China Proposes 30-Day Review Pathway for Innovative Drug Clinical Trials Nationwide
核心洞察
China's NMPA has issued a draft announcement proposing to reduce clinical trial review times from 60 to 30 business days for qualifying innovative drugs nationwide.
The accelerated pathway applies to Registration Category I innovative drugs (搜索) meeting specific criteria including nationally prioritized drugs, pediatric/rare disease (搜索) programs, or global synchronized trials.
The proposal expands beyond the previous Beijing and Shanghai pilot program to cover all innovative drugs including chemical drugs (搜索), biologics (搜索), and traditional Chinese medicines (搜索) across the country.
China's National Medical Products Administration (NMPA) has issued a draft announcement proposing to accelerate clinical trial reviews by reducing the timeline for certain innovative drugs from 60 business days to 30 business days nationwide. The Draft Announcement on Optimizing the Review and Approval of Clinical Trials for Innovative Drugs builds upon a pilot program launched in July 2024 that was initially limited to Beijing and Shanghai.
Expanded Scope and National Implementation
The proposed policy significantly broadens the application scope beyond the original pilot program. The 30-day review pathway will apply to all Registration Category I innovative drugs (搜索), encompassing chemical drugs (搜索), biologics (搜索), and traditional Chinese medicines (搜索). This represents a substantial expansion from the geographically limited pilot program to a nationwide implementation.
The draft announcement removes the prior limitation to Beijing and Shanghai, making the accelerated review process available across China for qualifying innovative drug applications.
Qualification Criteria for Expedited Review
To qualify for the 30-day review pathway, drugs must meet one of three specific conditions. First, the drug must be designated as a nationally prioritized innovative drug receiving comprehensive policy support. Second, the drug must be included in the CDE (搜索)'s pediatric-focused "Spark Program" or "Rare Disease (搜索) Care Program." The Spark Program is a pilot initiative launched by CDE in May 2025 to support anti-tumor (搜索) drug research and development for children.
Third, the drug must be a globally synchronized investigational product where the application is for a Phase I, II, or III international multi-center trial. This criterion reflects China's growing integration into global drug development networks.
Applicant Requirements and Compliance Standards
The draft announcement establishes specific requirements for applicants seeking the expedited review pathway. Applicants must submit materials demonstrating thorough review of the lead trial institution's ethics compliance and principal investigator qualifications. The materials must also demonstrate "regulatory compliance circumstances," though the draft does not provide further explanation of this requirement.
A critical requirement mandates that applicants collaborate with trial sites to synchronize project approval and ethics review prior to submitting the clinical trial application with NMPA. Additionally, applicants must possess risk assessment capabilities proportionate to the complexity of the drug's research and development program.
Applicants are required to commit to initiating trials within 12 weeks of approval, with trial commencement defined as the first subject's signature of the informed consent form.
Review Process and Timeline Provisions
If the CDE (搜索)'s review of applications cannot be completed within the proposed 30 business days due to technical reasons, such as the need to consult with experts, the review will revert to the standard 60 business day timeline. The CDE will separately formulate and publish a list of required application materials for this special pathway.
China's Growing Position in Global Drug Development
The proposed policy changes occur as China demonstrates exceptional performance in new drug and biotech product development. Approximately one-third of global multinational corporation licensing deals now involve Chinese drugs in development. China's success stems from a large pool of scientific talent and the ability to initiate clinical trials more quickly than in Western markets.
The draft announcement represents China's continued efforts to enhance the efficiency of drug clinical trial review and approval processes. Public feedback on the proposed policy is due by July 16, 2025, after which the final announcement is expected to be issued.