Regulatory status of drug master file in Taiwan 2009–2011

The drug master file submission in Taiwan commenced on 1 October 2009 and is driven by the health reimbursed pricing system. To clarify the consequences of this policy, we focused on the applications for the initiation of the policy from overseas active pharmaceutical ingredient manufacturers, which were the majority of the total applications. Indian manufacturers filed the most drug master files, representing 44% of total overseas drug master files and accounting for the largest number of multiple drug master files with the same molecules. Antibacterial, cardiovascular, and psychiatric drugs were the main therapeutic categories for the submitted molecules. The acceptance rates in the original submission and the appeal/resubmission applications for Indian drug master files were 32 and 38%, respectively, comparable with the average of overall drug master file acceptance rates (30%, 38%) under corresponding conditions. The nonaccepted applications included 12% of drug master files that failed to provide the restricted part and 24% of drug master files that did not respond to deficiencies. The main deficiencies were associated with the manufacturing process, active pharmaceutical ingredient specification, starting material, material/intermediate, and analytical method/validation.