft: Key Provisions Explained

The following sections outline the key provisions, highlighting how each component strengthens quality management, ethical oversight, and data reliability across the trial lifecycle.

1. Expanded Legal and Regulatory Framework

The draft expands the GCP’s formal legal basis and introduces several modernized principles, including:

Quality by Design integrated into early planning and protocol development
Risk Proportionate oversight based on trial complexity and participant risk
Fit for Purpose processes, documentation, and data requirements
Clear guidelines for the use of emerging technologies in clinical research

These principles strengthen scientific rigor while supporting flexibility and innovation, especially in decentralized trials and digital data environments.

2. Enhanced Ethics Oversight

The 2025 draft significantly strengthens the authority and responsibilities of ethics committees.

Key updates include:

Mandatory reviews at least every 12 months.
Explicit safeguards for minors, incapacitated persons, and emergency research participants.
Authority to suspend or terminate studies not meeting ethical standards.
Prohibition of any agreement terms that waive participant rights.

Together, these provisions support continuous ethical oversight, moving beyond the one-time approval model common under older frameworks.

3. Clear Investigator and Institutional Accountability

The draft clarifies expectations for clinical trial sites and investigators.

Principal Investigator (PI) defined as the site-level responsible person with required qualifications, training, and experience.
Mandatory BE sample retention at bioequivalence study site for two years following marketing approval.
Strengthened source data criteria: attributable, legible, contemporaneous, original, accurate, and complete, with version change tracking.

These updates reinforce traceability and site-level data credibility, supporting audit readiness.

4. Strengthened Sponsor Obligations

The sponsor is explicitly named as the final accountable entity for trial quality, data integrity, and risk management.

Key obligations include:

Comprehensive Blinding Management, including prevention and documentation of unblinding events.
Risk Management covering identification, evaluation, control, communication, and review of key quality factors.
Mandatory compliance with special management requirements for Vaccine studies
Expanded insurance and compensation responsibilities, including medical costs and free provision of trial drugs and tests.

These provisions ensure end-to-end quality responsibility across the sponsor’s clinical operations and outsourcing arrangements.

5. Comprehensive Data Governance Requirements

The introduction of a standalone Data Governance Chapter is one of the most significant updates.

Mandatory metadata and audit trails for all collected data.
Electronic system validation with documented access control, backup, and security measures.
Confirmation of final datasets against source data before database lock.
Documentation and traceability of blind maintenance and unblinding events.

These measure align with global expectations such as ALCOA+ and EU/ICH E6(R3) data integrity standards.

6. Updated Definitions and Supplementary Rules

The draft adds and clarifies several definitions, including “Principal Investigator (PI)”, “Potential Serious Safety Risks”, and “Quality Management System (QMS).”

These additions reduce ambiguity and support consistent interpretation across sponsors, CROs, sites, and ethics committees .

Impact on Foreign Sponsors and CROs

The draft imposes more explicit accountability and more stringent data governance standards. Key implications include:

Expanded electronic system validation and data integrity documentation requirements.
Mandatory annual ethics committee reviews that may affect approval timelines.
Broader insurance and liability obligations for trial participants.
More rigorous expectations for risk management and QbD integration into study design.

Foreign companies conducting clinical trials in China should evaluate internal SOPs, vendor oversight, and data systems to ensure readiness .

Compliance Preparation: Steps Toward GCP 2025 Readiness

To prepare for the expected adoption of the updated GCP framework, organizations should begin planning now. Recommended steps include:

Performing GCP gap assessment against 2025 draft requirements.
Updating SOPs and quality system documentation to reflect new data governance, ethics committee, and sponsor accountability requirements.
Validating electronic systems to demonstrate audit readiness, traceability, and ALCOA+ compliance.
Preparing processes for annual ethics reviews and updated safety reporting timelines.

Early preparation will reduce operational disruption once the final GCP is issued.

Final Thoughts

The Good Clinical Practice for Drugs (2025) Draft Revision represents one of the most significant updates to China’s clinical trial governance in recent years. With its stronger emphasis on data lifecycle integrity, risk-based oversight, and clarified responsibilities, the draft moves China closer to international GCP harmonization.

For sponsors and CROs navigating these evolving expectations, Cisema provides support through GCP compliance audits, risk-based process reviews, data integrity support, and regulatory consulting.

Get in touch with our experts today for more information about Cisema’s pharmaceutical services.