On March 31st,the Drug Approval Center of the State Food and Drug Administration issued a notice on the "Standards for Accelerating the Evaluation of Innovative Drug Marketing License Applications by the Drug Approval Center (Trial)". This specification combines the experience of emergency review in the process of epidemic resistance, encourages the innovative research and development process of children's drug and rare disease drug, and is a powerful measure to speed up the review and approval of innovative drugs.

The scope of the standards application is mainly innovative drugs for children, innovative drugs for treating rare disease and innovative drugs that incorporate the breakthrough therapy drug procedures. The applicable stage is when the applicant has met the conditions for conducting confirmatory clinical trials after the completion of exploratory clinical trials and before approval for marketing. Carry out communication, exchange, review and approval work in accordance with regulations. Applicants applying for listing should submit priority review and approval applications as required while submitting the drug marketing license; the time limit for communication is 30 days, and the time limit for variety evaluation is 130 days, which is the same as the time limit for priority evaluation of varieties. The workflow is as follows:

1) Get involved in early stage, which includes five aspects: early establishment of a review team, continuous promotion of communication, active implementation of research and review linkage, determination of rolling submission plans, and prioritization of verification and inspection work.

2) Acceptance and task assignment. Propose requirements for the early intervention, coordination, and guidance of the acceptance personnel of the Drug Approval Center to ensure the smooth progress of the acceptance and evaluation work.

3) Verification and inspection. Mainly including registration inspection and verification.

4) Professional review.

5) Comprehensive review.

6) Sign and issue, and deliver to the bureau.