Cde.org.tw

  1. Home
  2. Cde.org.tw

Center for Drug Evaluation, Taiwan

WEBThe Bridging Study Evaluation is to evaluate whether foreign clinical trial data can be extrapolated to the corresponding population in Taiwan (or east-Asian), then making a …

Actived: 3 days ago

URL: https://www.cde.org.tw/eng/drugs/

Center for Drug Evaluation, Taiwan

WEBAccording to Article 78 of the Medical Care Act and Article 7 of the Regulation of Bioavailability and Bioequivalence Studies, an applicant can conduct a domestic BA or …

Category:  Medical Go Health

Center for Drug Evaluation, Taiwan

WEBIND applications should meet the requirements set forth in the Notices for the Application of Clinical Trials announced by Taiwan Food and Drug Administration (TFDA) of the …

Category:  Food Go Health

Center for Drug Evaluation, Taiwan

WEBThe Center for Drug Evaluation (CDE) was established by the Department of Health (now the Ministry of Health and Welfare, MOHW) on July 13th, 1998. The purpose of the CDE …

Category:  Health Go Health

Center for Drug Evaluation, Taiwan

WEBThe Prospect of HTA in Taiwan. The CDE established the Division of Health Technology Assessment in 2007 to continue its promotion of HTA in Taiwan. Since then, HTA, a …

Category:  Health Go Health

Center for Drug Evaluation, Taiwan

WEBThe CDE established the HTA team on April 1, 2008. The main task of the HTA team is to perform scientifically-based assessment, as commissioned by the competent authority, …

Category:  Health Go Health

Center for Drug Evaluation, Taiwan

WEBDescription. CDE’s Procedure for handling of applications for HTA advisory services. The consultation service provided by the HTA division of CDE is primarily to answer …

Category:  Health Go Health

Center for Drug Evaluation, Taiwan

WEB1. According to Article 22-1 of the Regulations for Registration of Medicinal Products, the following drug items are regarded as requiring a bridging study evaluation： (1) New …

Category:  Health Go Health

Center for Drug Evaluation, Taiwan

WEBThe information and requirements for drug registration are described in the regulation. According to Subparagraph 2, Paragraph 1, Article 4 of the Regulations for Registration …

Category:  Health Go Health

歡迎光臨財團法人醫藥品查驗中心-醫藥科技評估簡介

WEB“HTA is the systematic evaluation of properties, effects, and/or impacts of health technology. Its main purpose is to inform technology-related policy-making in health …

Category:  Health Go Health

Center for Drug Evaluation, Taiwan

WEBThe Center for Drug Evaluation (CDE) was established by the Department of Health (now the Ministry of Health and Welfare, MOHW) on July 13th, 1998. The purpose of the CDE …

Category:  Health Go Health

Center for Drug Evaluation, Taiwan

WEB1. An applicant shall submit an NDA application with the following documents: (1) The Form A and the Form B (Please refer to the announcement No. 1001405584 issued on …

Category:  Health Go Health

Center for Drug Evaluation, Taiwan

WEB1. For the DMF post-approval changes, an applicant shall submit an application in accordance with Article 49-1 and Appendix 12 of the Regulations for Registration of …

Category:  Health Go Health

歡迎光臨財團法人醫藥品查驗中心-HTR醫療科技再評估

WEB2013 年 1 月 16 日衛生福利部參考國際上各國醫療科技評估相關組織之功能及定位，以及考量實際運作之可行性，規劃分階段逐步整合衛生政策、醫療服務、資源合理配置等科技 …

Category:  Health Go Health

健保署、CDE與英國 NICE 簽署合作協定，展現台灣醫療科技評 …

WEB因應創新與嶄新科技、多方的利害關係人與大眾期望，如何在有限的健保資源下，讓資源花在刀口上，以實證為基礎，協助提升創新藥品病人用藥可近性，全球的 …

Category:  Health Go Health

何謂醫療科技評估？

WEB何謂醫療科技評估？. 醫療科技評估 (HTA)是系統性的探討使用醫療科技與設備，在操作性能、治療效果、財務衝擊、醫療倫理等各方面所產生的影響；HTA的評估架構是借鑒多元 …

Category:  Health Go Health

日本醫療科技評估之初探

WEBRegMed 2021 Vol. 133 3 且新品項的給付價格，會與比較品設有相同的價格；對於沒有適當比較品的品項，將採 用成本計算方法，主要是根據製造、研發、行政、行銷成本，及營 …

Category:  Health Go Health

美國 FDA 於 2021 年 12 月發表「臨床研究中使用數位醫療科 …

WEBRegMed 2022 Vol. 139 42. 美國FDA 於2021 年12 月發表「臨床研究中使用數位醫療科技 執行遠端資料蒐集」指引草案. 發表單位： 美國FDA 摘要整理： 林祐薇 發表時間： …

Category:  Health Go Health

Top Categories

 › Appendicitis

 › Headaches

 › Gout

 › Women's Health

 › Thyroid

 › Sleep

 › Skin

 › Sexual Health

 › Senior Health

 › Pregnancy

 › Oral Health

 › Neurology

 › Migraine

 › Mental Health

 › Men's Health

 › Menopause

 › Medications

 › Lung Conditions

 › Infectious Disease

 › HIV/AIDS

Popular Searched

 › Mental health jobs in michigan

 › Sport and health northwest

 › Soft drinks and health

 › Health inequality data tool

 › Advent health track shack 2023

 › Legacy health service work from home

 › National adaptation plan health

 › Lhc conemaugh home health

 › Senior home health bedford pa

 › Utm mental health resources

Recently Searched

 › Healthcare system overview in united states

 › Health literacy and patient outcomes

 › Avant healthcare professionals careers

 › Can nutrition affect mental health

 › Kansas health information network network

 › Health care proxy limitations

 › Kansas health information network qhins

 › Baptist health primary care portal

 › Unity health care pay bill online

 › Prohealth breast cancer center