Abstract:
In 2018, Jiangsu province continued to rank first in the country in drug registration. Highlighted results were obtained from drug innovation, zero breakthrough was achieved in biological products, 6 of the 10 domestic innovative drugs approved for marketing nationwide were produced in Jiangsu. The consistency evaluation of the quality and efficacy of generic drugs was steadily advanced; the pilot project of Marketing Authorization Holders was gradually deepened; the shortage of clinical trial resources was effectively relieved. Recordation administration of the utilization of traditional techniques by medical institutions to prepare preparations was initiated on time. Revision of the specifications for processing prepared slices of Chinese crude drugs in Jiangsu province and the improvement of standards for preparations formulated by medical institutions had achieved initial success.