FDA要求有關申請表格的更多信息 -這就是有利於創新和改善健康的原因

翻譯並整理：April

The FDA is Asking for More Information on Application Forms — Here』s Why That』s Good for Innovation and Improving Health

FDA要求有關申請表格的更多信息 -這就是有利於創新和改善健康的原因

Posted on May 4, 2018 by FDA Voice

發佈於 FDA之聲，2018.5.4

By: Christopher Leptak, M.D., Ph.D.

發布人：Christopher Leptak, M.D., Ph.D.

To be most effective, electronic health records (EHRs) use a systematized and standardized nomenclature for the hundreds of thousands of clinical terms that characterize patient care. This helps to ensure consistency from EHR to EHR and allows these records to be usable from healthcare entity to health care entity, a concept known as interoperability. This nomenclature, used by both industry and the federal government, is called SNOMED CT.

為了最有效，電子健康記錄（EHR）使用系統化和標準化的命名法來表徵患者護理的數十萬臨床術語。有助於確保從EHR到EHR的一致性，並且允許這些記錄從醫療實體到醫療實體可用，這一概念被稱為互操作性。該行業和聯邦政府都使用這種術語，稱為SNOMED CT。

Recognizing the value of such a comprehensive and standard clinical healthcare terminology, the FDA is also embracing the use of SNOMED CT to characterize disease names for its drug development pipeline and for FDA-approved products. The forms drug developers submit in their product applications now request use of this nomenclature. Forms for Investigational New Drugs (INDs) (FDA Form 1571) and New Drug Applications (NDAs), Biologic License Applications (BLAs) and Abbreviated New Drug Applications (ANDAs) (FDA Form 356h) have been revised to request additional supplemental systematized information using the SNOMED CT nomenclature to state for what disease or diseases the drug in the application is indicated.

認識到這樣一個全面和標準的臨床醫療術語的價值，FDA也正在採用SNOMED CT來為其藥物開發流程和FDA批准的產品描述疾病名稱。現在要求藥品開發商在其產品申請中所提交的表格使用該術語。臨床試驗新葯申請表（IND）（FDA表格1571）和新葯申請表（NDAs），生物許可證申請表（BLA）和簡化新葯申請表（FDA表格356h）已經修訂，要求使用額外的補充系統化信息 SNOMED CT命名法說明申請藥物是什麼疾病或疾病。

Here』s why the new nomenclature is good for innovation and improved health: By clearly identifying the intended uses or indications for a potential new drug, SNOMED CT enabled metrics will better inform review activities and aid in consistency in the FDA advice for applications with similar indications. Newly systematized indication information will allow the FDA to better identify areas of unmet medical need for future drug development. This information will also help inform policy development, and with it, allow FDA to become more proactive about developing guidances and gathering public feedback. Additionally, using SNOMED CT will make it possible for the FDA to link its internal data with other data sources coded to SNOMED CT (e.g., EHRs).

這就是為什麼新的命名法有利於創新和改善健康：通過清楚地確定潛在新葯的預期用途或適應症，SNOMED CT支持的指標將更好地為評估活動提供信息，並有助於FDA對類似適應症的申請建議保持一致。新的系統化指示信息將使FDA能夠更好地確定未來藥物開發未得到滿足的醫療需求領域。這些信息還將有助於制定政策，並使FDA能夠更積極地制定指導方針和收集公眾意見。此外，使用SNOMED CT將使FDA有可能將其內部數據與編碼為SNOMED CT的其他數據源（例如EHR）相關聯。

To help industry understand what to do, we just released an online tutorial for industry explaining the newly revised forms in detail.

為了幫助行業了解，應該做些什麼，我們剛剛發布了一個行業在線教程，詳細解釋新修訂的表格。

We look forward to working closely with industry to make sure applicants understand the revised forms and how to fill them out. We encourage industry to watch the tutorial, learn the coding system, and partner with the FDA on improving public health.

我們期待與業界密切合作，確保申請人了解修改後的表格以及如何填寫表格。 我們鼓勵行業觀看教程，學習編碼系統，並與FDA合作改善公共健康。

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本文值得關註：

1.SNOMED CT. (Systematized Nomenclature of Medicine -- Clinical Terms)醫學系統命名法-臨床術語，是當前國際上廣為使用的一種臨床醫學術語標準。同時也是美國聯邦政府指定的一套數據標準之一，旨在用於臨床信息的電子交換。

2. online tutorial在線教程網址：https://www.fda.gov/Drugs/DevelopmentApprovalProcess/SmallBusinessAssistance/ucm606366.htm

點擊該網址可以發現幾個重點問題：

On May 4th, FDA updated FDA Forms 1571 and 356h. We are making available this accompanying webinar which provides a description of the latest updates to the FDA』s Forms 356h and 1571 released in May 2018. These changes include identifying if the product is a Commercial IND or Research IND, the identification of Combination Products, and the inclusion of the Systematized Nomenclature of Medicine Clinical Terms (SNOMED CT).

FDA於5月4日更新FDA表格1571和356h。我們正在提供此次網路研討會，其中介紹了2018年5月發布的FDA的Forms 356h和1571的最新更新。這些更改包括確定產品是Commercial IND還是Research IND，組合產品的標識以及 納入醫學臨床術語系統化命名法（SNOMED CT）。

最新更新的申請表格356h和1571可以在FDA網站上獲得，此處不在贅述。

如果想獲得相關信息也可以聯繫我們，謝謝！

原文來源於：國際藥品註冊網&廣州佳鑫醫藥科技有限公司

本譯文著作權歸作者所有，非經作者或國際藥品註冊網授權，不得轉載。