BEIJING — China’s National Medical Products Administration released updated guidelines for drug clinical trials that prioritize clinical value in development, speed up marketing authorizations and ban fees for trial participants. The 89-article document, spanning nine chapters, takes effect on May 15.

Officials outlined the changes in a Xinhua post late last month. They stressed a shift toward ‘clinical value-oriented’ drug development. The revisions target bottlenecks in research and registration, according to the announcement.

Sponsors now face stricter rules on selecting contract research organizations and trial sites. Article 8 requires them to pick institutions and researchers with proven capabilities. Responsibilities include protecting subjects, managing trial drugs, handling data and controlling risks.

Trial organizers and sites cannot charge subjects any fees tied to participation. The rules also demand compliance with Good Laboratory Practice for non-clinical studies and Good Clinical Practice for trials. All records and data must be true, accurate, complete and fully traceable.

Clinical trial supplies must meet Good Manufacturing Practice standards. These measures aim to build trust in trial integrity and support faster paths to market for innovative medicines.

The guidelines introduce accelerated review channels for drug marketing authorizations. Project management requirements have been refined to streamline operations. Officials said these steps will encourage biopharma developers to innovate while ensuring patient safety.

China has pushed regulatory reforms in recent years to attract global drugmakers and close the gap with Western markets. The changes come amid a surge in domestic biopharma investment. Last year, the country approved 68 novel drugs, up from 39 in 2021, according to industry trackers.

Experts see the fee ban as a direct response to past complaints about exploitative practices in some trials. Data traceability rules align with international standards, potentially easing cross-border collaborations.

The revisions build on 2019 updates to China’s drug administration law. Those eased import rules for innovative therapies. Now, the focus sharpens on execution in clinical stages.

Industry groups welcomed the news. The China Association of Pharmaceutical Commerce called the changes ‘a major step forward’ for aligning with global norms. Foreign firms like Pfizer and AstraZeneca, with growing footprints in China, stand to benefit from quicker reviews.

Challenges remain. Enforcement will test regulators’ capacity amid a boom in trial applications. Over 4,500 clinical trials ran in China last year, per official data.

The government emphasized subject protection throughout. Sponsors must report adverse events promptly and maintain open communication with regulators.

These rules position China as a more competitive hub for biopharma R&D. Developers can now pursue value-driven strategies with clearer guardrails on compliance and ethics.