EMA新聞

來自專欄藥品註冊管理

19/06/2018

Modernising the orphan designation process

現代化的孤兒葯認定程序

EMA launches new submission portal today

今天，EMA建立新的申請門戶

The European Medicines Agency (EMA) has launched a new secure online portal fororphan designation

applications.

EMA已經建立新的，安全的在線門戶用於孤兒葯認定的申請。

The portal, named Iris, provides a single space where applicants can submit and manage the information and documents related to their applications for orphan designation. This is expected to reduce the time needed to prepare and submit the applications. During the review process, applicants can check the status of their applications from any device and receive automatic notifications when the status of the application changes.

該門戶叫做「Iris」，其提供單獨的區間，用於申請人遞交和管理與申請孤兒葯認定相關的信息和文件。以此希望減少申請準備和遞交的時間。在審核期間，申請狀態改變時，申請人可以從某些通道和接收的自動公告，來隨時查看申請進度。

Iris is part of a longer-term programme that aims to make the handling of product-related applications easier and utilises the domains of master data in pharmaceutical regulatory processes (SPOR).

Iris是長期項目的一部分，旨在使與產品相關的申請處理更加簡單，以及能使用藥品監管程序中涉及的主要數據的相關部分。

Applicants will still be able to use the existing submission process until 19 September 2018. However, the Agency strongly encourages companies to start using the new portal from today.

申請人可以一直按照現有程序進行申請直到2018.9.19,。然而，從今天開始機構將加大力度鼓勵公司開始使用新的門戶。

In order to help applicants with the transition, EMA has developed two guidance documents. These step-by-step guides provide detailed instructions on how to use the new system and explain what has changed with its introduction.

為了幫助申請人適應這種轉換，EMA發布兩個指導文件。這些文件提供詳細信息，手把手的教你如何使用新的系統，以及通過介紹而解釋該變換在哪裡。

EMA tested a pilot of the new system in March 2018 with 35 volunteers from 26 different organisations. Feedback from this test helped EMA to optimise the portal and showed high levels of satisfaction.

2018年3月，EMA招募35個來自26個不同組織的自願者測試新系統。該測試反饋能幫助EMA優化門戶和展示最優的層次。

In future, the new system may be extended to include other procedures, taking user feedback and experience into account.

未來，基於用戶的反饋與經驗，新系統可以擴展到其他程序。

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