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

  • check

    Quote and Ordar

  • check

    Timetable Schedule

  • check

    Report Launch

  • done

    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:2025-08-21 | 更新日期:2025-08-21

 

主旨:

 

有關本部研擬訂定「新興食品原料安全性評估作業原則」草案,第二次徵詢各界意見,請查照並轉知所屬。

 

說明:

 

一、為提供食品業者使用創新食品原料之評估程序,本部以維護國人飲食健康安全之前提下,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日發布修正指引,規範非傳統性食品原料之定義、審查機制、提出程序及安全性評估應提供之相關資料,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,本部研擬「新興食品原料安全性評估作業原則」草案,並已於114年3月13日公布於本部食品藥物管理署網站並函請各界提供意見。第一次徵詢意見期已截止,感謝各界提供之寶貴建議,本部參酌各界建議並經審慎綜合評估後,已酌修調整草案內容,第二版草案亦無涉及加嚴原指引要求,惟求周延,爰再次徵詢各界意見。

訂定「健康食品管理法所稱保健功效之項目」。

 

三、第二版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30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
1141302168-新興食品原料安全性評估作業原則(第二版草案)