进口兽药注册资料技术评审意见函

经我中心组织专家评审，认为不符合新兽药注册有关技术要求，拟退审。
Upon technical evaluation by an expert panel organized by the center, it is decided that the product does not comply with relevant technical requirements for registration of new veterinary drug and is hereby rejected.

看了看农业农村部官网上的翻译，专家应该就是咱们常说的专家组，expert panel。

“拟退审”，应该就是驳回了，说的比较委婉。所以用了reject。

二、未提供处方筛选资料。
从降解杂质的结构看，主要杂质的产生是由于苯明西林的苄基（苯乙基）胺引起，处方配伍缺乏合理性。

2. No information on formulation screening is provided. In view of the structure of the degradation impurities, main impurities are due to benzyl (phenylethyl) amine of benestermycin. Therefore, the formulation is defective.

“处方筛选资料”不知道是啥？
“处方配伍缺乏合理性”，这个合理性，应该不能用rational或reasonable。个人理解是有缺陷，所以用defective，不知道对不对？

如 有异议，请在收到此函之日起5个工作日内，书面提交反馈意见 及相关技术资料；若需要与专家当面沟通和交流，应向我中心提出书面申请。
In the case of any objection, please submit feedback and relevant technical data within 5 working days upon receipt of this letter. If face-to-face exchange with the experts is desired, please file written application to the center.

沟通和交流应该用一个exchange就可以了。记得有本书里将，communication多指不涉及物品的交流，exchange多指有形物品的交流。这里exchange应该可以接受。