About
MDG

Medgaea Life Sciences is a third party laboratory that is certificated for OECD GLP, TFDA GLP, ISO 17025 and ISO 9001. Maily based on preclinical CRO, we provide total-soltion services to assist biotechnology industries successfully obtain the product certification and exploit internation market.

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CRO

  • check

    Needs Discuss

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    Quote and Ordar

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    Timetable Schedule

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    Report Launch

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    Case Closed

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Services

With devoting to our core value 『Honesty•Accuracy•Professionalism•Responsibility』,

We have successfully assisted our customers to successfully obtain the product certification in FDA, CE, TFDA and NMPA.

Medical Devices

One of the first priority of medical devices R&D is their safety. The Biocompatibility test is mainly followed the ISO 10993 international standard.

Cell therapy and Regenerative medicine

We assist the safety, effectiveness tests during the R&D process of cell therapy product. All the tests are complied with GLP.

Pharmaceutical development

As the agent of SNBL in Taiwan, will help new drugs company to complete non-clinical trials in medium, large animals and primates in the research and development stage.

Agrochemical and Enviromental Agents

The agroculture products need to review their toxicological data in advance, and all the tests must be carried out in complies with GLP.

Chemical Substances

Providing the toxicological test information!
EPA acquired the test information as the core basis to evaluate the substance announcement.

Health Food/ Ingredients

Provide safety, efficacy and stability tests for food ingredients and health foods.

Registration

Provide registration services.

Pharmaceuticals

Provide batch examine for medicine release, including pyrogen, acute systemic toxicity and other tests.

Laboratory animals and Equipment

An agent and supplier based on research and development of animal experiments, providing import services for various disease model animals in research institutions.

| 發布日期:2025-03-13 | 更新日期:2025-03-13

 

主旨:

 

有關衛生福利部研擬訂定「新興食品原料安全性評估作業原則」草案,徵詢各界意見,請查照並轉知所屬。

 

依據:

 

行政程序法第一百五十一條第二項準用第一百五十四條第一項。

 

說明:

 

一、為評估非傳統性食品原料之安全性,衛生福利部(下稱本部)於102年6月24日公布「非傳統性食品原料申請作業指引(下稱原指引)」,並於107年5月10日發布修正,規範非傳統性食品原料之定義、安全性評估作業流程、須檢具之資料及表單等,以供有需求者提出,旨在以科學證據審慎評估,以保障消費者健康並兼顧產業發展。原指引公布於本部食品藥物管理署(下稱食藥署)網站,可由以下路徑查詢:首頁(http://www.fda.gov.tw)/便民服務/下載專區/食品申請作業及表單下載區/非傳統性食品原料申請作業指引。

 

二、為精進食品原料安全性評估作業,本部已研擬訂定「新興食品原料安全性評估作業原則」草案,針對原指引之內容文字、評估作業流程及應具備安全性資料等經常被詢問處,進一步清楚定義並詳盡說明,期能更有利於各界遵循。所擬草案內容並無涉及加嚴原指引要求,重點說明如下:

 

(一)修正原指引之相關名稱用詞及定義(含備註說明),以及安全性評估作業流程圖。

(二)更新原指引之相關安全性試驗資料說明,並新增動物福祉3Rs精神及原則。

(三)新增涉及以基因改造微生物生產製造之新興食品原料,應檢具之「以基因改造微生物生產但最終不含該微生物及轉殖基因之相關產品應備資料」及其審查流程。

 

三、旨揭草案請至食藥署網站「公告資訊」下「本署公告」網頁自行下載,對於草案內容有任何意見或建議者,請於本函發文日之次日起60日內提出意見或洽詢:

(一)承辦單位:衛生福利部食品藥物管理署
(二)地址:115021臺北市南港區研究院路一段130巷109號
(三)聯絡人:羅技術助理
(四)電話:(02) 2787-7318
(五)傳真:(02) 2653-1062
(六)電子郵件:yoannaluo@fda.gov.tw

 

檔案下載
1141300619-新興食品原料安全性評估作業原則(草案)