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The Medical Care Act
- Medical Care Act (Amended on May 10, 2017) [Chinese]
- Medical Care Act (Amended on May 10, 2017) [English]
- 醫療法施行細則 (99.03.12修正)
Regulations on Human Trials
- Download
- Regulations on Human Trials (Amended on April 14, 2016) [Chinese]
- Regulations on Human Trials (Amended on April 14, 2016) [English]
Pharmaceutical Affairs Act
- Pharmaceutical Affairs Act (Amended on June 14, 2017) [Chinese]
- Pharmaceutical Affairs Act (Amended on June 14, 2017) [English]
- Pharmaceutical Affairs Act Enforcement Rules (Amended on September 28, 2016) [Chinese]
- Pharmaceutical Affairs Act Enforcement Rules (Amended on September 28, 2016) [English]
- Pharmacists Act (Amended on July 16, 2014) [Chinese]
- Pharmacists Act (Amended on July 16, 2014) [English]
- 藥師法施行細則 (98.03.05修正)
Good Clinical Practice
- Regulations for Good Clinical Practice (Amended on October 23, 2014) [Chinese]
- Regulations for Good Clinical Practice (Amended on October 23, 2014) [English]
Human Research Act
- Human Subjects Research Act (Announced on December 28, 2011) [Chinese]
- Human Subjects Research Act (Announced on December 28, 2011) [English]
- 倫理審查委員會得簡易程序審查之人體研究案件範圍 (101.07.05)
- 得免取得研究對象同意之人體研究案件範圍 (101.07.05)
- 得免倫理審查委員會審查之人體研究案件範圍 (101.07.05)
Guidelines for Collection and Use of Human Specimens for Research
Human Biobank Management Act
- Human Biobank Management Act (Amended on August 08, 2012) [Chinese]
- Human Biobank Management Act (Amended on August 08, 2012) [English]
Personal Information Protection Act
- Personal Information Protection Act (Amended on December 30, 2015) [Chinese]
- Personal Information Protection Act (Amended on December 30, 2015) [English]
- Enforcement Rules of the Personal Information Protection Act (Amended on March 2, 2016) [Chinese]
- Enforcement Rules of the Personal Information Protection Act (Amended on March 2, 2016) [English]
Other Guidelines and Regulations
- The Belmont Report (貝蒙報告) (April 18, 1979)
- Declaration of Helsinki (赫爾辛基宣言) (October 2013) [Chinese]
- Declaration of Helsinki (赫爾辛基宣言) (October 2013) [English]
- Nuremberg Code (紐倫堡宣言) (1947)
- Declaration of Taipei (世界醫師會台北宣言) (October 22, 2016)
- Guidance for Industry - E6 Good Clinical Practice Consolidated Guidance (April 1996)
- 臨床試驗受試者招募原則 (96.06.06)
- Regulations Governing the Organization and Operational Management of the Institutional Review Board for Human Subject Research (Announced on August 17, 2012) [Chinese]
- Regulations Governing the Organization and Operational Management of the Institutional Review Board for Human Subject Research (Announced on August 17, 2012) [English]
- Regulation for Registration of Medical Devices (Amended on March 30, 2017) [Chinese]
- Regulation for Registration of Medical Devices (Amended on March 30, 2017) [English]
- 人體研究計畫諮詢取得原住民族同意與約定商業利益及其應用辦法 (106.03.14修正)
