Taiwan_clinical_trial_regulatory_Credevo

Taiwan is emerging as a big player in the Asian clinical trial market. There are many advantages of conducting clinical trials in Taiwan, which have been discussed in Part 1 of this blog.

Taiwan_clinical_trial_regulatory_Credevo

In this part, let’s talk a bit on 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.

Current process to apply and secure approval process is as follows

credevo_taiwan_clinical_trial_approval_process

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

Many of the applicants have reported that for a general (not US-FDA submitted) clinical trial, it may take about 3 months for 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.

For importing the drugs for clinical trial, It’s needed to get an import permit issued from TFDA. Based on this permit, customs will allow investigational product import into Taiwan as per the quantity on the import permit.

IRB

  • In 2013, a centralized institutional review board system (CIRB) was set up by CDE under the authorization of MOHW to improve the efficiency of case review processes.
  • The CIRB comprises 9 main IRBs and 21 collaborative IRBs.
  • Currently, 23 IRBs are certified by SIDCER/FERCAP (Strategic Initiative for Developing Capacity in Ethical Review/Forum for Ethical Review Committees in the Asian and Western Pacific Region), and 6 sites are accredited to AAHRPP (Association for the Accreditation of Human Research Protection Programs Inc).4,5
  • Although, it has been reported (see below) that the main IRBs complete the review process within 20 days whereas the collaborative IRBs complete it within 10 days, practically, it takes about 1 month or more in the former cases. However, if the trial has been approved by other agencies like USFDA, it takes less time for approval.

credevo_taiwan_clinical_trial_IRB

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

  • To expedite patient access to new drugs, TFDA has developed a fast track system for clinical trials conducted in Taiwan as part of a global multiregional clinical trial (MRCT). It’s referred as Multinational CT notification (CTN) Scheme.
  • Through this process, the overall review time can be reduced to 14 days by a fast track review if the protocol is simultaneously submitted to the US FDA and/or European Medicines Agency.

credevo_taiwan_clinical_trial_notification_approval_process

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 in Taiwan that will allow extrapolation of the foreign clinical data to different populations.’  This can greatly help bringing foreign conducted study results to Taiwan. See 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 healthcare and clinical research.

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, the

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

are now recognized as clinical trial centers 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 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 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.

Taiwan_clinical_research_facts

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

The major advantages of conducting clinical trials in Taiwan are:

  • World class, high quality infrastructure
  • Low cost
  • Dense population, easy patient recruitment process
  • Fast ethical and regulatory submissions
  • Internationally trained healthcare personnel fluent in both English and Chinese
  • Trials comply with ICH-GCP standards

Explore Taiwan Clinical Sites and Investigators

Having understood the regulatory process to be followed for conducting clinical trials in Taiwan, it’s time to explore investigators and sites, where you can conduct these trials.

As explained in this part and part 1 of this article, conducting trials in Taiwan brings a lot of advantages to your clinical development program. Start exploring these advantages by conducting your next trial feasibility with Taiwan investigators.

  1. Just sign up as a trial manager on Credevo, if you’ve not already.
  2. Post your project with required preliminary information.
  3. Credevo team will help you in further process.

If there are any questions or thoughts, let us know by commenting, or contact us here.

References

  1. http://www.fda.gov.tw/upload/133/Content/2014033109035995639.pdf
  2. http://tc2.ntu.edu.tw/en/
  3. https://clinicaltrials.gov/ct2/results/map?term=multinational+trials&map=ES
  4. SIDCER Recognition Programme. http://www.sidcer.org/new_web/index.php?group=main&open=recognition.php
  5. AAHRPP Accredited Organizations. http://www.aahrpp.org/learn/find-an-accredited-organization
  6. 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.

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