NMPA Releases 2020 Annual Statistical Report: 7,690 Pharmaceutical Manufacturers, 1,096 Innovative Drug Clinical Candidates, and 128 Imported Drugs Approved for Market

This article was first published in EYi Manager and is republished here with authorization from VCBeat.

The 2020 Industry Performance Report Is Here! Today, the National Medical Products Administration (NMPA) released the Annual Statistical Report on Drug Supervision and Administration for 2020. The key data from the report are as follows: A total of 879 new drug clinical trial applications were approved, with only 9 being traditional Chinese medicine (TCM) and natural medicines. In 2020, the National NMPA approved a total of 879 new drug clinical trials (excluding imported drugs), including 9 TCM and natural medicines, 647 chemical drugs, and 223 biological products. Additionally, 181 clinical trial applications submitted under the new drug application procedure were approved, comprising 11 TCM and natural medicines, 97 chemical drugs, and 73 biological products.

 
604 Imported Drugs Approved for Clinical Trials

A total of 604 applications for imported drugs were approved for clinical trials, and 128 were approved for marketing. Among these, 380 chemical drugs were approved for clinical trials and 79 for marketing; 223 biological products were approved for clinical trials and 49 for marketing. Traditional Chinese medicines and natural medicines had the fewest approvals, with only one approved for clinical trials and none for marketing.

1,096 innovative drug candidates in clinical trials and 41 generic drug applications

In 2020, a total of 1,096 clinical trial applications for innovative drugs were approved, and 20 manufacturing applications for innovative drugs were approved. In the same year, 41 clinical trial applications for generic drugs were approved, along with 722 manufacturing applications.

842 GMP inspectors, including 275 with postgraduate degrees or higher

As of the end of 2020, there were 842 personnel qualified as Good Manufacturing Practice (GMP) inspectors for pharmaceuticals, all of whom were eligible to conduct inspections. In 2020, a total of 2,876 inspector-visits for pharmaceutical GMP inspections were carried out. Among these inspectors, 275 held master’s degrees or higher.

 
Up to 4,460 API and finished dosage form manufacturers

As of the end of 2020, there were 7,690 valid Drug Manufacturing Licenses nationwide in China (including those for traditional Chinese medicine decoction pieces, medical gases, etc.). By product category, 4,460 enterprises manufactured active pharmaceutical ingredients (APIs) and finished dosage forms; 3,519 enterprises produced chemical drugs; 2,160 enterprises produced proprietary Chinese medicines; 4,357 enterprises produced traditional Chinese medicines (including decoction pieces); 671 enterprises produced medical gases; and 224 enterprises produced special drugs.

Total R&D funding reached RMB 638 million, with successful technology transfer contracts amounting to RMB 5.383 million.

Scientific and technological funding for the national and provincial drug regulatory systems increased annually from RMB 350 million in 2011 to a total of RMB 638 million in 2020, of which RMB 356 million was allocated to project funding. A total of 2,163 scientific and technological projects were undertaken, including 261 soft science research projects. There were 31 achievements transferred, with the contract amount for achievement transfer fees totaling RMB 5.383 million.

319,200 retail chain enterprises and stores

As of the end of 2020, there were 573,300 enterprises in China holding a "Drug Operation License." Among them, there were 241,000 retail pharmacies, accounting for 42.03% of the total number of operating enterprises; 319,200 retail chain enterprises and stores, accounting for 55.68%; and 13,100 wholesale enterprises, accounting for 2.29%.

32 Drugs Transition to OTC Status

In 2020, the National Medical Products Administration (NMPA) reclassified 32 drugs from prescription to over-the-counter (OTC) status, including 6 chemical drugs and 26 traditional Chinese medicine products.

46 Cases of Counterfeit and Substandard Drugs Sold Online

In 2020, 4,561 cases involving the sale of counterfeit and substandard drugs were handled, with a total value of RMB 23.6927 million. Thirty-seven licenses were revoked, and 125 cases were transferred to judicial authorities. Among these, 46 cases involved online sales of counterfeit and substandard drugs, with a total value of RMB 455,000, fines amounting to RMB 1.3989 million, and 6 cases transferred to judicial authorities. There were 1,489 reports of fatal cases. In 2020, the National Center for ADR Monitoring received a total of 1.6758 million adverse drug reaction (ADR) reports, including 167,400 serious cases and 1,489 fatal cases. Ten ADR reports were processed.