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Making Registration Systems Work For Generics

机译:使注册系统适用于泛型

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摘要

PESTICIDE registration systems must not only ensure the quality of approved crop protection products and their reasonable safety regarding human health, the environment and crops, they must also be efficient in approving generics. Due to a decline inR&D productivity in the generation of research companies during the last two decades, along with extensive patent expirations, registration authorities are likely to receive many times more submissions for the approval of generics than for new chemical entities.
机译:农药注册系统不仅必须确保批准的作物保护产品的质量及其在人类健康,环境和农作物方面的合理安全性,而且还必须有效地批准仿制药。由于过去二十年来研究型企业的研发生产率下降,加上专利期满,与非新化学实体相比,注册机构收到的仿制药批准申请可能要多很多倍。

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