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The history of clinical trials in Taiwan

1986

  • The Medical Care Act was promulgated and implemented. The Dept. of Pharmaceutical Affairs was responsible for IND review.

1989

  • Taiwan Cooperative Oncology Group (TCOG) was established.

1993

  • Announcement No. 8246232 of the Ministry of Health and Welfare, July 7, 1993 (referred to as the "July 7 Announcement") was announced. Domestic clinical trial report must be included in NDA application.

1996

  • Announcement of the Guidance for Industry: Good Clinical Practice (GCP).

1997

  • Joint Institutional Review Board (JIRB) was established.

  • Implementation of Taiwan GCP.

1998

  • Center for Drug Evaluation(CDE), Taiwan was established.

2000

  • The Department of Health began to encourage and support the establishment of general clinical research centers (GCRC) to coordinate the management of clinical trials throughout the hospital.

  • Announcement No.0890035812 of the Ministry of Health and Welfare, Dec 12, 2000 (referred to as the "Dec 12 Announcement) was announced. Bridging Study Evaluation mechanism was developed.

2003

  • IRB guidelines and accreditation were founded.

2005

  • Announcement of the Regulations for Good Clinical Practice.

2006

  • The Department of Health began to guide the domestic clinical trials to achieve higher study quality and standards by implementing the "Establish Outstanding Clinical Trial and Research System Program".

  • Taiwan Drug Clinical Trial Information platform was established.

2009

  • Announcement of Regulations on Human Trials.

2010

  • Taiwan Food and Drug Administration (TFDA) was established.

  • Announcement of Clinical Trial Notification (CTN).

2011

  • Announcement of Human Subjects Research Act.

2013

  • The establishment of the c-IRB Mechanism. The review process includes 20 days guaranteed main review and 10 days guaranteed sub review.

  • The Department of Health was upgraded to the Ministry of Health and Welfare.

2014

  • Taiwan Clinical Trials was established.