2017 Drug Review Annual Report Released

May 22, 2018
On March 23, 2018, CFDA issued the 2017 Drug Review Annual Report. Among them, the completion status of the review and approval of drug registration applications is as follows:
1. Approval of registration applications for marketing of drugs In 2017, CFDA approved 394 registration applications for marketing of drugs (in terms of drug approval numbers), which can be segmented into 369 chemical drugs, 2 TCM ethnic medicines (hereinafter referred to as TCMs), and 23 biological products; 278 domestic drugs and 116 imported drugs; 28 new chemical drugs, 1 new TCM, 10 biological products, 238 chemical generic drugs, and 1 generic TCM in terms of domestic drugs; 53 varieties were included in the priority review & approval, accounting for 13.5%.
2. Completion of review & approval in 2017 Pursuant to the CFDA's Decision on Adjusting the Administrative Review and Approval Procedures for Some Drugs (CFDA Order No. 31), based on its original technical review function, the Center for Drug Evaluation, CFDA (hereinafter referred to as CDE) undertakes three administrative review and approval decision-making functions for drug clinical trials, drug supplementary applications, and import registration renewal. In 2017, CDE completed a total of 9,680 registration applications (according to the application number, the same below) for review & approval, wherein 8,773 are registration applications with technical review, and 907 are direct administrative review and approval (without technical review, the same below). The number of registration applications pending for review has fallen from nearly 22,000 at the peak of September 2015 to 4,000 (excluding registration applications with completed review awaiting for applicants' supplementary information due to defects in application dossiers). The review & approval of TCMs, chemical drugs, biological products and other varieties of products basically met the statutory deadlines, and the work objectives set by Document No. 44 of the State Council to solve the backlog of drug registration applications, have been basically completed. The changes in the number of registration applications pending for review in 2014-2017 are detailed in Figure 1. Of the applications with completed review, 7,729 were registered for chemical drugs, accounting for about 88% in all.
3. Completion of review for various types of registration applications CDE completed review for 908 applications for clinical trials of Investigational New Drugs (INDs), 294 New Drug Applications (NDAs), 4,152 Abbreviated New Drug Applications (ANDAs) for marketing. 744 IND applications (involving 373 varieties) have been approved, 143 NDAs (involving 76 varieties) and 273 ANDAs (involving 123 varieties) have passed the review and are recommended for approval. Notes: The number of varieties of chemical drugs is based on the statistical analysis of active ingredients, while the number of varieties of TCMs and biological products are all reported under the generic names of drugs.