Regulatory scenario & approval process for clinical trials in Taiwan

Taiwan offers a supportive and efficient regulatory landscape for clinical trials, primarily managed by the Taiwan Food and Drug Administration (TFDA). The TFDA simplifies the approval process and provides expedited reviews for innovative therapies, allowing studies to start more quickly. With its advanced healthcare facilities and diverse patient population, Taiwan has become an attractive destination for clinical research.

Taiwan is emerging as a big player in the Asian clinical trial market. Taiwan has many advantages for conducting clinical trials. Refer to Part 1 of this blog for more details.

In this part, let’s talk a bit about the clinical trial regulatory scenario in Taiwan, including the approvals required and how to be prepared for it.

Clinical trial approval

The Taiwan Food and Drug Administration (TFDA) with assistance from the Center for Drug Evaluation (CDE), handles applications of new drugs, medical devices, and clinical trials to fulfill regulatory requirements in line with international norms.

Most of the essential documents, including the Chemistry, Manufacturing, and Controls (CMC) section of investigational new drugs (INDs) and new drug applications (NDAs), for clinical trial approval, can be in English.

Steps involved in obtaining clinical trial approval in Taiwan

The clinical trial approval process in Taiwan involves several key steps, primarily governed by the Taiwan Food and Drug Administration (TFDA). Here’s a brief overview:

Pre-Submission Consultation: Sponsors can request a pre-submission meeting with the TFDA to discuss study design, regulatory requirements, and any potential issues before formally submitting their application.
Submission of Application: The sponsor submits a Clinical Trial Application (CTA) that includes the study protocol, informed consent forms, and necessary documents such as investigator brochures and ethics committee approvals.
Review by TFDA: The TFDA reviews the application for scientific validity, ethical considerations, and compliance with regulations. This process typically takes around 30 days.
Approval from Ethics Committees: In parallel, a registered Institutional Review Board (IRB) must approve the application to ensure the protection of participants’ rights and welfare.
Commencement of Trials: Once the TFDA and IRB grant their approvals, the trial can begin. The sponsor must adhere to Good Clinical Practice (GCP) guidelines throughout the study.
Monitoring and Reporting: The trial requires ongoing monitoring, and sponsors must report any adverse events or significant findings to the TFDA and IRB.
Final Reporting: After the trial concludes, sponsors must submit a final report to the TFDA that summarizes the results and any adverse events.

This streamlined process, along with the TFDA’s commitment to facilitating research, makes Taiwan an attractive location for conducting clinical trials.

The current process to apply and secure approval process is as follows

The approval process of a clinical trial in Taiwan

Figure 1. The clinical trial approval process in Taiwan (Adapted from http://www.taiwanclinicaltrials.tw/why1.php)

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Many applicants report that, for a general (not US-FDA submitted) clinical trial, it takes about 3 months for the Taiwan FDA to give their approval. For clinical trials, approved by USFDA, approvals are quite faster (about 15 days), as discussed later in this article.

The TFDA issues an import permit for the import of drugs used in clinical trials. Customs will allow investigational product import into Taiwan as per the quantity on the import permit.

Innovative IRB Collaboration System (cIRB) for Multi-center Clinical Trial

In 2013, the CDE established a centralized institutional review board system (cIRB) under the authorization of MOHW to improve the efficiency of case review processes.
The cIRB comprises 9 main IRBs and 21 collaborative IRBs.
Currently, SIDCER/FERCAP (Strategic Initiative for Developing Capacity in Ethical Review/Forum for Ethical Review Committees in the Asian and Western Pacific Region) has certified 23 IRBs, and AAHRPP (Association for the Accreditation of Human Research Protection Programs Inc) has accredited 6 sites.
The main IRBs complete the review process within 20 days whereas the collaborative IRBs complete it within 10 days, but practically, it takes about 1 month or more in the former cases.
However, USFDA-approved trials take less time to approve.

The proven efficiency of cIRB

The collaboration reduced duplication of the full-review board by 71.3%
This also reduces the use of IRB resources and shortens the time investigators spend obtaining approval from IRBs at all participating sites

Innovative IRB Collaboration System (cIRB) for Multi-center Clinical Trial (from 2013)

462 multicentre trials using the system
Out of which, 377 trials underwent the main review process
An average of 9.9 days for the main review process
1195 subsequent expedited reviews
An average of 8 days for the expedited review process
96.6% of cIRB got review results within 20 working days

cIRB Approval Process for Multi-Center Clinical Trials

A multi-site study needs to register with the cIRB system
The main IRB conducts a full board review and completes it in 20 days.
The review records and results are then sent to other IRBs in all participating sites
These IRBs conduct an expedited review which is completed in 10 days

Figure 2. Innovative cIRB system for multi-centered clinical trials in Taiwan (Adapted from http://www.taiwanclinicaltrials.tw/why1.php)

TFDA has developed a fast-track system for clinical trials in Taiwan as part of a global multiregional clinical trial (MRCT), to expedite patient access to new drugs. This is referred to as a Multinational CT notification (CTN) Scheme.
Through this process, the fast-track review can reduce the overall review time to 14 days if the sponsor submits the protocol simultaneously to the US FDA and/or the European Medicines Agency.

