預告修正「健康食品申請許可辦法」草案。 - MDG麥德凱

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.

CRO

Needs Discuss
Quote and Ordar
Timetable Schedule
Report Launch
Case Closed

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.

主旨：

預告修正「健康食品申請許可辦法」草案。

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。

公告事項：

一、修正機關：衛生福利部。

二、修正依據：健康食品管理法第七條第五項。

三、「健康食品申請許可辦法」修正草案總說明及條文對照表如附件。本案另載於行政院公報資訊網、本部網站「衛生福利法規檢索系統」網站 (https://mohwlaw.mohw.gov.tw/)下「法規草案」網頁、本部食品藥物管理署網站(https://mohwlaw.mohw.gov.tw/)「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：115021臺北市南港區研究院路一段130巷109號

(三)電話：（02）2787-7332

(四)傳真：（02）2653-1062

(五)電子郵件：fan@fda.gov.tw

檔案下載
健康食品申請許可辦法修正草案總說明及條文對照表
 預告修正健康食品申請許可辦法草案公告