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. There is no provision for results posting in TCTR.

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

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