The National Institute for Food and Drug Control (NIFDC) has released its “National Drug Sampling Inspection Annual Report (2023),” providing a comprehensive overview of the drug quality surveillance conducted in the past year. The report details the testing of 132 drug varieties, comprising 74 chemical drugs, 43 patented traditional Chinese medicines (TCMs), and 6 biologic products. Among these, 45 products were from the national Essential Drug List (EDL), impacting inspections across 1,114 manufacturers, 2,528 distributors, and 511 user entities.
The inspection process involved sampling 10,893 batches of 74 varieties of chemical drugs, with 10,864 batches complying with regulations and 44 batches failing. For biologic products, 127 batches of 6 varieties were sampled and inspected, including 5 therapeutic biologics and 1 preventative variety, achieving a 100% pass rate.
The report also highlighted the sampling of 6,140 batches of 39 EDL drugs (excluding Chinese herbal medicines), where 13 batches of non-compliant products were identified. Furthermore, 3,435 batches of 20 varieties involved in the national volume-based procurement (VBP) were sampled, all of which passed the tests, indicating a high standard of compliance in this sector.- Flcube.com
