Chang Lin-Chau, Gau Churn-Shiouh
1 Division of Pharmaceutical Science, Center for Drug Evaluation, Taipei, Taiwan.
2 Center for Drug Evaluation, Taipei, Taiwan.
Ther Innov Regul Sci. 2013 Nov;47(6):670-677. doi: 10.1177/2168479013495687.
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.
本研究旨在调查台湾提交的仿制药申请最终质量评估报告中列出的特点和缺陷。分析了2011年6月至2012年5月底提交的370份仿制药申请的基本信息，包括剂型、分类、原料药和产品生产场地位置，以及提交给台湾行政院卫生署食品药品管理局（TFDA）以供2012年9月底前做出最终决定的最终质量评估报告中列出的缺陷。统计分析表明，在生产方面有各种各样的提交内容。发现这些缺陷与美国食品药品管理局（FDA）和世界卫生组织（WHO）观察到的常见缺陷相似，同时欧洲药品管理局（EMA）也提到了一些问题。本文被认为是除了识别常见缺陷之外，第一份分析仿制药申请基本信息的报告。这些发现可以提供台湾仿制药申请提交情况和监管考量的概述，这对申请人编写档案可能有用，并有助于审批过程。
