Yuan Lin, Director of the Department of Drug Supervision of the State Food and Drug Administration, stated at the State Council’s policy briefing on July 8 that the State Food and Drug Administration continues to promote the reform of clinical trial management, optimize the review, review and approval mechanism, and a batch of obvious clinical trials. New drugs that are valuable and meet urgent clinical needs have been approved for marketing.
As of the end of June this year, a total of 766 applications for drug marketing registration had been approved, a year-on-year increase of 103%. Among them, 21 are innovative drugs and 139 are included in priority review. At the same time, on the basis of adhering to the principle of non-decreasing standards and categorized policy implementation, the efficiency of the evaluation of the quality and efficacy of generic drugs has also been steadily improved.
At present, 42 batches of reference preparation catalogues have been released, with a total of 4341 product specifications and 1848 varieties. As of the end of June this year, 569 varieties have passed or deemed to have passed the consistency evaluation.