06/30/2026  |  Gareth Macdonald  |  BioXconomy

https://www.bioxconomy.com/clinical-and-research/china-updates-clinical-trial-rules-on-data-ethics 

The revisions stress data transparency and participant privacy protection.

Revised Good Clinical Practice (GCP) regulations that come into force in China in September introduce new rules on data governance and emphasize the importance of compliance with international ethical principles.

China’s National Medical Products Administration published the document (Mandarin) on June 8, explaining the aim was to “optimize the quality management of drug clinical trials” and cultivate a standardized and efficient research ecosystem.

The guideline—which is the first update since 2020—consists of sections covering a range of trial-related topics, from rules for principal investigators and institutions involved in studies through to drug industry sponsors.

Clinical trial data governance is covered in a new section, which stresses that information from studies should be stored in a transparent manner. It also underlines the importance of ensuring the privacy of study participants.

“All paper and electronic materials related to clinical trials should be properly recorded, processed, and stored to ensure the reliability and traceability of the data. The privacy and personal information of trial participants should be protected, in accordance with the relevant requirements of our country's personal information protection laws.

“The systems and processes used for data collection, management, and analysis should meet the intended purposes and be commensurate with the risks to trial participants and the importance of the collected data” the NMPA writes.*

The revision also reminds trial sponsors, CROs and research sites of the need to protect study participants in line with international standards. 

“Clinical trials of drugs should comply with the principles of the Declaration of Helsinki and related ethical requirements set forth by the World Medical Association. 

“The rights and safety of trial participants are the primary considerations, taking precedence over the benefits to science and society. Ethical review and informed consent are important measures to ensure the rights and safety of trial participants.”*

Implications

The revised guidelines will impact domestic drug companies and services firms as well as international sponsors and CROs, according to Hong Kong-based consultancy Cisema, which urged the latter group to review processes to ensure they are compliant.

“Foreign companies conducting clinical trials in China should evaluate internal SOPs, vendor oversight and data systems to ensure readiness,” Cisema wrote when the draft revision was published in March, citing data, ethics and design as areas to look at.

*Automatically translated from Mandarin.