serach

   Honesty•Accuracy

Professionalism•Responsibility

   Honesty•Accuracy

Professionalism•Responsibility

Honesty•Accuracy•Professionalism•Responsibility

Core Value

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.

預告訂定「以基因改造畢赤酵母菌(Pichia pastoris) Ey72菌株發酵生產之食品原料小孢子靈芝類球蛋白濃縮液(Ganoderma microsporum globulin-like protein concentrate)之使用限制及標示規定」草案

發文日期：中華民國110年9月15日

發文字號：衛授食字第1101301978號

 

附件

「以基因改造畢赤酵母菌(Pichia pastoris) Ey72菌株發酵生產之食品原料小孢子靈芝類球蛋白濃縮液(Ganoderma microsporum globulin-like protein concentrate)之使用限制及標示規定」草案總說明及逐點說明之pdf檔各1份

 

主旨

預告訂定「以基因改造畢赤酵母菌(Pichia pastoris) Ey72菌株發酵生產之食品原料小孢子靈芝類球蛋白濃縮液(Ganoderma microsporum globulin-like protein concentrate)之使用限制及標示規定」草案。

 

依據

行政程序法第一百五十四條第一項。

 

公告事項

一、 訂定機關：衛生福利部。
二、 訂定依據：食品安全衛生管理法第十五條之一第二項及第二十二條第一項第十款。
三、 「以基因改造畢赤酵母菌(Pichia pastoris) Ey72菌株發酵生產之食品原料小孢子靈芝類球蛋白濃縮液(Ganoderma microsporum globulin-like protein concentrate)之使用限制及標示規定」草案如附件。本案另載於本部網站「衛生福利法規檢索系統」(https://mohwlaw.mohw.gov.tw/)下「法規草案」網頁、本部食品藥物管理署網站「公告資訊」下「本署公告」網頁及國家發展委員會「公共政策網路參與平臺─眾開講」網頁 (https://join.gov.tw/policies/)。
四、 對於本公告內容有任何意見或修正建議者，請於本公告刊登公報之次日起60日內陳述意見或洽詢：
(一) 承辦單位：衛生福利部食品藥物管理署
(二) 地址：115-61 臺北市南港區昆陽街161-2號
(三) 電話：(02)2787-7319
(四) 傳真：(02)2653-1062
(五) 電子郵件：tzuyi@fda.gov.tw

 

 

檔案下載
1101301978-公告掃描檔(110.9.15公告)
1101301978-草案總說明(110.9.15公告)
1101301978-草案逐點說明(110.9.15公告)