The National Medical Products Administration (NMPA) has released its “Annual Drug Supervision and Administration Statistics (2022)”, offering insights into the drug and device administrative system for the 2022 calendar year.
Yearly Increase in Clinical Trials and Market Filings
During the period, the NMPA accepted a total of 2,403 clinical trial filings, marking a 1.6% year-on-year (YOY) increase; 3,714 market filings, up 14.2% YOY; and 5,892 supplementary market filings, up 3.7% YOY. These figures indicate a growing trend in the pharmaceutical and medical device sectors.
Domestic and Overseas Drug Approval Numbers
As of the end of 2022, there were 153,713 drug approval numbers produced domestically, up 1.8% YOY. In contrast, there were 2,998 approval numbers for overseas-manufactured drugs, down 35.2% YOY. Among these, 18 innovative drugs were approved for marketing, and 1,615 innovative product candidates were approved for clinical trials, showcasing the NMPA’s focus on fostering innovation in the pharmaceutical industry.
Medical Device Registrations and Decreases
The first registration of medical devices (registration certificate number) was 16,076, a decrease of 16.9% YOY. Except for domestic Class III medical devices, the first registration of domestic Class II medical devices and imported Class II and Class III medical devices also saw a decline.
Pharmaceutical Production Licenses and Drug Quality
As of the end of 2022, there were 7,974 companies with pharmaceutical production licenses across the country, a year-on-year increase of 6.6%. The total unqualified rate of national drug sampling batches in 2022 was 0.63%, higher than the 0.43% in 2021, indicating a slight increase in drug quality concerns.
Import Statistics and Key Importing Countries
In 2022, the amount of imported chemicals, traditional Chinese medicine, and biological products reached USD 15.61 billion, a year-on-year decrease of 17.14%. Ireland topped the list with the highest import amount, totaling USD 4.67 billion, an increase of 18% YOY. The United States followed with a total of USD 3.58 billion (+5%), and Germany ranked third with imports of USD 2.75 billion, a year-on-year decrease of 22%. Laos, Sri Lanka, Macau of China, and Turkmenistan emerged as new import sources.-Fineline Info & Tech
