FDA发布细胞衍生动物用产品的最终行业指南

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FDA Issues Final Guidance for Industry on Cell-Based Products for AnimalUse

FDA发布细胞衍生动物用产品的最终行业指南

June 11, 2015

2015年06月11日

Today, the U.S. Food and Drug Administration issued a final Guidance for Industrydescribing the agency’s current thinking on cell-based products for animal usethat meet the definition of a new animal drug（反映了FDA在“满足新药定义的并基于细胞技术的动物用产品”的最新想法）. A cell-based product, including an animal stem cell-based product, that is intended to diagnose, cure, mitigate, treat, or prevent disease inanimals, or is intended to affect the structure or function of the animal,generally meets the definition of a new animal drug. （基于细胞技术的产品，包括动物干细胞衍生产品，即被用于诊断、治愈、缓解、治疗和预防动物疾病，或者影响动物的结构或者功能，一般满足新兽药的定义）

The final guidance updates the agency’s draft guidance by incorporatingfeedback from public comment. In particular, the final guidanceclarifies that it is directed at facilities and individuals manufacturing andmarketing such products, including animal stem cell-based products, for animaluse. Although it focuses on animal stem cell-based products meeting thedefinition of a new animal drug, this guidance also applies to other cell-basedproducts meeting the definition of a new animal drug.（最终指南澄清其目的在于针对生产或者销售该类动物用产品的厂家或个人，包括动物干细胞衍生产品。尽管该指南关注满足新兽药定义的动物干细胞衍生产品，同时该指南也同样适用于满足新兽药定义的其他细胞衍生产品）

The FDA is aware that many potential cell-based products may be produced asveterinary therapies. Developers of such products for animal use have asked howthe agency intends to regulate these products.（FDA意识到许多潜在的细胞衍生产品会被制造并用于动物治疗，该类动物用产品的开发者意呼吁FDA怎么对该类产品进行监管）

Cell-based products that meet the definition of a new animal drug aresubject to the same statutory and regulatory requirements as other new animaldrugs, including the requirements for current good manufacturing practices(cGMPs) and labeling. To be legally marketed, a new animal drug requires anapproved or conditionally approved new animal drug application (NADA) or index listing,unless it meets a statutory exemption. At this time, the FDA believes anapproved NADA will be the appropriate regulatory pathway for most cell-basedproducts.

满足新兽药定义的细胞衍生产品受制于与其他兽药产品相同的法规法律监管。包括cGMP的要求和标签管理。如果要合规上市，新兽药需要获得批准的或者限制性批准的（有条件批准的）NADA或者索引列表？？，除非其达到法规豁免。在现在，FDA认为通过发放批准的NADA将是对于细胞衍生药品的合适的监管方式。

This final guidance:

该最终版指南包括：

·        Clarifies FDA’s position that it hasjurisdiction over cell-based products meeting the definition of a new animaldrug;

清楚界定FDA在满足新兽药定义的细胞衍生药品的态度和司法管辖权。

·        Clarifies FDA’s current thinking onhow existing regulations apply to cell-based products;

澄明了FDA关于现存法规如何适用于细胞衍生产品的最新想法

·        Establishes a common vocabulary,including definitions, for cell-based products;

建立细胞衍生产品相关的通用词汇，包括定义。

·        Establishes a risk-based categorystructure for cell-based products; and

绘制了基于风险的细胞衍生产品的种类结构图。

·        Encourages industry to communicateand interact with FDA early in product development.

鼓励行业在产品开发前期积极和FDA进行沟通和配合。

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