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FDA:更新紫皮书

FDA 紫皮书(已批准生物制品数据库)更新
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文章来源:JULIAJulia法规翻译

Updates to the Purple Book: Database of Licensed Biological Products

紫皮书(已批准生物制品数据库)更新
Today, FDA made updates to thePurple Book: Database of Licensed Biological Products(Purple Book) to publish patent lists that reference product sponsors have provided for certain licensed biological products.
今天,FDA 更新了紫皮书(许可生物产品数据库),在其中发布参比药品申办人为某些已批准生物产品提供的专利列表。
https://purplebooksearch.fda.gov/
Among other things, the Biological Product Patent Transparency (BPPT) section of the Consolidated Appropriations Act of 2021 requires publication of patent lists provided by reference product sponsors (i.e., biologics license application (BLA) holders) to FDA for certain licensed biological products. Specifically, a reference product sponsor is required to provide to FDA the list of patents and corresponding expiry dates, not later than 30 days after the reference product sponsor has provided the initial list to a 351(k) applicant under section 351(l)(3)(A) or (l)(7) of the Public Health Service (PHS) Act. The reference product sponsor is also required to provide to FDA any subsequent or supplemental lists, and their corresponding expiry dates, within 30 days of the provision of such lists to a 351(k) applicant under section 351(l)(3)(A) or (l)(7) of the PHS Act.
2021 年综合拨款法案的生物产品专利透明度 (BPPT) 部分要求公布参比药品申办人赞助商(即生物产品许可申请 (BLA) 持有人)向 FDA 提供的某些获得许可的生物产品的专利清单。具体来说,参比药品申办人必须根据PHS第351(l)(3)(A)条或 (l)(7)条,在提供初始清单后 30 天内向 351(k) 申请人向 FDA 提供专利清单和相应的到期日。根据PHS第351(l)(3)(A)条或 (l)(7)条规定,参比药品申办人在向 351(k) 申请人提供此类清单后 30 天内,还需要向 FDA 提供任何后续或补充清单及其相应的到期日期。
FDA‘s role in publishing patent information is ministerial, and FDA does not consider the applicability of patents to a biosimilar product (e.g., validity, enforceability, or potential infringement) in publishing the information described in section 351(k)(9) of the PHS Act, nor in FDA’s review of a 351(k) BLA or supplement to a 351(k) BLA. For additional information regarding Purple Book listing requirements, seeFAQ 5. For detailed information regarding submission processes for initial and updated patent information, seeFAQ 6andFAQ 7, respectively.
FDA 在公布专利信息方面的作用是管理作用,并且 FDA 在公布PHS第 351(k)(9) 节中描述的信息时不考虑专利对生物类似物产品的适用性(例如,有效性、可执行性或潜在侵权),这些内容亦不在FDA 对 351(k) BLA 或 351(k) BLA 补充的审查中。有关紫皮书列表要求的其他信息,请参阅常见问题 5。有关初始和更新专利信息的提交流程的详细信息,请分别参阅常见问题 6 和常见问题 7。
ThePurple Bookdatabase contains information about all FDA-licensed biological products, including licensed biosimilar and interchangeable products, and their reference products, and information on all FDA-licensed allergenic, cellular and gene therapy, hematologic, and vaccine products. The Purple Book is intended to improve transparency and functionality for stakeholders by providing a complete view of biological product options.
紫皮书数据库包含有关所有 FDA 许可的生物产品的信息,包括许可的生物仿制药和可互换产品及其参考产品,以及所有 FDA 许可的过敏原、细胞和基因治疗、血液和疫苗产品的信息。紫皮书旨在通过提供可选生物产品的全面视角来提高利益相关者的透明度和功能。
FDA:更新紫皮书

发布于 2021-07-02 10:43:09 © 著作权归作者所有
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