药政注册

Regulatory Affairs


汉维拥有一支有10年以上国际药政注册经验的药政注册团队,经过7年努力,迄今为止汉维共获得6项国家新药证书,跻身成为中国拥有宠物类新药证书最多的公司。
新药产品申报需要汉维对产品不断的研究开发、工艺优化、生产探索,并且经过权威机构对于产品进行药物代谢动力学、临床药效学、动物安全性试验的反复研究和论证,从而确保的产品能够符合安全、有效、质量可控等要素。每个新药证书和批准文号都是汉维多年的不断研究、努力付出的结晶,让客户使用上具有国家正规批准文号的放心产品,是汉维一直以来不懈努力的追求。

In past 7 years, Hanvet’s experienced Regulatory Affairs team has been obtaining more than 6 New Drugs Certificates in China, which made Hisun to be the holder holding the most New Drug Certificate in China for companion animal healthcare products.
All the New Drug Certificate required Hanvet’s effort for the R&D, process study and manufacturing study. More than that, all New Drug in China required complete trials of Pharmacokinetics, Efficacy study, Safety study, performed by authorized university or institute, in order to ensure the safety, effect and quality assurance. To make customers use regulated and reassured products is Hanvet’s persistent pursuit.
Apart from domestic registration, Hanvet is also working for international projects’ registration work. If customer has intention to register their own products in China, Hanvet is willing to cooperate together with customer for the marketing and registration analysis. To further step, Hanvet’s professional Regulatory Affairs team will organize the registration according to Chinese Import Drugs application guideline.
Besides of basic documentation preparation, Hanvet is capable to organize registration relative studies:

o Toxicity study
o Pharmacokinetics study
o Efficacy study
o Residue study
o Target animal safety study

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