Taiwan

Taiwan

Taiwan Clinical Trial Registry

Verified on September 9, 2021

Taiwan has a clinical trial registry, Taiwan Clinical Trial Registry (TCTR) which has a provision to publish protocol registrations. TCTR is not a World Health Organization (WHO) recognized primary registry. The Taiwan Food and Drug Administration (TFDA) and Center for Drug Evaluation (CDE) are the regulatory bodies that maintain the Taiwan Clinical Trial Registry. Protocol registration in TCTR is voluntary, while there is no provision for results posting.

Registries at a Glance
Registry PHUSE Categorization Information to be Entered By Route of Data in Registry Study Type Language
Taiwan Clinical Trial Registry Mandatory National Database (includes Ethics Requirement) Sponsor Through a dedicated registration platform (process independent from clinical trial application)

Interventional

(Phase 1-4);

Observational

Chinese
Post-Marketing Study Registry Additional National Registry/Database (may be mandatory) Sponsor Through a dedicated registration platform (process independent from clinical trial application) Post-authorization Safety Efficacy Studies Chinese
English
Registration and Results Requirements
Registry Activity Legal Requirement Timing
Taiwan Clinical Trial Registry Registration

Yes

Prior to enrollment
Results

No

Not applicable (NA)
Post-Marketing Study Registry Registration

Yes

Prior to enrollment
Results

No

Not applicable (NA)

Registry Updates


  • May 2021: Taiwan Regulatory Update - The “Medical Devices Act” has come into effect from May 01, 2021. This act was announced on January 15, 2020 under the Presidential Decree. Taiwan Food and Drug Administration (TFDA) has amended the Pharmaceutical Affairs Act and stipulated a new law specifically for the management of medical devices. More information is available here.
  • March 2021: Taiwan Regulatory Update - The new “Medical Devices Act” is set to come into effect on May 01, 2021. This law was announced on January 15, 2020. Earlier medical devices were regulated by the Pharmaceutical Affairs Act, but now they will be part of the Medical Devices Act. Details about clinical trials on medical devices are included in Chapter IV, … Continue reading "March 2021: Taiwan Regulatory Update"
  • June 2020: Taiwan Regulatory Update - Applications for participating in TCP III is still being accepted June 30, 2020: Application for participating in the Technical Cooperation Programme, Version 3.0 (TCP III) on exchange of medical device quality management system(QMS) regulation and ISO 13485 audit reports is still being accepted. The submission of application for participating in the Technical cooperation Programme (TCP) … Continue reading "June 2020: Taiwan Regulatory Update"

References


  1. Clinical Trials in Taiwan – Part 2: Regulatory. http://blog.credevo.com/2017/03/02/clinical-trials-in-taiwan-part-2-regulatory/. Published on March 2, 2017. Accessed on November 6, 2018.
  2. Regulations for Good Clinical Practice. Taiwan Food and Drug Administration. https://www.fda.gov.tw/ENG/lawContent.aspx?cid=5060&id=3033. Published on October 23, 2014. Accessed on March 03, 2020.