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農藥原藥5批次全分析報告作為登記提交時最重要的資料之一，已成為企業在多個國家申請原藥等同或相同認定時的一項重要判定依據。瑞旭集團在此總結了歐盟，澳大利亞、美國以及中國對于農藥原藥五批次全分析試驗樣品和報告的要求，所需遵循的試驗準則，以及進行等同判定的參考來源依據。希望企業在開展五批次全分析試驗之前能按照各個國家對五批次報告的要求和規范來準備樣品和試驗，以便從源頭上獲得符合各個國家要求的全分析報告。
1. 對報告和樣品的要求
國家 | 報告和樣品要求 |
| 中國 | 申請人自行研制的成熟定型的5批次有代表性的原藥。 |
歐盟 | 應提交五年內由工業規模生產的五個代表性批次的樣品的分析報告。 如果不能提供最近五年的生產數據，則應提供理由或補充數據。 若提供的樣品來自中試生產系統，則等工業規模生產方法和程序穩定后，企業應再次提供所需信息。 |
澳大利亞 | 應提交五年內由工業規模生產的至少五個代表性批次的樣品的分析報告。 如果不能提供工業規模生產的批次數據，應該使用與工業規模制造工藝類似的中試樣品進行批次分析。 實驗室規模的批次樣品是不合適的，因為它們不能代表工業規模生產批次。 |
美國 | 具有代表性的5個批次（如果是批量生產）或5個（如果是連續生產）的樣品。 |
2. 試驗準則
國家 | 試驗準則 |
| 中國 | NYT 2886-2016 農藥登記原藥全組分分析試驗指南 |
歐盟 | SANCO/3030/99 |
澳大利亞 | 農藥資料準則 |
美國 | OPPTS 830.1700 |
3. 參考來源有效成分含量規定
國家 | 參考來源有效成分含量規定 |
| 中國 | 參考已經登記產品及相應產品的國家標準 |
歐盟 | (EU) No 540-2011批準有效成分清單 |
澳大利亞 | 農藥和獸藥化學（農藥）標準 Agricultural and Veterinary Chemicals Code (Agricultural) Standard |
美國 | 參考已經登記產品 |
4. 試驗內容
國家 | 主要試驗內容 |
| 中國 | 有效成分、相關雜質和含量≥0.1%的其他雜質的定性和定量分析。 |
歐盟 | 對有效成分和每種含量≥0.1%的雜質，以及任何相關雜質進行定性和定量分析以確定原藥組成（包括有效成分和惰性組成）。 |
澳大利亞 | |
美國 |
一份合格的原藥五批次試驗報告是申請發達國家原藥登記成功的開端，五批次的分析結果對于原藥產品是否能被判定為等同或相同產品具有重要的意義，所以希望企業重視五批次試驗，為產品順利取得登記打下良好的基礎。
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