Risk management of clinical trials in Taiwan

For better risk management, TFDA classifies the risks as below

Risk-based IND review tracks

Lowest risk IND

Fast track (U.S, FDA-approved IND)
Clinical Trial Notification (CTN)

Intermediate risk IND

TFDA/CDE review team only with or without consulting AC members

Hight risk IND

After review of the TFDA/CDE review team – call an advisory committee for final decision

Multinational CT Notification (CTN) scheme

MRCT protocol was approved by one of the 10 referenced countries: the USA, UK, France, Japan, Switzerland, Canada, Australia, and Sweden.
At least one of Taiwan’s medical centers joins the trial together with sites of referenced countries.
Only administration review by TFDA, no technical evaluation from CDE unless regarded as high risk.
TFDA reserves the right to mend the trial during trial conduction.

The proven efficiency of CTN

Approvals of CTN are growing as well and account for 30% of IND trials

Figure 3. CTN Scheme for multinational clinical trials in Taiwan (Adapted from http://www.taiwanclinicaltrials.tw/why1.php)

In 2009, a bridging study system was developed to provide clinical data on pharmacokinetic/pharmacodynamic (PK/PD) or clinical data on safety, efficacy, dosage, and dose regimen, which will allow extrapolation of the foreign clinical data to different populations. This can greatly help to bring foreign conducted study results to Taiwan. See the details here!

Taiwan: Gate to China Clinical Trial Market

In 2010, the Cross-strait Medicine and Health Cooperation Framework Agreement was signed between Taiwan and China to facilitate the exchange of information in areas of healthcare and clinical research.

The signing of this agreement has resulted in the acceleration of the drug approval process allowing more drugs developed in Taiwan to enter the Chinese market.

Under this agreement, four Taiwanese hospitals are

Taiwan Taipei Veterans General Hospital,
Tri-Service General Hospital,
Taiwan University Medical College Affiliated Hospital, and
Linkou Chang Gung Memorial Hospital

and are now recognized as clinical trial canters by China. Similarly, clinical data from

Peking Union Medical College Hospital,
Peking University First Hospital,
Shanghai Zhongshan Hospital, and
Shanghai Ruijin Hospital, in China,

can be used to apply for an NDA in Taiwan.

The new policy has encouraged multinational companies to carry out clinical trials in Taiwan as the cross-strait agreement and this not only reduces the number of overlapping trials in Taiwan and China but considerably shortens the timeline for getting new drugs into the market.

Summary

Taiwan is emerging as a big player in the Asian clinical trial market.

Strong medical infrastructure including the center of excellence with ICH-GCP compliance
Government support for 6 Phase I centers
Renown international medical technology
- Global top 200 hospitals in Taiwan accounted for 14 after the United States, and Germany ranked 3rd in the world, and first in Asia
- Infant mortality rate is 4.4/1000 persons (USA infant mortality rate is 5.96/1000 persons)
Accredited and adequately operated IRB
- 6 AAHRPP accredited
- Innovative cIRB (IRB collaboration system) for multicenter clinical trials since 2013.
- 96.6% of cIRB submissions get review results within 20 working days.
Well-organized TCTC (Taiwan Clinical Trial Consortium) in 13 specific therapeutic areas.
Proven track record in producing reliable and high-quality data.
Experienced clinical research investigators and nurses.
Efficient and transparent regulatory review system (standard and CTN) for IND.
Conducting a clinical trial in Taiwan may gain a higher reimbursement price.
Bridge to China.

Summary: Taiwan Clinical Research Facts (Adapted from http://www.taiwanclinicaltrials.tw/why1.php)

Need more info or Support?
Feel free to contact us with your questions or if you need any support in Taiwan.

References

http://www.fda.gov.tw/upload/133/Content/2014033109035995639.pdf
http://tc2.ntu.edu.tw/en/
https://clinicaltrials.gov/ct2/results/map?term=multinational+trials&map=ES
SIDCER Recognition Programme. http://www.sidcer.org/new_web/index.php?group=main&open=recognition.php
AAHRPP Accredited Organizations. http://www.aahrpp.org/learn/find-an-accredited-organization
Yang Y-T, Huang H-W, Chen Y-T, et al. Regulation of new drug approval in Taiwan. Ther Innovation Regulatory Sci 2016; 50:602-608.

Disclaimer: Information provided in this blog is not being claimed as official. Applicant is strongly advised to check the recent requirements with relevant authorities.

Understanding Taiwan’s Clinical Trial Regulatory Process: A Comprehensive Guide – Part 2