Director of the National Medical Products Administration: Promoting the benign interaction between high-level drug safety and high-quality development of the pharmaceutical industry.

Li Li, the director of the National Medical Products Administration, pointed out in an article in the "Study Times" that it is necessary to continuously improve the quality and efficiency of drug evaluation and approval. Drug evaluation and approval is the "last mile" of drug research and development, as well as the "first mile" of drug marketing and application. It is a critical link in ensuring product quality from the source and accelerating the pace of new drug approval. It is important to ensure the standards of evaluation without relaxation and product quality with guarantees, while maximizing the compression of evaluation and approval time limits, reducing transaction costs for enterprises, and increasing the convenience of production and operation. Qualified clinically urgently needed products should be included in priority evaluation and approval procedures, with shortened time limits for technical evaluation, registration verification, and registration inspection to expedite the approval process. The implied approval time for clinical trials should be shortened, with the review and approval time for key innovative drug clinical trials further reduced from 60 working days to 30 working days. The drug supplementary application evaluation and approval process should be optimized, with pilot programs in certain provinces to provide pre-inspection services for post-marketing registration changes, significantly reducing the supplementary application evaluation time. Strictly following internationally recognized standards, the evaluation of generic drug quality and efficacy consistency should be conducted, carefully handling generic products without reference comparators. The consistency evaluation work should be expanded to other dosage forms beyond oral solid formulations and injections, continuously expanding the coverage of approved varieties, so that high quality and affordable drugs can benefit more patients.