Statistics, Quality Review Issues, and Beyond for Generic Drug Applications in Taiwan.

Abstract

The aim of the present study was to investigate the characteristics and deficiencies listed in the final quality assessment reports of generic drug applications submitted in Taiwan. The basic information of 370 generic drug applications submitted from June 2011 to the end of May 2012 was analyzed, including the dosage forms, classification, location of manufacturing sites of the drug substances and products, as well as deficiencies listed in the final quality assessment reports submitted to the Food and Drug Administration, Department of Health, Executive Yuan in Taiwan (TFDA) for final decisions before the end of September 2012. Statistical analysis demonstrated a variety of submissions concerning a manufacturing aspect. The deficiencies were found to be similar to common deficiencies observed by the US Food and Drug Administration (FDA) and the World Health Organization (WHO), while some issues were mentioned by the European Medicines Agency (EMA) as well. The present article is believed to be the first report to analyze the basic information of generic drug applications in addition to the identification of common deficiencies. These findings may provide an overview on the submissions and regulatory considerations for generic drug applications in Taiwan, which could be useful for applicants in the compilation of their dossiers and could facilitate the approval process.