The drug safety situation in the first half of the year was stable and good |

On July 12, the reporter learned from the recent National Drug Regulatory Symposium: In the first half of the year, the national drug safety situation was stable and the overseas new drug market was significantly accelerated. The nine-valent human papillomavirus (HPV) vaccine, 2. Sophorabate compound preparation, a variety of overseas new drugs such as PD-1 antibody, Navulitis monoclonal antibody injection for the treatment of malignant tumors were approved for marketing.

drug The review and approval time is further compressed, pending review Drug registration The application has dropped from 22,000 at the peak of 2015 to less than 3,200. Innovative drugs and medical instruments The review and approval was further accelerated. As of the end of June, a total of 29 batches of 597 drug registration applications were reviewed and approved, and 39 innovative medical devices and 4 priority medical device products were reviewed and approved.

In addition, the pilot system for listing license holders has been launched in depth. Since the pilot, there have been 178 clinical trial applications for pilot varieties, and 118 pilot varieties have been approved for marketing and supplement applications, greatly stimulating the enthusiasm of drug development and stimulating enterprise Innovative vitality, effectively reducing redundant construction, played a positive role in promoting structural reform of the drug supply side.

The evaluation of the quality and efficacy of generic drugs is also progressing steadily. At present, there are 15 batches of 1071 specifications for reference preparations, and a total of 4 batches of 41 generic drugs have passed the consistency evaluation.