China bolsters integrity of clinical trials

China has recently released a new edition of the Good Clinical Practice for Drugs — a guideline designed to ensure the ethical and scientific conduct of clinical studies, aiming to strengthen the nation's research ecosystem and support innovation in biotechnology.

The document, jointly issued by the National Medical Products Administration and three other government departments last week, is an update of the version that has been in effect since 2020. The new version is set to take effect on Sept 1.

According to the administration, key highlights of the guideline include the addition of provisions on data governance, as well as an emphasis on compliance with ethical principles, scientific rules, and relevant laws and regulations when applying new technologies and methods.

The guideline states that data governance should run throughout the entire clinical trial process, ensuring accurate reporting, validation, and interpretation of trial-related information.

Researchers are also required to establish procedures to guarantee the reliability, traceability, and security of electronic data, and to prevent data loss or tampering.

The guideline explicitly identifies the principal investigator as the responsible person at the site level and names the sponsor as the ultimate accountable party for all trial-related activities.

Sponsors are also required to consider the protection of participants' rights and safety as of fundamental importance when carrying out trials.

To further enhance the protection of participants, the guideline calls for strengthened ethics review and informed consent processes, particularly for trials involving special populations and issues such as serious and persistent noncompliance.

The guideline also specifies key review content and methods for ethics committees, as well as critical quality management factors.

According to the administration, the revision comes as the number of clinical trials for innovative drugs in China rises rapidly, and the fast-growing global biopharmaceutical industry demands higher clinical trial standards.

Official data shows that this year, China has approved 10 innovative drugs as of March, including eight domestic products. In 2025, the nation granted market approval to a total of 76 innovative drugs, marking a historic high.

Meanwhile, more than 2,500 clinical trials for innovative drugs were carried out in China last year, accounting for 48 percent of the global total.

Cui Hao, deputy director of the Center for Food and Drug Inspection under the administration, said the new guideline has clarified the responsibilities of principal investigators and other participants, and introduced more detailed rules on whole-process quality management, with a focus on identifying potential risks and addressing them in advance.

He added that the guideline also encourages and supports the application of artificial intelligence and other smart and novel technologies.

It also stresses that the protection of trial participants and data reliability represent the bottom line and red line, while specific operations, such as team organization and resource allocation, can be arranged flexibly, he added.

(China Daily)