To implement the directives of the CPC Central Committee and the State Council on accelerating the development of new quality productive forces and providing whole-chain support for the development of innovative drugs, the National Medical Products Administration (NMPA) organized a pilot program in 2024 to optimize the review and approval process for clinical trials of innovative drugs. To further implement the Opinions of the General Office of the State Council on Comprehensively Deepening the Reform of Regulation on Drugs and Medical Devices to Promote the High-Quality Development of the Pharmaceutical Industry ([2024] No. 53), the NMPA has concluded the experience from the pilot program and further optimizes the review and approval of clinical trials for innovative drugs. The details are hereby announced as follows:

I. To further support clinical value-oriented R&D of innovative drugs and enhance the quality and efficiency of clinical development, INDs for eligible innovative drugs will be reviewed and approved within 30 working days upon acceptance.

II. The 30-day clinical trial review and approval pathway supports national key R&D products, encourages early global synchronized development and international multi-center clinical trials, and serves urgent clinical needs and the development of the China's pharmaceutical industry.

III. INDs eligible for the 30-day pathway shall be Class I innovative drugs, including traditional Chinese medicines, chemical drugs, and biological products, and shall meet the submission requirements. In addition, one of the following conditions shall be met:

(I) Key innovative drugs with significant clinical value supported by national whole-chain innovation support policies.

(II) Eligible pediatric, rare disease, and traditional Chinese medicine innovative drugs published by the Center for Drug Evaluation of the NMPA.

(III) Globally synchronized development products, including: Phase-I and Phase-II clinical trials of globally synchronized development varieties; Phase-III MRCT-led or co-led by principal investigators from domestic clinical trial institutions.

IV. Before submitting an IND for the 30-day pathway, the applicant shall conduct a thorough assessment of the ethics review capabilities, qualifications, and compliance status of the leading clinical trial institution and its principal investigator, and collaborate with the lead clinical trial institution to synchronously initiate project establishment and ethics review. The applicant shall have risk assessment and management capabilities appropriate to the development risks of the submitted variety and commit to initiating the clinical trial within 12 weeks of approval. The specific requirements for the dossiers will be developed and issued by the Center for Drug Evaluation of the NMPA.

V. Applicants shall submit the IND to the Center for Drug Evaluation of the NMPA in accordance with the prescribed procedures and requirements, indicating the "30-day pathway" in the application form and providing corresponding documentation. The Center for Drug Evaluation shall conduct an acceptance review of the IND and issue a decision within 5 working days. If an application under the 30-day pathway cannot be reviewed and approved within the timeline due to complex technical issues, expert consultations, or meetings, the Center for Drug Evaluation will notify the applicant via the Applicant's Window within 20 working days after acceptance, and the overall review period will be extended to 60 days.

This Announcement shall come into force as of the date of issuance.

It is hereby announced.

National Medical Products Administration

September 09, 2025