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 enhance the nation's research ecosystem and support innovation in biotechnology.

Jointly issued by the National Medical Products Administration and three other government departments on Monday, the guideline updates the previous version that had been in effect since 2020.

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.

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 new methods.

Furthermore, the guideline clarifies that the principal investigator is the responsible party at the trial site level, and stresses the protection of participants, rigorous review by ethics committees, and the implementation of quality management throughout the entire clinical trial process.

The guideline is set to take effect on Sept 1 of this year.