BEIJING — China is tightening standards governing drug clinical trials as regulators seek to strengthen participant protection, data governance and research quality while supporting the rapid expansion of the country’s biotechnology sector.
The National Medical Products Administration (NMPA), together with the National Health Commission, National Administration of Traditional Chinese Medicine and National Disease Control and Prevention Administration, has issued a revised Good Clinical Practice guideline for drugs that will take effect on Sept. 1, replacing the 2020 version.
The revised rules place greater emphasis on ethical principles, scientific standards, compliance with laws and regulations and the use of new technologies and methods in clinical research, according to the NMPA. They also introduce provisions on data governance and clarify that principal investigators bear responsibility at the clinical trial site level.
The changes come as China expands its role in global drug development. The NMPA said the number of innovative drug trials in China has been rising rapidly and that the growth of the global biopharmaceutical industry requires higher standards for clinical research.
At the same time, China has been pursuing faster regulatory pathways for selected innovative drugs. In September 2025, the NMPA established a 30-working-day review and approval route for eligible innovative drug applications, alongside the existing 60-day implicit approval mechanism. The expedited route covers certain Class I innovative drugs, including products for pediatric and rare diseases and some globally synchronized development programmes.
The NMPA said the faster pathway does not reduce its safety requirements. Applicants using it must assess the compliance and capabilities of trial institutions and investigators, conduct risk assessment and management, and commit to starting the trial within 12 weeks of approval.
Under the revised clinical-trial framework, ethics committees are expected to strengthen review and risk assessment throughout the research process, while investigators and sponsors have greater responsibilities for managing risks and protecting participants.
The NMPA has said the accelerated approval system is intended to improve the quality and efficiency of clinical development while maintaining international technical standards. China is a standing member of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use and says its clinical-trial standards are aligned with ICH requirements.
The revised Good Clinical Practice rules are scheduled to come into force on Sept. 1, marking the next formal stage of China's effort to strengthen oversight of an expanding clinical research sector while continuing to accelerate development of innovative medicines.
