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Chris Wu
   Hills Consulting

Registration consultant. Worked in National Polar Research Center, Syngenta and Yongnong. Now Technical Director in Hills Consulting. Email: 705478130@qq.com, Skype: chriskangwu

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  • Brazilian registration discussion: how to accelerate PTE registration & client and competition   2018-10-09

    Back to complex Brazilian issues, did not remember when, Anvisa phase II evaluation started to follow the so called icy beauty EU Sanco 10597 principle. Complete Acute six and mutagenicity two is no longer a standard request and replaced by more scientific tiered approaches that based on phase I analysis result, QSAR, Ames and (others when considered needed), are requested accordingly, and alternative in-vitro test is preferable than in-vivo. Thinking about the Chinese new registration regulations, yes all the authorities are improving; life is getting better for us and the animals. BUT in Brazil still suffered from the big number of the queue for Technical Equivalence Process, so called PTE, more than 1000. What approaches can be done to accelerate PTE registration?

    Back to complex Brazilian issues, did not remember when, Anvisa phase II evaluation started to follow the so called icy beauty EU Sanco 10597 principle. Complete Acute six and mutagenicity two is no longer a standard request and replaced by more scientific tiered approaches that based on phase I analysis result, QSAR, Ames and (others when considered needed), are requested accordingly, and alternative in-vitro test is preferable than in-vivo. Thinking about the Chinese new registration regulations, yes all the authorities are improving; life is getting better for us and the animals. BUT in Brazil still suffered from the big number of the queue for Technical Equivalence Process, so called PTE, more than 1000. What approaches can be done to accelerate PTE registration?

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