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2014-2019年臺灣申請學名藥農藥之概況分析

Overview of Me-Too Pesticide Registration in Taiwan between 2014 and 2019

摘要


本研究統計2014至2019年申請學名藥農藥案件,申請數量最多的是有機化學製劑(占98.3%),其餘則為無機鹽類製劑及生物農藥等。申請成品農藥案件數量依工廠所在國家統計,臺灣自製成品數量最多(占53.5%),其次則為越南進口(占32.7%)。申請成品農藥種類,以固殺草(glufosinate-ammonium)13.5%SL申請案件數最多(占2.3%),其次為亞托待克利(azoxystrobin+difenoconazole)32.5%SC(占2.2%)及百克敏(azoxystrobin)23.6%EC(占2.2%)。原體申請來源工廠主要來自中國(占80.8%),其次為印度(占12.9%),臺灣自製原體僅占2.3%。申請農藥原體以百克敏申請案件數最多(占4.4%),其次為固殺草(占4.1%)及亞托敏(占3.6%)。申請農藥原體符合等同性評估者占52.5%,不符合等同性者以必須再補繳致變異性試驗資料之類別最多。

並列摘要


This study counted applications of Me-Too pesticide registrations between 2014 and 2019. Organic chemical pesticides comprised the greatest proportion (98.3%) of Me-Too pesticide registrations, and the other 1.7% of registrations comprised inorganic salt and biological pesticides. In Taiwan, most Me-Too pesticide registrations (53.5%) were for domestically formulated agricultural pesticides, and pesticides imported from Vietnam accounted for 32.7% of Me-Too pesticide registrations. With regard to the application of specific types of formulated pesticides, glufosinate-ammonium 13.5% SL was the most applied (2.3%), followed by azoxystrobin + difenoconazole 32.5% SC (2.2%) and pyraclostrobin 23.6% EC (2.2%). The majority of technical (TC) grade pesticides imported to Taiwan were produced in China (80.8%), followed by India (12.9%), and 2.3% of TC were produced in Taiwan. Pyraclostrobin accounted for the largest number of applications (4.4%), followed by glufosinate-ammonium (4.1%), and azoxystrobin (3.6%). Results of an equivalence assessment for Me-Too technical grade pesticides indicated that equivalence was 52.5% and type I (mutagenicity testing) was the major category required for unequivalence.

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