Analysis of refuse-to-file policy for generic drug application in Taiwan

作者：Sun I Chen^*; Gau Churn Shiouh

来源：Regulatory Toxicology and Pharmacology, 2018, 94: 33-39.

DOI：10.1016/j.yrtph.2018.01.004

• Refuse-to-file
• Generic drug application
• Administrative information
• Chemistry
• Manufacturing and controls
• Bioequivalence
• Comparative dissolution profile

Generic drugs are accounted for majority of medicinal products. To reduce the unnecessary review for incomplete dossiers of generic drugs, Taiwanese government launched a refuse-to-file (RTF) process since 2017. The present study aimed to examine the outcome of RTF process by analyzing application characteristic, RTF rate and deficiencies found in the submitted dossiers. Descriptive analyses of administrative information, chemistry, manufacturing and controls, bioequivalence study, and comparative dissolution testing were presented during the first 6 months after the implementation of RTF policy. The results showed that the source of application was likely a determinant to the RTF outcome, i.e., foreign rather than domestic applications were more liable to be RTF. It is possibly that (i) RTF applications were mainly due to incomplete dossiers regarding bioequivalence study and comparative dissolution testing, and (ii) the studies (bioequivalence and dissolution) of domestic applications conducted locally are exempted from the RTF process because they are allowed to submit for review before generic drug applications. Finally, the dossier integrity appeared not improved during the period of analysis as the number of RTF did not reduce by month. Results of the present study may help pharmaceutical industry to improve the dossiers' quality by fixing the deficiencies of generic drug submission.

• 出版日期2018-4