Revised Clinical Trials Rules for Drugs to Take Effect in July 2020

In order to deepen the reform of the system of evaluation, review and approval of drugs, promote studies on good clinical practice (GCP) on drugs and improve the quality of drugs, the National Medical Products Administration joined hands with the National Health Commission in revising the Good Clinical Practice on Drugs, which will take effect on 1 July 2020 to regulate the clinical trials of drugs for registration purposes. The new rule sets forth the standard for the entire process of a clinical trial for drug from design, conduct and performance to monitoring, auditing, recording, analysis and reporting.   

The GCP makes it clear that the Ethics Committee must examine whether any of the participating patients join a clinical trial under coercion, enticement and other improper influence. It must also ensure that the informed consent form and other written documents supplied to the patients contain information on reimbursements, including how they are processed and the amount involved.

Source: National Medical Products Administration