OBJECTIVES : National price negotiations in China manage to improve affordability of drugs of high value in both money and clinic, and we intend to explore the implication of launch delay on their timely accessibility.

METHODS : We examined the launch delay of the chemical or biological drugs involved in the negotiations. Launch delay was defined as the gap days between the approval date of either the U.S. Food and Drug Administration (FDA) or the European Medicines Agency (EMA) and that of the China Center of Drug Evaluation (CDE), and we determined the launch delay of each indication covered by the medical insurance of every specific drug. Data were collected from the websites of FDA, EMA and CDE, and information from drug labels was also helpful.

RESULTS : In the 4 national price negotiations, 77 involved drugs yielded 101 approvals, and they underwent an average lag of 1945 days (5.32 years), ranging from 222 days to 7777 days. Based on the ATC category system, Antineoplastic and Immunomodulating agents accounted for more than the half, and they took the average of 1766 days to market in China after their launches in the U.S. or EU, while the category of Various sustained the most serious lag of 4454 days, and the Cardiovascular System experienced the shortest of 1288 days. 40 approvals were granted the special review channels, whose mean lag was 1626 days and shorter than the 2154 days for those rest on the standard procedure (P=0.0607). The Pearson correlation coefficient of the launch delay of the drugs and their each first launch date in EU or the U.S. was -0.5608 (P<0.0001), indicating the drug lag tended to be attenuated over time.

CONCLUSIONS : China is delayed seriously to access these medical innovations, and many efforts like establishing special review channels are conductive to improving this issue.